GAO-09-250, Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding


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Report to Congressional Requesters: 

United States Government Accountability Office: 
GAO: 

January 2009: 

Dietary Supplements: 

FDA Should Take Further Actions to Improve Oversight and Consumer 
Understanding: 

GAO-09-250: 

GAO Highlights: 

Highlights of GAO-09-250, a report to congressional requesters. 

Why GAO Did This Study: 

Dietary supplements and foods with added dietary ingredients, such as 
vitamins and herbs, constitute multibillion dollar industries. Past 
reports on the Food and Drug Administration’s (FDA) regulation of these 
products raised concerns about product safety and the availability of 
reliable information. Since then, FDA published draft guidance on 
requirements for reporting adverse events—which are harmful effects or 
illnesses—and Current Good Manufacturing Practice regulations for 
dietary supplements. GAO was asked to examine FDA’s (1) actions to 
respond to the new serious adverse event reporting requirements, (2) 
ability to identify and act on concerns about the safety of dietary 
supplements, (3) ability to identify and act on concerns about the 
safety of foods with added dietary ingredients, and (4) actions to 
ensure that consumers have useful information about the safety and 
efficacy of supplements. 

What GAO Found: 

FDA has made several changes in response to the new serious adverse 
event reporting requirements and has subsequently received an increased 
number of reports. For example, FDA has modified its data system, 
issued draft guidance, and conducted outreach to industry. Since 
mandatory reporting went into effect on December 22, 2007, FDA has seen 
a threefold increase in the number of all adverse event reports 
received by the agency compared with the previous year. For example, 
from January through October 2008, FDA received 948 adverse event 
reports—596 of which were mandatory reports submitted by 
industry—compared with 298 received over the same time period in 2007. 
Although FDA has received a greater number of reports since the 
requirements went into effect, underreporting remains a concern, and 
the agency has further actions planned to facilitate adverse event 
reporting. 

FDA has taken some steps to identify and act upon safety concerns 
related to dietary supplements; however, several factors limit the 
agency’s ability to detect concerns and remove products from the 
market. For example, FDA has limited information on the number and 
location of dietary supplement firms, the types of products currently 
available in the marketplace, and information about moderate and mild 
adverse events reported to industry. Additionally, FDA dedicates 
relatively few resources to oversight activities, such as providing 
guidance to industry regarding notification requirements for products 
containing new dietary ingredients. Also, once FDA has identified a 
safety concern, the agency’s ability to remove a product from the 
market is hindered by a lack of mandatory recall authority and the 
difficult process of demonstrating significant or unreasonable risk for 
specific ingredients. 

Although FDA has taken some actions when foods contain unsafe dietary 
ingredients, certain factors may allow potentially unsafe products to 
reach consumers. FDA may not know when a company has made an 
unsupported or incorrect determination about whether an added dietary 
ingredient in a product is generally recognized as safe until after the 
product becomes available to consumers because companies are not 
required to notify FDA of their self-determinations. In addition, the 
boundary between dietary supplements and conventional foods containing 
dietary ingredients is not always clear, and some food products could 
be marketed as dietary supplements to circumvent the safety standard 
required for food additives. 

FDA has taken limited steps to educate consumers about dietary 
supplements, and studies and experts indicate that consumer 
understanding is lacking. While FDA has conducted some outreach, these 
initiatives have reached a relatively small proportion of dietary 
supplement consumers. Additionally, surveys and experts indicate that 
consumers are not well-informed about the safety and efficacy of 
dietary supplements and have difficulty interpreting labels on these 
products. Without a clear understanding of the safety, efficacy, and 
labeling of dietary supplements, consumers may be exposed to greater 
health risks associated with the uninformed use of these products. 

What GAO Recommends: 

GAO recommends that the Secretary of Health and Human Services direct 
the Commissioner of the FDA to request additional authority to oversee 
dietary supplements, issue guidance on new dietary ingredients and to 
clarify the boundary between dietary supplements and foods with added 
dietary ingredients, and take steps to improve consumer understanding 
of dietary supplements. In commenting on this report, FDA generally 
agreed with GAO’s recommendations. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/products/GAO-09-250]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

FDA Has Made Changes in Response to the New Serious Adverse Event 
Reporting Requirements and Has Received an Increased Number of Reports: 

Although FDA Has Taken Some Steps to Identify and Act on Concerns about 
the Safety of Dietary Supplements, Several Factors Limit Its Oversight: 

While FDA Has Taken Some Actions When Foods Contain Unsafe Dietary 
Ingredients, Certain Factors May Allow Unsafe Products to Reach 
Consumers: 

FDA Has Taken Limited Steps to Educate Consumers about Dietary 
Supplements, and Consumers Remain Largely Uninformed: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Data on FDA's Actions to Identify and Respond to Safety 
Concerns Related to Dietary Supplements: 

Appendix III: Comparison of Select Foreign Countries' Regulation of 
Dietary Supplements with the United States: 

Appendix IV: Comments from the Department of Health and Human Services: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Key Events in the Regulation of Dietary Supplements: 

Table 2: Number of Cases with Mandatory Reported Adverse Event Outcomes 
by Dietary Supplement Product Classification, from December 22, 2007, 
through October 31, 2008: 

Table 3: Examples of FDA Surveillance to Identify Safety Concerns: 

Table 4: Examples of FDA Actions in Response to Identified Safety 
Concerns: 

Table 5: Examples of FDA Actions Taken on Dietary Supplement 
Ingredients That Have Been Banned in Other Countries: 

Table 6: Comparison of the Number of Adverse Event Reports Received and 
Entered into FDA's Databases for Review Related to Dietary Supplements 
and Drugs and Biologics, January 1, 2003, through December 31, 2007: 

Table 7: Number of Dietary Supplement-Related Adverse Event Cases 
Characterized as Serious, January 1, 2003, through October 31, 2008: 

Table 8: Number of Dietary Supplement-Related Adverse Event Complaint 
(AEC) Outcomes for all Adverse Event Cases, January 1, 2003, through 
October 31, 2008: 

Table 9: Number of All Dietary Supplement-Related Cases with Reported 
Adverse Event Outcomes by Product Classification, January 1, 2003, 
through October 31, 2008: 

Table 10: Number of Dietary Supplement-Related Consumer Complaints by 
Adverse Event Result, Fiscal Year 2001 through July 3, 2008: 

Table 11: Number of Dietary Supplement-Related Consumer Complaints with 
Adverse Symptoms Present by Adverse Event Result and Product 
Classification, Fiscal Year 2001 through July 3, 2008: 

Table 12: FDA Foreign and Domestic Inspections and State Domestic 
Inspections, Fiscal Years 2000 through 2008: 

Table 13: Share of Dietary Supplement Inspections Where Investigators 
Identified Problems, Fiscal Year 2002 through May 6, 2008: 

Table 14: Number of Violations in the Federal Food, Drug, and Cosmetic 
Act Cited in 293 FDA Dietary Supplement-Related Warning Letters, Fiscal 
Years 2002 through 2007: 

Table 15: FDA Dietary Supplement-Related Warning Letters and All Other 
FDA Warning Letters Issued, Fiscal Years 2002 through 2007: 

Table 16: Examples of Dietary Supplement-Related Class I Recalls, 
Fiscal Years 2003 through 2008: 

Table 17: Dietary Supplement-Related Detentions without Physical 
Examination (DWPE) by General Violation Categories, Fiscal Year 2002 
through March 24, 2008: 

Table 18: Dietary Supplement-Related DWPE by Product Classification, 
Fiscal Year 2002 through March 24, 2008: 

Table 19: Number of Violations of the Federal Food, Drug, and Cosmetic 
Act Cited in 3,605 Dietary Supplement-Related Import Refusals, Fiscal 
Year 2002 through March 24, 2008: 

Table 20: Dietary Supplement-Related Import Refusals by Product 
Classification, Fiscal Year 2002 through March 24, 2008: 

Table 21: FDA Seizures and Injunctions Related to Dietary Supplement 
Products, Fiscal Year 2002 through July 18, 2008: 

Table 22: Number of Criminal Investigations Related to Dietary 
Supplements Resulting in a Conviction or Charges Filed from 2002 
through July 31, 2008: 

Table 23: Comparison of Dietary Supplement Regulations: United States, 
Canada, United Kingdom, and Japan: 

Figures: 

Figure 1: Total Sales of Dietary Supplements in the United States from 
1997 through 2007: 

Figure 2: The Number of Dietary Supplement-Related Adverse Event 
Reports to CAERS from January 1, 2003, to October 31, 2008: 

Abbreviations: 

AEC: adverse event complaint: 

CAERS: CFSAN Adverse Event Reporting System: 

CFSAN: Center for Food Safety and Applied Nutrition: 

DSHEA: Dietary Supplement Health and Education Act of 1994: 

DWPE: detentions without physical examination: 

EC: European Community: 

FDA: Food and Drug Administration: 

FNFC: Food with Nutrient Function Claims: 

FOSHU: Foods for Specified Health Uses: 

GRAS: generally recognized as safe: 

NIH: National Institutes of Health: 

UK: United Kingdom: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

January 29, 2009: 

The Honorable Henry A. Waxman: 
Chairman: 
The Honorable John D. Dingell: 
Chairman Emeritus: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Bart Stupak: 
Chairman: 
Subcommittee on Oversight and Investigations: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Richard J. Durbin: 
United States Senate: 

Dietary supplements and foods containing added dietary ingredients, 
such as vitamins and herbs, constitute growing multibillion dollar 
industries. Sales of dietary supplements alone reached approximately 
$23.7 billion in 2007, and data from the 2007 National Health Interview 
Survey show that over half of all U.S. adults consume dietary 
supplements. In 1994, there were approximately 4,000 dietary supplement 
products on the market, whereas an industry source estimated that, in 
2008, about 75,000 dietary supplement products were available to 
consumers. Similarly, food products--such as fortified cereals and 
energy drinks--that contain added dietary ingredients are in the 
marketplace in unprecedented numbers, and consumers are expected to 
spend increasing amounts on these products over the next several years. 

The Food and Drug Administration (FDA) regulates dietary supplements 
under provisions of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Dietary Supplement Health and Education Act of 1994 
(DSHEA). DSHEA defines dietary supplements as products that, among 
other things, are intended for ingestion to supplement the diet, 
labeled as a dietary supplement, and not represented as a conventional 
food or as a sole item of a meal or diet. They must also contain one or 
more dietary ingredients. DSHEA does not require manufacturers to 
register with FDA or identify the products they manufacture or the 
ingredients of those products. However, all food facilities, including 
manufacturers and distributors of dietary supplements, were required to 
register with FDA no later than December 12, 2003, under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
and implementing regulations. This includes an initial registration 
with FDA and updates within 60 days of any changes in information. 
Registration must include the name and address of the facility and an 
emergency contact, and facilities that manufacture or sell certain 
types of products, such as vitamins, must self-identify as such. 

Under DSHEA, dietary supplements are broadly presumed safe, and FDA 
does not have the authority to require them to be approved for safety 
and efficacy before they enter the market, as it does for drugs. 
However, a dietary supplement manufacturer or distributor of a 
supplement with a "new dietary ingredient"--an ingredient that was not 
marketed in the United States before October 15, 1994--may be required 
to notify FDA at least 75 days before marketing the product, depending 
on the history of use of the ingredient. For the most part, FDA relies 
on post-market surveillance efforts--such as monitoring adverse event 
reports it receives from companies, health care practitioners, and 
individuals; reviewing consumer complaints; and conducting facility 
inspections--to identify potential safety concerns related to dietary 
supplements. Once a safety concern is identified, FDA must demonstrate 
that the dietary supplement presents a significant or unreasonable 
risk, or is otherwise adulterated, before it can be removed from the 
market. According to several experts we spoke with, this regulatory 
approach has fallen short in protecting U.S. consumers in the past. For 
example, while FDA was successful, in 2004, in banning ephedrine 
alkaloids (ephedra)--a dietary ingredient used for weight loss and 
bodybuilding, among other things--the ban became effective only after 
FDA had received thousands of reports of adverse events, including a 
number of deaths, and 10 years after the agency issued its first 
advisory. 

Since ephedra was banned, several changes have occurred in the 
regulation of dietary supplements. For example, the Federal Food, Drug, 
and Cosmetic Act, as amended by the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act, requires companies that 
receive a serious adverse event report to submit information about the 
event to FDA, beginning in December 2007. As defined in the act, 
serious adverse events include any health-related events that result 
in, for example, a death, life-threatening experience, inpatient 
hospitalization, birth defect, or which require, based on reasonable 
medical judgment, a medical or surgical intervention to prevent these 
serious outcomes. While the act does not require companies to report 
moderate or mild adverse events, such as gastrointestinal distress or 
headaches, companies may do so voluntarily. In addition, health care 
practitioners and consumers can submit voluntary reports of serious, 
moderate, and mild adverse events. Additionally, in an effort to 
improve the consistency and safety of dietary supplements, in June 
2007, FDA established its Current Good Manufacturing Practice 
regulations describing the conditions under which supplements must be 
manufactured, packed, and held. These requirements are being 
implemented in phases, based on company size, and will be fully in 
effect by 2010. 

In addition to regulating the safety and labeling of dietary 
supplements, FDA also conducts outreach to consumers about these 
products. While the Federal Food, Drug, and Cosmetic Act does not 
explicitly require FDA to conduct consumer education, according to the 
agency, it has some responsibility for doing so. 

FDA also regulates foods with added dietary ingredients under 
provisions set out in the Federal Food, Drug, and Cosmetic Act. The act 
generally requires that when a company adds an ingredient to a food 
product, that ingredient must either be generally recognized as safe 
(GRAS) or go through FDA's review and approval process as a food 
additive. With some exceptions, the company is responsible for 
determining that the ingredient meets the GRAS standard or, failing 
this, for having it approved as a food additive. The GRAS standard is 
defined as a general recognition among qualified experts that the 
substance is reasonably certain to not be harmful under its intended 
conditions of use; such recognition can come through scientific 
procedures, or for substances in use prior to 1958, through experience 
based on common use in food. If the added ingredient is GRAS, the 
company may add the ingredient to a food product without notifying FDA, 
although some do so voluntarily. In most instances, if the ingredient 
does not meet the GRAS standard, the company must petition FDA for 
approval of the ingredient as a food additive, which also requires 
companies to demonstrate a reasonable certainty that the ingredient is 
not harmful under the intended conditions of use. According to FDA, 
meeting the safety standard for a food additive requires the same 
quantity and quality of scientific evidence as is needed to satisfy the 
GRAS standard. 

In July 2000, we reported concerns about the safety of dietary 
supplements and foods with added dietary ingredients, as well as about 
the accuracy of health-related claims on product labels and in 
advertising.[Footnote 1] More specifically, we reported that consumers 
faced health risks because federal laws and agencies' efforts did not 
effectively and consistently ensure that products were safe. 
Furthermore, we found that consumers did not consistently receive 
clear, scientifically supported information concerning products' health 
benefits so they could make informed dietary choices. To help ensure 
that dietary supplements and related products are safe and that 
consumers receive accurate information about the products, we made six 
recommendations to FDA. FDA has implemented two of these 
recommendations but has not fully implemented the remaining four, which 
deal largely with providing regulations or other information clarifying 
industry responsibilities. 

At your request, this report examines FDA's (1) actions to respond to 
the new serious adverse event reporting requirements; (2) ability to 
identify and act on concerns about the safety of dietary supplements; 
(3) ability to identify and act on concerns about the safety of foods 
with added dietary ingredients; and (4) actions to educate consumers 
about the safety, efficacy, and labeling of dietary supplements. 

For this report, dietary supplement means a product intended for human 
consumption and does not include products for veterinary use. 
Additionally, for this report, dietary ingredient means an ingredient 
that is included in the dietary supplement definition in DSHEA, such as 
vitamins, minerals, and herbs or other botanicals. To identify FDA's 
actions to respond to the new serious adverse event reporting 
requirements, we reviewed FDA's guidance on reporting requirements for 
industry and internal procedures for compiling and tracking adverse 
event reports; analyzed the number of reports received before and after 
the requirements went into effect; and reviewed plans for improving 
adverse event reporting. To examine FDA's ability to identify and act 
on safety concerns associated with dietary supplements, we assessed 
FDA's laws and regulations; analyzed data on FDA's oversight actions, 
such as inspections, import screenings and enforcement activities; and 
reviewed FDA resources dedicated to dietary supplements. To examine 
FDA's ability to identify and act on concerns about the safety of foods 
with added dietary ingredients, we reviewed laws and regulations 
regarding food additives, as well as FDA's procedures for identifying 
and acting on concerns about the safety of foods with added dietary 
ingredients. To determine what FDA has done to educate consumers about 
the safety, efficacy, and labeling of dietary supplements, we reviewed 
FDA's consumer outreach initiatives and analyzed FDA's and others' data 
on consumer understanding of dietary supplements. In addition, to 
address all of our objectives, we interviewed a wide range of 
stakeholders, including officials from federal and state agencies, 
industry and trade organizations, consumer advocacy groups, academia, 
poison control centers, and foreign governments. To assess the 
reliability of the data from FDA's databases used in this report, we 
reviewed related documentation, examined the data to identify obvious 
errors or inconsistencies, and worked with agency officials to identify 
any data problems. We determined the data to be sufficiently reliable 
for the purposes of this report. A more detailed description of our 
objectives, scope, and methodology is presented in appendix I. 

We conducted this performance audit from December 2007 to January 2009, 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

In 2007, FDA took several actions in response to the new serious 
adverse event reporting requirements for dietary supplements and has 
subsequently received an increased number of reports. Specifically, FDA 
has incorporated the mandatory reports into its existing data system 
for compiling, tracking, and reviewing adverse event reports. FDA has 
also issued draft guidance and conducted outreach to industry regarding 
the new reporting requirements. For example, in October 2007, FDA 
provided companies with a form and instructions for submitting 
mandatory serious adverse event reports and issued draft guidance 
outlining requirements and recommendations for reporting, 
recordkeeping, and records access. Furthermore, FDA has worked with 
industry associations to increase awareness of the new reporting 
requirements. Since mandatory reporting requirements went into effect, 
the agency has seen a threefold increase in the number of all adverse 
events reported compared with the previous year. For example, from 
January through October 2008, FDA received 948 adverse event reports, 
compared with 298 received over the same time period in 2007. Of the 
948 adverse event reports, 596 were mandatory reports of serious 
adverse events submitted by industry; the remaining 352 were voluntary 
reports, which include all moderate and mild adverse events reported 
and any serious adverse events reported by health care practitioners 
and consumers directly to FDA. However, FDA recently estimated that the 
actual number of total adverse events--including mild, moderate, and 
serious--related to dietary supplements per year is over 50,000, which 
suggests that underreporting of adverse events limits the amount of 
information FDA receives. To facilitate adverse event reporting for all 
FDA-regulated products, FDA is currently developing MedWatchPlus, an 
interactive Web-based portal intended to simplify the reporting process 
and reduce the time and cost associated with reviewing paper reports. 

Although FDA has used varied approaches--such as analyzing adverse 
events and conducting inspections--to identify safety concerns and has 
taken some actions--such as detaining certain potentially unsafe 
imported products--in response to these concerns, several factors limit 
FDA's ability to further identify and act on safety concerns. First, 
FDA's ability to identify safety concerns is hindered by a lack of 
information. For example, while all dietary supplement companies must 
register with FDA as food facilities to provide their name and address, 
some companies--such as those specializing exclusively in herbal 
products--are not required to identify themselves as dietary supplement 
companies. In addition, companies are not required to provide FDA with 
information on the products they sell, such as the product name and 
ingredients. As a result, FDA has limited information on the companies 
and products it is required to regulate, and more complete information 
could help FDA analyze adverse event reports. Moreover, dietary 
supplement companies are required to report only serious adverse 
events. FDA officials have noted that receiving adverse event reports 
for moderate and mild events could improve the agency's ability to 
assess safety-related signals from adverse event data. Second, in 
comparison to other regulated products, FDA dedicates relatively few 
resources to dietary supplement oversight activities. For example, FDA 
has conducted relatively few dietary supplement inspections and has not 
developed guidance for industry regarding key safety-related aspects of 
DSHEA in a timely manner. In particular, FDA has not yet issued 
guidance to clarify new dietary ingredient notification requirements. 
Third, once FDA has identified a safety concern, its ability to 
efficiently and effectively remove a product from the market is 
limited. For example, FDA lacks mandatory recall authority, and FDA's 
ability to ban an unsafe ingredient has proven difficult because the 
Federal Food, Drug, and Cosmetic Act requires that the agency 
demonstrate a significant or unreasonable risk or that the dietary 
supplement is otherwise adulterated. This statutory requirement is 
exacerbated by limited scientific research and underreporting of 
adverse events. Although FDA has taken some steps, such as drafting 
guidance for industry on reporting serious adverse events and 
establishing its Current Good Manufacturing Practice regulations, to 
improve the oversight of dietary supplements over the past several 
years, consumers remain vulnerable to risks posed by potentially unsafe 
products. 

Similar to dietary supplements, while FDA has taken some actions, such 
as issuing warnings, when foods contain unsafe dietary ingredients, 
certain factors may allow some unsafe products to reach consumers. For 
example, FDA may not know when a company has made an unsupported or 
incorrect GRAS determination about an added dietary ingredient in a 
product until after the product becomes available to consumers because 
companies are not required to notify FDA of their self-determinations. 
In addition, the boundary between dietary supplements and foods with 
added dietary ingredients is not always clear, and some food products 
could be marketed as dietary supplements to circumvent the safety 
standard required for food additives. For example, in August 2007, FDA 
identified a company marketing an iced tea mix containing stevia--an 
herb that has not been approved as a food additive because of potential 
safety concerns, including reproductive and cardiovascular effects. FDA 
issued a warning to the company, and the company changed the product 
label to classify the product as a dietary supplement rather than a 
food so that it could continue to add stevia to its product. As a 
dietary supplement, FDA does not have the authority to require that the 
safety of the product be approved. Finally, FDA conducts limited 
monitoring of foods with added dietary ingredients. According to FDA, 
it does not track these products separately from other conventional 
foods, and the current regulatory framework is sufficient to identify 
and act on safety concerns related to these products. Some stakeholders 
we spoke with noted that safety risks associated with foods containing 
added dietary ingredients that meet the GRAS standard or have been 
approved as food additives are generally low. However, some 
stakeholders expressed concerns about certain products, such as energy 
drinks, and adding botanicals to foods. 

FDA has taken limited steps to educate consumers about the safety, 
efficacy, and labeling of dietary supplements, and studies and experts 
indicate that consumer understanding about these products is lacking. 
While FDA has conducted some consumer outreach, such as distributing 
brochures and providing information its Web site, these initiatives 
have reached a relatively small proportion of consumers using dietary 
supplements. For instance, a 2004 brochure developed in conjunction 
with the National Institutes of Health (NIH) had a distribution of 
40,000 paper copies and received approximately 171,000 page views on 
the Web. However, data from the 2007 National Health Interview Survey 
show that over half of U.S. adults--or at least 114 million 
individuals--take dietary supplements. While officials noted that the 
agency must continually market its desired messages to effectively 
educate consumers, FDA's Center for Food Safety and Applied Nutrition 
(CFSAN) currently is not planning any new consumer education 
initiatives for dietary supplements. In addition, agency officials 
stated that FDA does not evaluate the effectiveness of its outreach 
efforts; however, surveys and experts indicate that consumers are not 
well-informed about factors that can affect the safety and efficacy of 
dietary supplements. For example, a 2002 Harris Poll indicated that a 
majority of adults believe that a government agency approves dietary 
supplements before products are marketed to consumers. Studies also 
suggest that the labeling of dietary supplements can be confusing to 
consumers. For example, in 2003, the Department of Health and Human 
Services' Inspector General reported that dietary supplement labels 
often do not present information in a manner that facilitates consumer 
understanding.[Footnote 2] Without a clear understanding of the safety, 
efficacy, and labeling of dietary supplements, consumers are exposed to 
risks--such as potentially harmful drug-supplement interactions-- 
associated with the uninformed use of these products. 

To improve the information available to FDA for identifying safety 
concerns, we are recommending that the Secretary of the Department of 
Health and Human Services direct the Commissioner of FDA to seek 
additional authority to require dietary supplement facilities to self- 
identify as part of existing registration requirements, provide a list 
of their products and a copy of the labels, and report all adverse 
events related to dietary supplements. To better enable FDA to regulate 
dietary supplements with new dietary ingredients, we are recommending 
that the Secretary of the Department of Health and Human Services 
direct the Commissioner of FDA to issue guidance to clarify when an 
ingredient is considered a new dietary ingredient, what evidence is 
needed to document the safety of new dietary ingredients, and 
appropriate methods for establishing ingredient identity. To help 
ensure that companies follow the appropriate laws and regulations, we 
are recommending that the Secretary of the Department of Health and 
Human Services direct the Commissioner of FDA to provide guidance to 
industry to clarify when products should be marketed as either dietary 
supplements or conventional foods formulated with added dietary 
ingredients. We made a similar recommendation in our July 2000 report, 
but, according to FDA, it did not implement the recommendation because 
of resource constraints and competing agency priorities and activities. 
To improve consumer understanding about dietary supplements and better 
leverage existing resources, we are recommending that the Secretary of 
the Department of Health and Human Services direct the Commissioner of 
FDA to coordinate with stakeholder groups to identify additional 
mechanisms to educate consumers, implement these mechanisms, and assess 
their effectiveness. In commenting on our draft report, FDA generally 
agreed with our recommendations. 

Background: 

According to the Nutrition Business Journal, the dietary supplement 
industry is growing, and total sales were about $23.7 billion in 2007, 
as shown in figure 1. Top selling supplements in 2007 included 
multivitamins, sports nutrition powders and formulas, and calcium, 
according to the Nutrition Business Journal. In addition, one of the 
areas of greatest growth in supplements within the United States in 
2007 was among weight loss products. Projections through 2011 show that 
growth in the industry is expected to continue, in large part because 
of the aging population and an increasing interest in personal health 
and wellness. 

Figure 1: Total Sales of Dietary Supplements in the United States from 
1997 through 2007: 

[Refer to PDF for image: vertical bar graph] 

Year: 1997; 
Total Sales: $13.95 billion. 

Year: 1998; 
Total Sales: $15.45 billion. 

Year: 1999; 
Total Sales: $16.46 billion. 

Year: 2000; 
Total Sales: $17.27 billion. 

Year: 2001; 
Total Sales: $18.08 billion. 

Year: 2002; 
Total Sales: $18.75 billion. 

Year: 2003; 
Total Sales: $19.81 billion. 

Year: 2004; 
Total Sales: $20.39 billion. 

Year: 2005; 
Total Sales: $21.32 billion. 

Year: 2006; 
Total Sales: $22.46 billion. 

Year: 2007; 
Total Sales: $23.7 billion. 

Source: GAO analysis of Nutrition Business Journal data. 

[End of figure] 

Over time, several key events have shaped the regulation of dietary 
supplements, as shown in table 1. Significantly, Congress passed DSHEA, 
which amended the Federal Food, Drug, and Cosmetic Act and created a 
new regulatory category, safety standard, and other requirements for 
supplements. Under DSHEA, dietary supplements are generally presumed 
safe. With the exception of the banned dietary ingredient, ephedra, 
companies may sell otherwise lawful products containing any dietary 
ingredient that was marketed in the United States prior to October 15, 
1994--referred to as "grandfathered ingredients"--without notifying 
FDA. Ingredients that were not marketed before this date are considered 
new dietary ingredients. A dietary supplement containing a new dietary 
ingredient must meet one of the two following requirements: (1) it 
contains only dietary ingredients that have been "present in the food 
supply as an article used for food in a form in which the food has not 
been chemically altered" or (2) there is evidence that the dietary 
ingredient is reasonably expected to be safe under the conditions of 
use recommended or suggested in the product's labeling. In addition, 
companies planning to market a dietary supplement with a new dietary 
ingredient that only meets the second requirement must notify FDA of 
the evidence that is the basis of the determination at least 75 days 
before marketing the supplement. 

Table 1: Key Events in the Regulation of Dietary Supplements: 

Year: 1990; 
Key event: The Nutrition Labeling and Education Act of 1990 amended the 
Federal Food, Drug, and Cosmetic Act to require most foods, including 
dietary supplements, to bear nutrition labeling. 

Year: 1994; 
Key event: DSHEA amended the Federal Food, Drug, and Cosmetic Act to 
create a new regulatory category, safety standard, labeling 
requirements, and other rules for dietary supplements. Under DSHEA, 
dietary supplements are generally presumed to be safe. 

Year: 2002; 
Key event: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act 
to require all food companies, including dietary supplement companies, 
to register with FDA no later than December 12, 2003, to provide 
information on the name and address of the facility and, to some 
extent, the types of products they manufacture or sell. 

Year: 2004; 
Key event: FDA was successful in banning ephedra after thousands of 
adverse events, including a number of deaths, and a lengthy legal 
process. 

Year: 2006; 
Key event: The Dietary Supplement and Nonprescription Drug Consumer 
Protection Act amended the Federal Food, Drug, and Cosmetic Act to 
require dietary supplement companies that receive a serious adverse 
event report to submit information about the event to FDA. 

Year: 2007; 
Key event: FDA finalized its Current Good Manufacturing Practice 
regulations to establish quality control standards for dietary 
supplements. The final rule became effective on August 24, 2007, but 
companies have 10, 22, or 34 months from the effective date of the rule 
to comply, depending on company size. 

Year: 2007; 
Key event: Serious adverse event reporting requirements for dietary 
supplement companies became effective on December 22. 

Source: GAO. 

[End of table] 

As of December 22, 2007, dietary supplement companies are required to 
submit any report received about a serious adverse event to FDA, as 
mandated by the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act. In addition, companies can voluntarily submit reports 
about moderate and mild adverse events. Others, such as consumers and 
health care practitioners, can submit reports of serious, moderate, and 
mild adverse events on a voluntary basis to FDA. Prior to implementing 
the mandatory reporting requirements, FDA's Center for Food Safety and 
Applied Nutrition--which, in part, is responsible for promoting and 
protecting the public's health by ensuring that the nation's food 
supply is safe, sanitary, wholesome, and honestly labeled--had a system 
in place to receive voluntary reports of adverse events involving 
dietary supplements from all parties. 

As stated in the Federal Food, Drug, and Cosmetic Act, FDA is also 
responsible for protecting the public health by ensuring that the 
labels of dietary supplements are not false or misleading. As noted in 
table 1, the Nutrition Labeling and Education Act of 1990 amended the 
Federal Food, Drug, and Cosmetic Act to require that most foods, 
including dietary supplements, bear nutrition labeling. In addition, 
DSHEA amended the Federal Food, Drug, and Cosmetic Act to add specific 
labeling requirements for dietary supplements and provided for optional 
labeling statements. Federal regulations require the following 
information on the labels of dietary supplements: (1) product identity 
(name of the dietary supplement), (2) net quantity of contents 
statement (amount of the dietary supplement in the package), (3) 
nutrition labeling, (4) ingredient list (when appropriate), and (5) 
name and place of business of the manufacturer, packer, or distributor. 
In addition, DSHEA specifies that supplements with labeling that makes 
disease or health-related claims must contain a disclaimer that FDA has 
not evaluated the claim and the product is not intended to diagnose, 
treat, cure, or prevent any disease. 

Similar to dietary supplements, the market for foods with added dietary 
ingredients has been growing, and this trend is expected to continue. 
Foods with added dietary ingredients vary greatly, including such 
products as orange juice with added calcium, pasta with Omega 3, and 
sunflower seeds with guarana. Terms such as "functional foods" and 
"nutraceuticals" are sometimes used to describe foods with added 
dietary ingredients. However, there are no regulatory definitions for 
these terms, and some of these terms include foods with naturally 
beneficial properties beyond nutrition, such as pomegranate juice. 

FDA Has Made Changes in Response to the New Serious Adverse Event 
Reporting Requirements and Has Received an Increased Number of Reports: 

FDA has made several changes in response to the new serious adverse 
event reporting requirements established by law in 2006 and has 
subsequently received an increased number of reports. FDA has modified 
its existing data system and internal procedures for compiling, 
tracking, and reviewing adverse event reports to incorporate mandatory 
reporting by industry. Additionally, FDA has issued draft guidance and 
conducted outreach to industry regarding the new requirements. Since 
mandatory reporting went into effect on December 22, 2007, FDA has seen 
a threefold increase in the number of all adverse event reports 
received by the agency compared with the previous year. Although FDA 
received more reports overall since the reporting requirements went 
into effect, underreporting of adverse events remains a concern, and 
the agency has further actions planned to facilitate adverse event 
reporting by consumers, health care practitioners, and industry. 

FDA Has Taken Several Actions in Response to the New Serious Adverse 
Event Reporting Requirements: 

In 2007, FDA took several actions in response to the new serious 
adverse event reporting requirements for dietary supplements. 
Specifically, FDA modified its existing database for compiling, 
tracking, and reviewing adverse event reports--the CFSAN Adverse Event 
Reporting System (CAERS)--to include data fields and instructions 
specifically for compiling and tracking mandatory reports. In addition, 
CFSAN established procedures for reviewing mandatory serious adverse 
event reports to determine if they meet the minimum data requirements 
for mandatory reports outlined in guidance to the industry. 

FDA has also issued draft guidance and conducted outreach to industry 
regarding the new reporting requirements. In October 2007, FDA provided 
companies with a form and instructions for submitting mandatory serious 
adverse event reports and issued draft guidance describing statutory 
requirements and agency recommendations for reporting, recordkeeping, 
and records access. Additionally, in December 2007, FDA issued draft 
guidance on labeling requirements. 

Statutory requirements outlined in draft guidance include the 
following: 

* The manufacturer, packer, or distributor whose name appears on the 
dietary supplement label (responsible party) must report all serious 
adverse events to FDA, as well as follow up medical information 
received within 1 year after the initial report, within 15 business 
days of receipt. 

* Mandatory serious adverse event reports must be submitted to FDA 
using the MedWatch 3500A form and should contain the following minimum 
data elements: an identifiable injured person, name of the person who 
first notified the responsible party, identity and contact information 
for the responsible party, a suspect dietary supplement, and a serious 
adverse event or fatal outcome. 

* The responsible party must include a copy of the dietary supplement 
label related to the serious adverse event. 

* The responsible party must maintain records of all adverse events 
reported for 6 years and must provide FDA officials with access to the 
records upon request during an inspection. 

* Labels for dietary supplements marketed in the United States must 
provide a complete domestic mailing address or phone number where the 
responsible party may receive adverse event reports. 

In addition to these requirements, FDA recommended that firms include 
an introductory statement on dietary supplement labels to inform 
consumers that the contact information provided may be used to report a 
serious adverse event. According to comments submitted to FDA by the 
three major dietary supplement industry associations, although the 
industry broadly supports the new mandatory reporting requirements, it 
disagrees with the recommended labeling changes. These industry 
associations cite the following three key reasons for their opposition 
to FDA's recommendation: (1) in their view, the changes are unnecessary 
and beyond Congress' intent; (2) the introductory statement may draw 
undue attention to the possibility of an adverse event and confuse 
consumers; and (3) redesigning and replacing product labels is a 
substantial added expense for dietary supplement companies and should 
have been proposed through a formal rulemaking process rather than 
guidance. According to an FDA official, the draft guidance regarding 
reporting, recordkeeping, and records access requirements is close to 
being finalized. In December 2008, FDA issued a revision of the draft 
guidance regarding labeling changes. According to FDA, before this 
guidance is finalized, it will need to be reviewed by the Office of 
Management and Budget because of its potential economic impact on 
industry. 

FDA has also worked with industry associations to increase awareness of 
the new reporting requirements. For instance, FDA officials have spoken 
at industry-sponsored conferences and seminars to increase awareness 
and answer questions about the new reporting requirements. 
Representatives from two of the leading industry associations we spoke 
with stated that they were generally satisfied with FDA's outreach 
efforts regarding mandatory reporting. 

FDA Has Received an Increased Number of Adverse Event Reports Since 
Mandatory Reporting Went into Effect: 

Since mandatory reporting requirements went into effect, the agency has 
seen a threefold increase in the number of all adverse events reported 
compared with the previous year. For example, from January through 
October 2008, FDA received 948 adverse event reports, compared with 298 
received over the same time period in 2007. Of the 948 adverse event 
reports, 596 were mandatory reports of serious adverse events submitted 
by industry; the remaining 352 were voluntary reports, which include 
all moderate and mild adverse events reported and any serious adverse 
events reported by health care practitioners and consumers directly to 
FDA. As shown in figure 2, FDA received more serious adverse event 
reports between January 1, 2008, and October 31, 2008, than previous 
years, including 2003 and 2004, when FDA was receiving adverse event 
reports related to ephedra. Adverse event reports from January 1, 2008, 
through October 31, 2008, include 596 serious adverse event reports 
submitted by industry, 163 serious adverse events reported by others on 
a voluntary basis, and 189 moderate and mild adverse event reports. 

Figure 2: The Number of Dietary Supplement-Related Adverse Event 
Reports to CAERS from January 1, 2003, to October 31, 2008: 

[Refer to PDF for image: stacked vertical bar graph] 

Year: 2003; 
Voluntary reports characterized as serious: 510; 
Mandatory reports (all serious): 0; 
Voluntary reports characterized as non-serious: 229; 
Total: 739. 

Year: 2004; 
Voluntary reports characterized as serious: 483; 
Mandatory reports (all serious): 0; 
Voluntary reports characterized as non-serious: 174; 
Total: 657. 

Year: 2005; 
Voluntary reports characterized as serious: 364; 
Mandatory reports (all serious): 0; 
Voluntary reports characterized as non-serious: 127; 
Total: 491. 

Year: 2006; 
Voluntary reports characterized as serious: 213; 
Mandatory reports (all serious): 0; 
Voluntary reports characterized as non-serious: 104; 
Total: 317. 

Year: 2007; 
Voluntary reports characterized as serious: 213; 
Mandatory reports (all serious): 0; 
Voluntary reports characterized as non-serious: 137; 
Total: 350. 

Year: January 1 - October 31, 2008; 
Voluntary reports characterized as serious: 163; 
Mandatory reports (all serious): 596; 
Voluntary reports characterized as non-serious: 189; 
Total: 948. 

Source: GAO analysis of FDA data. 

Note: There were 36 reports that did not include information about 
seriousness in 2003. FDA officials noted that, prior to the ban on 
ephedra in 2004, the agency received a heightened number of adverse 
event reports due to products containing ephedra. Although mandatory 
reporting went into effect on December 22, 2007, FDA did not receive 
its first mandatory report until January 2008. 

[End of figure] 

Since mandatory reporting went into effect, FDA had received 596 
mandatory reports of adverse events, such as serious cardiac, 
respiratory, and gastrointestinal disorders, as of October 31, 2008. 
Among other results, these events involved 9 deaths, 64 life- 
threatening illnesses, and 234 patient hospitalizations. As shown in 
table 2, 66 percent of serious adverse event reports were associated 
with dietary supplements that either contained a combination of types 
of products, such as a product containing both vitamins and herbals, or 
could not be categorized under one of FDA's other product 
classifications, and 40 percent were associated with vitamins. However, 
according to FDA, because of variability in the quality and detail of 
information in reports and the lack of a control group, the agency 
cannot necessarily determine a causal relationship between an adverse 
event and the dietary supplement associated with the event. Appendix II 
provides further detail on adverse event reports related to dietary 
supplements received by FDA from January 1, 2003 through August 6, 
2008. 

Table 2: Number of Cases with Mandatory Reported Adverse Event Outcomes 
by Dietary Supplement Product Classification, from December 22, 2007, 
through October 31, 2008: 

Dietary supplement product classification: Combination products and 
products not elsewhere classified; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 391; 
Percentage of all serious adverse events reported: 65.6%. 

Dietary supplement product classification: Vitamin; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 240; 
Percentage of all serious adverse events reported: 40.3%. 

Dietary supplement product classification: Mineral; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 111; 
Percentage of all serious adverse events reported: 18.6%. 

Dietary supplement product classification: Fats and lipid substances; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 55; 
Percentage of all serious adverse events reported: 9.2%. 

Dietary supplement product classification: Herbal and botanical (other 
than tea); 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 24; 
Percentage of all serious adverse events reported: 4.0%. 

Dietary supplement product classification: Fiber; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 20; 
Percentage of all serious adverse events reported: 3.4%. 

Dietary supplement product classification: Herbal and botanical teas; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 15; 
Percentage of all serious adverse events reported: 2.5%. 

Dietary supplement product classification: Protein; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 9; 
Percentage of all serious adverse events reported: 1.5%. 

Dietary supplement product classification: Animal by-products and 
extracts; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 1; 
Percentage of all serious adverse events reported: 0.2%. 

Dietary supplement product classification: Total; 
Number of serious adverse events reported, from December 22, 2007, 
through October 31, 2008: 596[A]. 

Source: FDA. 

[A] Total does not add because some adverse event reports involved more 
than one product and are counted in more than one subcategory. For 
example, according to FDA, if a consumer was taking both a vitamin C 
supplement and an echinacea supplement when the adverse event took 
place, the event would be classified under both "vitamin" and "herbal 
and botanical." If the consumer was taking a single product containing 
both vitamin C and echinacea, the event would be classified under 
"combination products." 

[End of table] 

Although FDA has received a greater number of reports since mandatory 
reporting requirements went into effect, FDA recently estimated that 
the actual number of total adverse events--including serious, moderate, 
and mild--related to dietary supplements per year is over 50,000. 
[Footnote 3] This estimate suggests that underreporting of adverse 
events limits the amount of information that FDA receives regarding 
safety concerns related to dietary supplements or their ingredients 
and, according to FDA, this can negatively impact the agency's ability 
to identify safety concerns. 

Experts have cited several possible reasons for underreporting related 
to dietary supplements, including reduced attribution of adverse 
effects to supplements due to the assumption that all dietary 
supplements are safe, the reluctance of consumers to report dietary 
supplement use to physicians, the failure to recognize chronic or 
cumulative toxic effects from their use, and a cumbersome reporting 
process. To facilitate adverse event reporting for any FDA-regulated 
products, FDA is currently developing MedWatchPlus, an interactive Web- 
based portal intended to simplify the reporting process and reduce the 
time and cost associated with reviewing paper reports. For example, 
according to FDA planning documents, MedWatchPlus would simplify the 
reporting process by providing a single Internet portal for consumers, 
health care providers, and industry to report an adverse event. 
Furthermore, the proposed interactive format will prompt reporters to 
provide relevant information based on the type of products involved in 
the adverse event--thereby facilitating reporting and improving the 
quality of information FDA receives. Once an event is reported, the 
information would be automatically routed to the relevant FDA centers 
based on the type of product involved. Testing and release of the 
interactive questionnaire phase of the project is currently expected in 
2009. 

Although FDA Has Taken Some Steps to Identify and Act on Concerns about 
the Safety of Dietary Supplements, Several Factors Limit Its Oversight: 

FDA has taken some steps--such as analyzing adverse event reports and 
detaining certain potentially unsafe imported products--to identify and 
act upon safety concerns related to dietary supplements. However, 
several factors limit the agency's ability to detect concerns and 
efficiently and effectively remove products from the market. For 
example, FDA has limited information on the number and location of 
dietary supplement firms, the identity and ingredients of products 
currently available in the marketplace, and mild and moderate adverse 
events reported to industry. Additionally, FDA dedicates relatively few 
resources to dietary supplement oversight activities compared with 
other FDA-regulated products. Moreover, once the agency has identified 
a safety concern, the agency's ability to efficiently and effectively 
remove a product from the market is hindered by a lack of mandatory 
recall authority and the difficulty of establishing adulteration for 
dietary supplement products under the significant or unreasonable risk 
standard. Although FDA has taken some steps, such as drafting guidance 
for industry on reporting serious adverse events and establishing its 
Current Good Manufacturing Practice regulations, to improve the 
oversight of dietary supplements over the past several years, consumers 
remain vulnerable to risks posed by potentially unsafe products. 

FDA Has Taken Some Actions to Identify and Act on Concerns about the 
Safety of Dietary Supplements: 

FDA uses a variety of approaches to identify potential safety concerns 
related to dietary supplements. For example, FDA may identify concerns 
through surveillance actions such as monitoring adverse event reports 
and consumer complaints, screening imports, and conducting inspections. 
For instance, during almost half of the 909 inspections conducted at 
dietary supplement firms from fiscal year 2002 through May 6, 2008, FDA 
and its partners at the state level identified potential problems, such 
as a lack of quality control and unsanitary conditions. Table 3 
provides examples of FDA surveillance related to dietary supplements. 
For more detailed information on FDA's actions to identify potential 
safety concerns, see appendix II. 

Table 3: Examples of FDA Surveillance to Identify Safety Concerns: 

Surveillance action: Monitoring adverse events; 
FDA received 3,502 adverse event reports related to dietary supplements 
from January 1, 2003 through October 31, 2008. The top three outcomes 
associated with these cases were hospitalization (32 percent), 
nonserious illness or injury (28 percent), and serious illness or 
injury (25 percent).[A] 

Surveillance action: Monitoring consumer complaints; 
FDA received 1,018 consumer complaints from fiscal year 2001 through 
July 3, 2008. Forty-two percent of these complaints involved adverse 
symptoms. Consumer complaints involving adverse symptoms triggered 236 
active surveillance operations, including inspections and sample 
collections. 

Surveillance action: Screening imports; 
FDA reviewed 616,464 import entry lines of dietary supplements from 
fiscal year 2002 through March 24, 2008, and either sampled or 
examined, on average, approximately 3 to 5 percent of the imported 
entry lines entering the country.[B] 

Surveillance action: Conducting inspections; 
FDA conducted 804 inspections, and state partners conducted 105 
inspections, of domestic dietary supplement firms from fiscal years 
2002 through 2008. Investigators identified potential problems, such as 
a lack of quality control and unsanitary conditions, in 49 percent of 
these inspections. 

Source: GAO analysis of FDA data. 

[A] An adverse event report case may have more than one reported 
outcome. 

[B] According to FDA, an entry line is each portion of an import 
shipment that is listed as a separate item on an entry document. Items 
in an import entry having different tariff descriptions must be listed 
separately. 

[End of table] 

In addition, FDA monitors the Internet to identify products that 
purport to be dietary supplements but may be fraudulently promoted for 
treating diseases. According to FDA, such products pose a threat to 
public health because the disease prevention and treatment claims often 
persuade consumers to delay or forgo medical diagnosis and treatment. 
FDA officials also told us they identify safety concerns by obtaining 
information from other agencies at the state, federal, and 
international level; reviewing scientific literature; sponsoring safety-
related research; and targeting safety-related investigations on 
particular classes of products. For instance, according to FDA, the 
agency used adverse event information from the Florida Department of 
Health to issue a consumer warning about the product "Total Body 
Formula." FDA officials also described current safety-related 
investigations it initiated targeting specific classes of products, 
such as ephedra substitutes; male potency enhancers that contain 
undeclared active pharmaceutical ingredients; and products making 
misleading health claims to prevent or cure serious illnesses such as 
diabetes, sudden acute respiratory syndrome, and influenza. For 
example, officials said they are currently contracting with the 
University of California at Los Angeles to monitor adverse event 
reporting related to ephedra substitutes. In addition, FDA is 
conducting animal testing through the National Center for Toxicological 
Research to examine interactions among weight loss supplement 
ingredients, according to agency officials. 

Once FDA has identified a potential safety concern, the agency has 
several options available for taking action. According to FDA 
officials, products or ingredients of greatest concern for public 
health generally will be subject to either administrative or judicial 
enforcement actions, whereas FDA will take advisory actions against 
products of lower public health risk. FDA officials also noted that, if 
a firm does not correct violations in response to an advisory action, 
FDA may pursue an enforcement action against the firm. Table 4 provides 
examples of FDA administrative and enforcement actions related to 
dietary supplements. For more detailed information on FDA's actions in 
response to identified safety concerns, see appendix II. 

Table 4: Examples of FDA Actions in Response to Identified Safety 
Concerns: 

Advisory action: Hold regulatory meeting with the firm; 
FDA officials may meet with firm representatives to discuss concerns 
and request voluntary action; however, FDA does not collect agencywide 
data on these meetings. 

Advisory action: Issue firm a warning; 
FDA issued 293 warning letters citing 534 violations regarding dietary 
supplements from fiscal years 2002 through 2007. Seventy percent of 
these violations related to dietary supplements that FDA determined 
were either unapproved new drugs or misbranded drugs. 

Advisory action: Issue consumer alerts; 
FDA had posted 12 consumer alerts on its Web site since 1999, including 
warnings for kava, aristolochic acid, and St. John's wort, among 
others, as of November 21, 2008. 

Advisory action: Issue advisory to industry; 
FDA had posted letters to industry advising against the marketing of 
products containing aristolochic acid, comfrey, androstenedione, 
Lipokinetix, and ephedra, as of November 21, 2008. 

Administrative and judicial enforcement actions to remove a product 
from the market: Work with company on a voluntary product recall; 
At least 45 recalls related to dangerous or defective dietary 
supplement products that posed a serious health concern were initiated 
from fiscal years 2003 through 2008. Of these recalls, 27 were due to 
the unapproved presence of pharmaceutical ingredients in the supplement 
products. 

Administrative and judicial enforcement actions to remove a product 
from the market: Detain/refuse the product if imported; 
FDA detained 3,225 dietary supplement import entry lines from fiscal 
year 2002 through March 24, 2008. Fifty percent of the detentions were 
due to the potential presence of a poisonous or unsafe substance. Over 
this same period, FDA refused 3,604 lines of dietary supplements, 
citing 5,560 violations. Twenty-five percent of the violations were due 
to the potential presence of an unsafe substance. 

Administrative and judicial enforcement actions to remove a product 
from the market: Pursue legal action against the firm; 
FDA initiated action for 27 seizures and 6 injunctions from fiscal year 
2002 through July 18, 2008. Nineteen of the seizures and 6 of the 
injunctions regarded products promoted to treat, cure, or prevent 
diseases. FDA had filed criminal charges or won convictions in 19 cases 
since fiscal year 2002, as of July 31, 2008. 

Administrative and judicial enforcement actions to remove a product 
from the market: Ban ingredient; 
FDA banned one ingredient--ephedra--in 2004, almost 10 years after 
issuing its first advisory. FDA has not banned any other dietary 
supplement ingredients. 

Source: GAO analysis of FDA data. 

[End of table] 

In addition to taking enforcement action on its own, FDA may pursue 
enforcement action in conjunction with another federal agency, such as 
the Federal Trade Commission, which has enforcement responsibility with 
regard to dietary supplement advertising. For example, as part of the 
FDA's Consumer Health Information for Better Nutrition initiative 
launched in 2002, FDA and the Federal Trade Commission took joint 
enforcement actions against several marketers of dietary supplement 
products making unsubstantiated treatment claims for diseases such as 
emphysema, diabetes, Alzheimer's disease, cancer, and multiple 
sclerosis. In addition, industry has also initiated some measures to 
address unsubstantiated claims. For example, based on monitoring 
efforts and company referrals, the National Advertising Division of the 
Council of Better Business Bureaus reviews advertising claims for 
accuracy and then recommends changes to companies as necessary. This 
program is currently funded through a series of multiyear grants from 
the Council for Responsible Nutrition. 

FDA officials also noted that the agency plans to expand dietary 
supplement oversight in the near term. In particular, FDA will add 
dietary supplement inspections as an option for its formal state 
contract agreements in 2009, which should increase the number of 
dietary supplement inspections performed by state officials on FDA's 
behalf, according to FDA officials.[Footnote 4] To further increase the 
number of inspections, FDA is also exploring third-party certification 
as part of its Food Protection Plan: An Integrated Strategy for 
Protecting the Nation's Food Supply.[Footnote 5] To improve the 
agency's Internet surveillance, FDA has plans to implement a 
sophisticated computer program that will search the Web for 
unauthorized disease treatment claims, potentially searching hundreds 
of thousands of Web sites per minute compared with a manual search by 
FDA staff, according to an FDA official. Moreover, although agency 
officials stated it was too early to determine the effectiveness of the 
newly established Current Good Manufacturing Practice regulations and 
serious adverse event reporting requirements, these new tools could 
improve the agency's ability to oversee the dietary supplement 
industry. While several stakeholders generally agreed that the new 
regulations could improve FDA's ability to oversee the dietary 
supplement industry, some stakeholders raised concerns about FDA's 
ability to enforce the new requirements given its limited resources. 

Several Factors Limit FDA's Ability to Identify and Act on Safety 
Concerns Related to Dietary Supplements: 

Although FDA has taken some steps to identify and act on safety 
concerns, limited information hinders FDA's oversight of the dietary 
supplement industry. In addition, FDA dedicates relatively few 
resources to dietary supplement oversight. Furthermore, FDA is limited 
by a lack of authority to efficiently and effectively remove products 
from the market. 

FDA's Ability to Identify Safety Concerns Is Hindered by a Lack of 
Information: 

FDA's ability to identify safety concerns is hindered by a lack of 
information in three key areas: the identity and location of dietary 
supplement firms; the types and contents of products on the market; and 
product safety information, such as adverse event data. First, FDA 
lacks complete information on the names and location of dietary 
supplement firms within the agency's jurisdiction. Although all dietary 
supplement firms must register with FDA as food facilities to provide 
information on their name and location, firms specializing in certain 
product categories, such as herbal products, are not required to self- 
identify as dietary supplement firms under current law. For example, a 
firm manufacturing products containing only herbs, such as echinacea 
and ginseng, would not be required to identify itself as a dietary 
supplement firm during the registration process. Consequently, FDA may 
not be aware of all dietary supplement firms that are currently 
operating. In addition, there is little assurance that FDA's existing 
inventory of dietary supplement firms is accurate because this 
information is not updated in a systematic fashion. As one FDA official 
explained, a thorough review of FDA's firm inventory would probably 
require dedicating 10 to 15 staff within each field office to the task 
for a year--which is unlikely given FDA's current workload. However, 
FDA officials did indicate that modifying the existing registration 
categories to better reflect FDA's inspection responsibilities could 
provide the agency with more complete information on the number and 
location of dietary supplement firms within its regulatory 
jurisdiction, provided industry complies with the new requirements. In 
FDA's Food Protection Plan, the agency requested statutory changes to 
allow modifying existing registration categories and require biannual 
renewals for food facilities, stating that such changes would ensure 
FDA has accurate, up-to-date information and would help the agency 
assess and respond to potential threats to the food supply. 

Second, FDA does not have comprehensive information on the types and 
contents of dietary supplement products that are on the market or their 
ingredients. In addition, FDA officials noted that, if a dietary 
supplement firm reformulates a product to include different ingredients 
and/or changes the amounts of the ingredients without renaming the 
product, FDA may not be aware of the changes. Although drug 
manufacturers are required by law, with some exceptions, to register 
the identity and active ingredients of their products with FDA, the 
agency lacks the authority to require similar product information from 
dietary supplement manufacturers. Detailed product information could 
help the agency more efficiently and effectively analyze the adverse 
event reports it receives. For example, according to FDA, voluntary 
reports often contain inaccurate or incomplete information on product 
ingredients. Complete information on product ingredients could help the 
agency establish links between mandatory and voluntary reports on 
products containing the same ingredient. Furthermore, a database of 
marketed products and their ingredients could help the agency respond 
more quickly to safety concerns. For instance, if FDA identified a 
particular ingredient of concern, officials could quickly determine 
which products on the market contained the ingredient and tailor the 
agency's response accordingly. 

Third, FDA's ability to identify safety concerns is undermined by a 
lack of information on product safety, such as data on the frequency 
and characteristics of adverse events related to dietary supplements. 
As we noted earlier in this report, although dietary supplement firms 
are required to report all serious adverse event reports they have 
received to FDA, they are not required to report mild or moderate 
adverse events.[Footnote 6] Additional information on adverse events 
could be particularly beneficial because there is a limited amount of 
scientific data available on the safety of dietary supplements compared 
with other regulated products such as drugs, which require premarket 
approval. For instance, FDA officials noted that mandatory reporting of 
mild and moderate events could assist the agency by increasing the 
amount of data available for signal detection, as well as provide 
additional support for safety-related conclusions regarding particular 
products or ingredients. Although some stakeholders have pointed out 
that mandatory manufacturer reporting of mild and moderate events won't 
fully address the issue of underreporting--particularly for consumers 
and health care providers--most medical researchers we interviewed 
agreed that mandatory reporting of all adverse events would be 
beneficial to the agency. 

FDA Dedicates Relatively Few Resources to Dietary Supplement Oversight: 

FDA dedicates relatively few resources to dietary supplement oversight 
activities, including conducting inspections and developing guidance 
for industry on key safety-related aspects of DSHEA. Our analysis of 
FDA expenditure data found that FDA dedicated approximately 4 percent 
of CFSAN resources and 1 percent of its field resources--which are 
dedicated to FDA's Office of Regulatory Affairs--to dietary supplement 
programs from fiscal years 2006 through 2007.[Footnote 7] FDA uses its 
field resources to, for example, monitor industry compliance by 
conducting surveillance actions such as inspections and import 
screenings. As FDA officials explained, limited inspection resources 
are prioritized according to public health risk, and dietary 
supplements are generally considered to be a lesser risk than, for 
example, foods that could be contaminated with foodborne pathogens. 
Consequently, although FDA conducted 973 inspections of foreign food 
firms from fiscal year 2002 through fiscal year 2008, FDA conducted no 
foreign inspections of dietary supplement firms during this time 
period.[Footnote 8] Similarly, although FDA increased the number of 
domestic inspections of dietary supplement firms in fiscal years 2004 
and 2005, overall, these inspections represented less than 1 percent of 
total food establishment inspections conducted by FDA and its state 
partners from fiscal years 2002 through 2008. With few resources 
dedicated to dietary supplement inspections, FDA's ability to identify 
potential safety concerns through this key surveillance activity is 
limited. 

Furthermore, despite identifying the need to provide industry with 
guidance on key aspects of DSHEA, FDA has not done so in a timely 
manner. For example, DSHEA authorized FDA to establish Current Good 
Manufacturing Practices specific to dietary supplements in 1994; 
however, the agency did not publish a proposed rule until 2003 and did 
not finalize the rule until 2007. FDA officials noted that it first 
issued an advance notice of proposed rulemaking in 1997 and went 
through a number of steps, such as conducting public meetings, to 
develop an overall strategy for regulating dietary supplements and then 
submitted its rule to the Office of Management and Budget for clearance 
before finalizing the rule. Because these Current Good Manufacturing 
Practices are phased in over time, they will not fully be in effect 
until 2010--16 years after FDA was authorized to establish them. 

In addition, although FDA recognized the need to develop guidance on 
the new dietary ingredient provisions of DSHEA, FDA has yet to issue 
this guidance--an omission previously highlighted in our 2000 report. 
As an FDA official explained, new dietary ingredient guidance is 
critical for dietary supplement safety because, without formal 
guidance, firms may not notify FDA before marketing products that have 
drastically different safety profiles than their historical use. For 
example, this official was concerned that a firm could use bitter 
orange's historical use as a flavoring in marmalade as justification 
for not submitting a new dietary ingredient notification to FDA when it 
uses bitter orange to create a product that is 95 percent synephrine-- 
a powerful stimulant. Similarly, a firm might choose to market dietary 
supplement products that contain nano-sized particles of grandfathered 
ingredients without notifying FDA in advance. According to the FDA 
official, this raises concerns because potential health risks 
associated with nano-sized particles are unknown. According to this 
official, FDA has started to develop draft guidance for new dietary 
ingredients that would clarify what factors FDA will use when 
determining if a substance is a new dietary ingredient. More 
specifically, the guidance would clarify what changes to grandfathered 
ingredients would require a new dietary ingredient notification to FDA 
and what information should be included in the notification, among 
other items. However, this draft guidance has been under legal review 
for over a year, and FDA did not provide us with a time frame for its 
issuance. 

FDA's Lack of Authority Limits Its Ability to Remove Products from the 
Market: 

Once FDA has identified a safety concern, the agency's ability to 
efficiently and effectively remove a product from the market is 
hindered by a lack of mandatory recall authority. For instance, FDA 
officials commented that FDA's ability to protect consumers through its 
voluntary recall authority is limited because it relies on industry 
exercising its responsibility rather than enforceable requirements. As 
FDA noted in its Food Protection Plan, mandatory recall authority would 
allow the agency to ensure the prompt and complete removal of unsafe 
products from distribution channels in cases where a firm was unwilling 
to cooperate voluntarily. 

Additionally, agency officials and other stakeholders have acknowledged 
the difficulty of banning a dietary supplement because FDA must 
establish adulteration under the significant or unreasonable risk 
standard. For example, it took FDA almost 10 years after issuing its 
first advisory about ephedra to gather sufficient data to meet the 
statutory burden of proof for banning ephedra from the market. The 
difficulty of establishing significant or unreasonable risk is 
compounded by limited scientific research on the safety of dietary 
supplements--which are generally presumed safe under the law, and firms 
are not required to provide FDA with evidence of product safety for 
ingredients marketed prior to October 15, 1994, such as ephedra. 
Underreporting of adverse events also limits FDA's ability to meet its 
burden of proof. In the case of ephedra, one firm withheld information 
from FDA on thousands of serious adverse event reports related to its 
product--which hindered FDA's investigation, and prompted support for 
establishing mandatory reporting requirements. As previously mentioned 
in this report, although mandatory serious adverse event reporting 
requirements for industry are now in effect, underreporting of all 
adverse events from consumers, health care providers, and industry 
remains a concern. According to an agency official, given these data 
limitations and the agency's difficult and costly experience with 
ephedra, banning an ingredient is not a very viable option. However, 
according to some experts, the difficult process of establishing 
significant or unreasonable risk for dietary supplement ingredients 
with known safety concerns has raised doubts about FDA's ability to 
adequately protect the public. For example, table 5 summarizes FDA 
actions for certain dietary supplement ingredients that have been 
banned in other countries. 

Table 5: Examples of FDA Actions Taken on Dietary Supplement 
Ingredients That Have Been Banned in Other Countries: 

Ingredient: Aristolochic acid; 
Reported uses: Aphrodisiac, immune stimulant; 
Dangers: Kidney damage, cancers, deaths reported; 
Regulatory actions in other countries: Banned in seven European 
countries, Japan, Venezuela, and Egypt; 
FDA actions: In 2000 and 2001, FDA listed aristolochic acid as a 
"Botanical Ingredient of Concern" and issued letters to industry and 
health care professionals. In 2001, FDA issued an "Import Alert" for 
products containing the ingredient and issued a consumer advisory. FDA 
has also taken some enforcement or advisory actions against individual 
products. 

Ingredient: Kava; 
Reported uses: Anxiety, stress; 
Dangers: Abnormal liver function or damage, deaths reported; 
Regulatory actions in other countries: Banned in Canada, Germany, 
Singapore, South Africa, and Switzerland; 
FDA actions: FDA issued letters to health care professionals in 2001 
and 2002 and a consumer advisory in 2002. 

Ingredient: Lobelia; 
Reported uses: Asthma, bronchitis; 
Dangers: Tremor, overdose may cause coma and possibly death; 
Regulatory actions in other countries: Banned in Bangladesh and Italy; 
FDA actions: No action. 

Source: GAO analysis of FDA and Consumer's Union data. 

Note: GAO did not independently verify regulatory actions in other 
countries. 

[End of table] 

While FDA Has Taken Some Actions When Foods Contain Unsafe Dietary 
Ingredients, Certain Factors May Allow Unsafe Products to Reach 
Consumers: 

Although FDA has taken some actions, such as issuing warnings, when 
foods contain unsafe dietary ingredients, certain factors may allow 
unsafe products to reach consumers. FDA may not know when a company has 
made an unsupported or incorrect GRAS determination about an added 
dietary ingredient in a product until after the product becomes 
available to consumers because companies are not required to notify FDA 
of their self-determinations. In addition, the boundary between dietary 
supplements and foods containing added dietary ingredients is not 
always clear, and some food products could be marketed as dietary 
supplements to circumvent the safety standard required for food 
additives. Finally, according to FDA officials, the agency conducts a 
limited amount of monitoring for safety concerns associated with foods 
containing added dietary ingredients. 

Companies Are Not Required to Notify FDA When They Make a Self- 
Determination That an Added Ingredient Is GRAS: 

The Federal Food, Drug, and Cosmetic Act allows companies to market a 
conventional food product with added dietary ingredients if the company 
determines that the added dietary ingredient meets the GRAS standard. 
These companies do not have to notify FDA before selling the product to 
consumers, although some may do so voluntarily. If a company makes an 
unsupported or incorrect GRAS determination about an added dietary 
ingredient in a product, FDA may not know about the product until after 
it becomes available to consumers. This was the case, for example, for 
several food products containing such herbs as kava, ginkgo, and 
echinacea. Specific examples are as follows: 

* In 2004, during a food inspection of a juice company, FDA found that 
the company was marketing a product that contained kava. According to 
FDA, it is not aware of a basis for concluding that kava is GRAS, and 
it has not approved kava as a food additive. In addition, kava was the 
subject of a public health advisory issued by FDA in March 2002, which 
warned consumers of the potential risk of severe liver injury 
associated with the use of kava. 

* In 2001, FDA identified a company marketing cereals with ginkgo 
biloba and Siberian ginseng. According to FDA, it is not aware of a 
basis for concluding that these ingredients are GRAS, and it has not 
approved them as food additives. FDA sent a warning letter to the 
company, and the product was subsequently removed from the market. 

* Also in 2001, FDA identified a company marketing juices with added 
echinacea. FDA sent a warning to the company noting that it has not 
approved echinacea as a food additive and is not aware of a basis for 
concluding that echinacea is GRAS. 

FDA learned of these products after they were available to consumers. 
If FDA wanted to remove these products from the market, and the 
companies did not do so voluntarily, FDA would have to initiate 
enforcement actions. 

The Boundary between Dietary Supplements and Foods with Added Dietary 
Ingredients Is Not Always Clear: 

The boundary between dietary supplements and foods containing added 
dietary ingredients is not always clear. FDA officials have noted, for 
example, that a tea with an identical mix of herbal ingredients could 
be considered either a dietary supplement or a food product. FDA 
determines how to classify the tea based on the product labeling. More 
specifically, according to FDA, if the tea is labeled as a dietary 
supplement and is not represented as a conventional food, FDA would 
consider the tea to be a dietary supplement and regulate it as such. On 
the other hand, if the tea is labeled as a food or is represented as a 
conventional food with terms such as "drink" or "beverage," FDA 
officials noted that they would consider the tea to be a food. 

The way FDA classifies a product is important because the safety 
standard that applies to the product varies based on that 
classification. If the product is classified as a conventional food, 
the added dietary ingredient must meet the GRAS standard or be approved 
by FDA as a food additive, except in certain circumstances as 
authorized in law. If the product is classified as a dietary 
supplement, the added dietary ingredient is presumed safe if it was 
marketed in the United States before October 15, 1994; otherwise, it is 
considered a new dietary ingredient, and the manufacturer or 
distributor may be required to notify FDA 75 days before the product 
with the added dietary ingredient enters the market and provide some 
basis for concluding that the ingredient is reasonably expected to be 
safe. According to FDA and industry officials, this is a less stringent 
standard than that for food additives. However, FDA does not have the 
authority to require that the safety of dietary supplements be approved 
before entering the market. 

These differences in how products are regulated may lead to 
circumstances when an ingredient would not be allowed to be added to a 
product if it was labeled as a conventional food but would be allowed 
in the identical product if it was labeled as a dietary supplement. 
This was the case, for example, in August 2007, when FDA identified a 
company marketing an iced tea mix containing stevia--an herb that had 
not been approved as a food additive because of potential safety 
concerns, including reproductive and cardiovascular effects. FDA issued 
a warning to the company; however, rather than discontinue using stevia 
in its product, the company changed the label to classify the product 
as a dietary supplement rather than a food, and the product remains on 
the market. We identified other products that also fall within the gray 
area between dietary supplements and foods with added dietary 
ingredients that are being marketed as dietary supplements. For 
example, we identified several nutrition bars, teas, and energy drinks, 
some produced by large companies with national distribution, which 
contain herbs such as kava, St. John's wort, and echinacea. If these 
ingredients are added to conventional foods and are not GRAS and have 
not been approved as food additives, then they would violate the 
Federal Food, Drug, and Cosmetic Act. An FDA official told us that FDA 
is unaware of a basis for concluding that these ingredients are GRAS, 
and they have not been approved as food additives. However, these 
products may remain on the market because they are labeled as dietary 
supplements. Such a process might allow companies to circumvent the 
safety standard required for food additives. 

In FDA's 10-year plan to implement DSHEA, issued in January 2000, the 
agency identified the need to clarify the boundary between conventional 
foods and dietary supplements but did not indicate when or how the 
agency planned to address this issue. Moreover, we highlighted this 
particular issue in our July 2000 report and recommended FDA take 
action to clarify the boundary between conventional foods and dietary 
supplements. As of November 2008, the agency had not issued regulations 
or guidance to clarify this boundary. 

FDA Conducts Limited Monitoring of Foods with Added Dietary 
Ingredients: 

According to FDA officials, the agency conducts limited monitoring for 
safety concerns associated with food products that contain added 
dietary ingredients. These officials explained that FDA does not track 
these products separately from foods, and the agency generally relies 
on trade complaints and adverse event reports to identify concerns 
about these types of products. FDA officials told us that the current 
regulatory framework is sufficient to identify and act on safety 
concerns regarding foods with added dietary ingredients. FDA held a 
public meeting in 2006 regarding these products and, according to FDA 
officials, the agency is currently evaluating the comments made during 
that meeting. 

Some stakeholders told us that safety risks associated with foods 
containing added dietary ingredients that meet the GRAS standard or 
have been approved as food additives are generally low. For example, 
stakeholders were generally not concerned about vitamin-fortified 
products, such as cereal, unless individuals consume these products in 
high doses. However, some stakeholders we spoke with raised concerns 
about certain products--such as energy drinks that contain stimulants 
and have the potential to cause adverse cardiac effects. In addition, 
some stakeholders expressed concern about adding botanicals to foods 
due, in part, to the potential for an adverse physiological response. 
In contrast, an industry official noted that companies sometimes add 
dietary ingredients to foods for labeling or marketing purposes--not to 
elicit a physiological effect--and, therefore, the amounts included are 
low. 

FDA Has Taken Limited Steps to Educate Consumers about Dietary 
Supplements, and Consumers Remain Largely Uninformed: 

While FDA has conducted some consumer outreach, these initiatives have 
reached a relatively small proportion of consumers using dietary 
supplements. Additionally, surveys and experts indicate that consumers 
are not well-informed about the safety and efficacy of dietary 
supplements and have difficulty interpreting labels on these products. 
Without a clear understanding of the safety, efficacy, and labeling of 
dietary supplements, consumers may be exposed to greater health risks 
associated with the uninformed use of these products. 

FDA Has Conducted Some Consumer Education about Dietary Supplements, 
but these Efforts Have Been Limited: 

FDA has taken some steps to educate consumers about the safety, 
efficacy, and labeling of dietary supplements. According to FDA 
officials, the agency primarily educates the public about dietary 
supplements through publications such as brochures and articles, as 
well as the agency's Web site. For example, agency officials 
highlighted the following efforts: 

* FDA and the NIH's Office of Dietary Supplements jointly published a 
brochure in 2004 to educate consumers about the importance of 
disclosing their dietary supplement usage to doctors. 

* In March 2006, FDA developed a document entitled, "Food Facts: 
Dietary Supplements--What You Need to Know" with general information 
about dietary supplements. 

* In August 2008, FDA distributed an article via e-mail and its Web 
site entitled "FDA 101: Dietary Supplements" that contained information 
on the regulation of dietary supplements, as well as information on the 
safety, efficacy, and labeling of these products. 

* FDA's Web site provides warnings about certain ingredients and 
products, how to report an adverse event, and general consumer 
information about dietary supplements, including descriptions of the 
types of label claims permitted on dietary supplement products. FDA's 
Web site also links consumers to the NIH, Federal Trade Commission, 
United States Department of Agriculture, and National Academies' 
Institute of Medicine Web pages that contain information about the 
safety and efficacy of certain dietary supplement ingredients and how 
to interpret dietary supplement labels. 

* FDA has worked jointly with industry, consumer groups, and other 
federal agencies to provide consumers with information about label 
claims. 

However, these outreach efforts can only be as effective as the number 
of dietary supplement users they reach. While data from the 2007 
National Health Interview Survey show that over half of the U.S. adult 
population--or at least 114 million individuals--consume dietary 
supplements, we found that FDA's outreach efforts have limited 
potential to reach the majority of U.S. adults using dietary 
supplements. For example, according to FDA and NIH officials, since 
2004, the brochure regarding disclosure of supplement use to doctors 
had a distribution of 40,000 paper copies and received about 171,000 
total visits on the FDA and NIH Web sites--which represent less than 1 
percent of estimated dietary supplement users. Other FDA publications 
on dietary supplements have also reached a relatively small proportion 
of dietary supplement consumers. For example, according to FDA 
officials, it distributed about 61,000 English copies and approximately 
35,000 Spanish copies of its document entitled "Food Facts: Dietary 
Supplements--What You Need to Know." In addition, according to FDA 
officials, its consumer article on dietary supplements called "FDA 101: 
Dietary Supplements" was sent via e-mail to almost 32,500 subscribers 
to FDA's "Consumer Health Information" and, as of October 21, 2008, 
FDA's Web site had logged about 3,800 page views of the HTML version 
and approximately 2,100 page views of the printer-friendly PDF of the 
article. 

While agency officials stated that FDA does not evaluate the 
effectiveness of its outreach efforts, officials also noted that the 
agency must continually market its desired messages to effectively 
educate consumers. Additionally, consumer education was highlighted as 
an important part of the agency's 10-year plan for dietary supplements, 
published in 2000. In the November 2004 update to this plan, FDA 
identified the need to provide consumers with access to reliable 
scientific information about the safety of ingredients and supplements 
so that consumers may make more informed choices. Currently, according 
to FDA, CFSAN has no ongoing or new consumer education initiatives 
being planned for dietary supplements. FDA recently announced a 
partnership with WebMD to expand consumer access to timely and reliable 
health information; however, it is not clear to what extent FDA will 
use this partnership to increase consumer understanding about dietary 
supplements. When asked about plans for consumer education initiatives, 
FDA officials explained that the agency has been directing its limited 
resources toward activities that can have the greatest public health 
impact, such as responding to foodborne illness outbreaks. 

Consumers Are Not Well-Informed about the Safety, Efficacy, and 
Labeling of Dietary Supplements: 

Several studies indicate that consumers are not well-informed about the 
safety, efficacy, and labeling of dietary supplements. For example, a 
2002 Harris Poll indicated that a majority of adults are misinformed 
about the extent to which government regulates the safety of vitamins, 
minerals, and food supplements. According to the poll, over half of 
respondents believed that dietary supplements are approved by a 
government agency. A 2002 FDA-sponsored health and diet survey also 
estimated that a majority of respondents who used vitamin or mineral 
supplements believed that the government approves dietary supplement 
products before they are marketed to consumers. However, FDA does not 
have the authority to require that supplements be approved for safety 
and effectiveness prior to marketing, and, unless a product contains a 
new dietary ingredient, FDA does not need to be notified by the 
manufacturer prior to marketing a dietary supplement. Additionally, the 
2002 Harris Poll estimated that about two-thirds of respondents believe 
that the government requires dietary supplement labels to contain 
warnings about potential side effects, or dangers, similar to drugs. 
However, unlike drug manufacturers, who are required to include 
warnings related to adverse effects and contraindications on their 
product labels, dietary supplement manufacturers are required to 
include few such warnings on their product labels. Consequently, 
dietary supplement manufacturers may not necessarily include warnings 
about potential adverse effects on the labels of their products. For 
example, in the course of our review, we identified several dietary 
supplements that contained ingredients with known or suspected adverse 
effects, such as kava and black cohosh, that did not include warnings 
on their labels. In addition, in 2003, an analysis of 100 dietary 
supplement labels by the Department of Health and Human Services' 
Office of Inspector General found that the dietary supplement labels 
were limited in their ability to guide the informed and appropriate use 
of dietary supplements among consumers and often did not present 
information in a manner that facilitates consumer understanding. 
[Footnote 9] 

Furthermore, during the course of our review, most experts we spoke 
with noted that, generally, consumers are not well-informed about the 
safety and efficacy of dietary supplements. These experts explained 
that many consumers believe various myths about dietary supplements. 
For example, consumers may believe that if a product is natural, it 
must be safe; if a little is good, then more must be better; and if a 
product does not have a warning label, it must be safe. Without a clear 
understanding of the safety, efficacy, and labeling of dietary 
supplements, consumers are exposed to potential health risks associated 
with the uninformed use of these products. For example, several experts 
stated that misconceptions about dietary supplements could cause 
consumers to incorrectly assess the risks and benefits of these 
products and, in some cases, substitute supplements for prescribed 
medicine. In addition, several experts noted that consumers may not be 
aware that taking combinations of some supplements or using certain 
products in conjunction with prescription drugs could lead to harmful 
and potentially life-threatening results. In particular, some 
supplements--such as garlic, ginkgo biloba, ginseng, and vitamin E--may 
cause blood thinning and lead to life-threatening complications during 
surgical procedures. Therefore, consumer education is critical to 
mitigate the potential risks associated with the uninformed use of 
dietary supplements. 

Conclusions: 

Americans are widely interested in maintaining health and wellness and, 
with an aging population, we expect that consumers' interest in dietary 
supplements will continue to grow. These consumers confront an 
extensive variety of dietary supplements available in the marketplace, 
but little is known about the safety and efficacy of these products. 
Yet, most dietary supplements are presumed safe under current law, and 
companies do not need premarket approval for any dietary supplement. If 
FDA has concerns about a particular dietary supplement product or 
ingredient, the agency bears the burden of proof to require removal of 
the product from the market. In the case of ephedra--which was 
implicated in thousands of adverse events and a number of deaths--FDA 
faced a long and arduous process before finally banning the product in 
2004. 

At the same time, while more and more products are entering the market 
each year, FDA is dedicating a small percentage of its resources to 
regulating the dietary supplement industry and educating consumers 
about dietary supplements. FDA does not have comprehensive knowledge of 
dietary supplement manufacturers or the products on the market and has 
little information about potential side effects of various products. In 
addition, consumers are not well-informed about dietary supplements, 
may not be aware of potential side effects of supplements, and might 
not consider a dietary supplement as a factor if experiencing an 
adverse reaction. Weaknesses in the regulatory system may increase the 
likelihood of unsafe products reaching the market, and a lack of 
consumer knowledge increases the potential health risks associated with 
uninformed consumption. 

Recommendations for Executive Action: 

Overall, we are making four recommendations to enhance FDA's oversight 
of dietary supplements and foods with added dietary ingredients. 

1. To improve the information available to FDA for identifying safety 
concerns and better enable FDA to meet its responsibility to protect 
the public health, we recommend that the Secretary of the Department of 
Health and Human Services direct the Commissioner of FDA to request 
authority to require dietary supplement companies to: 

* identify themselves as a dietary supplement company as part of the 
existing registration requirements and update this information 
annually, 

* provide a list of all dietary supplement products they sell and a 
copy of the labels and update this information annually, and: 

* report all adverse events related to dietary supplements. 

2. To better enable FDA to meet its responsibility to regulate dietary 
supplements that contain new dietary ingredients, we recommend that the 
Secretary of the Department of Health and Human Services direct the 
Commissioner of FDA to issue guidance to clarify when an ingredient is 
considered a new dietary ingredient, the evidence needed to document 
the safety of new dietary ingredients, and appropriate methods for 
establishing ingredient identity. 

3. To help ensure that companies follow the appropriate laws and 
regulations and to renew a recommendation we made in July 2000, we 
recommend that the Secretary of the Department of Health and Human 
Services direct the Commissioner of FDA to provide guidance to industry 
to clarify when products should be marketed as either dietary 
supplements or conventional foods formulated with added dietary 
ingredients. 

4. To improve consumer understanding about dietary supplements and 
better leverage existing resources, we recommend that the Secretary of 
the Department of Health and Human Services direct the Commissioner of 
FDA to coordinate with stakeholder groups involved in consumer outreach 
to (1) identify additional mechanisms--such as the recent WebMD 
partnership--for educating consumers about the safety, efficacy, and 
labeling of dietary supplements; (2) implement these mechanisms; and 
(3) assess their effectiveness. 

Agency Comments and Our Evaluation: 

We provided a draft copy of this report to the Department of Health and 
Human Services for review and comment. We received a written response 
from the Acting Assistant Secretary for Legislation that included 
comments from FDA. FDA generally agreed with each of the report's 
recommendations and welcomed the report as a means of calling attention 
to the challenges FDA faces with respect to regulating dietary 
supplements and conventional foods formulated with added dietary 
ingredients. FDA noted that although receiving information on all 
adverse events related to dietary supplements could enhance FDA's 
ability to detect signals of potential toxicity over time, FDA raised 
concerns about its ability to efficiently and effectively analyze the 
information to identify unsafe dietary supplements. However, FDA stated 
that it is working on methodologies to mitigate this concern and 
improve data mining for safety-related signals if FDA were to receive 
all adverse event reports. In addition, FDA recognized the need for 
guidance to industry clarifying when products should be marketed as 
conventional foods or dietary supplements and stated that the agency 
will consider this recommendation and its implementation in light of 
FDA's limited resources and competing priorities. Furthermore, FDA 
noted that the agency's resources for consumer education are extremely 
limited and that it may not be able to effectively conduct consumer 
education on its own. FDA commented that collaborating with NIH's 
Office of Dietary Supplements may be an efficient and cost-effective 
way to expand FDA's current outreach activities. FDA also stated that 
the agency is identifying appropriate content for the recently 
announced FDA/WebMD partnership referenced in the report and 
anticipates that information on dietary supplements will be included. 
FDA's comments are presented in appendix IV of this report. FDA also 
provided technical comments on the draft report, which we incorporated 
as appropriate. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to the 
appropriate congressional committees; the Secretary of the Department 
of Health and Human Services; the Commissioner of FDA; the Director of 
the Office of Management and Budget; and other interested parties. The 
report also will be available at no charge on the GAO Web site at 
[hyperlink, http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff who made major contributions to 
this report are listed in appendix V. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

We were asked to examine the Food and Drug Administration's (FDA) 
oversight of dietary supplements and foods that contain added dietary 
ingredients. Specifically, we were asked to examine FDA's (1) actions 
to respond to the new serious adverse event reporting requirements; (2) 
ability to identify and act on concerns about the safety of dietary 
supplements; (3) ability to identify and act on concerns about the 
safety of foods with added dietary ingredients; and (4) actions to 
educate consumers about the safety, efficacy, and labeling of dietary 
supplements. Our work included dietary supplements for human use only. 
We did not assess FDA's regulation of dietary supplements for animal 
use. 

To identify FDA's actions to respond to the new serious adverse event 
reporting requirements, we reviewed FDA's guidance on reporting 
requirements for industry and internal procedures for compiling and 
tracking adverse event reports. In addition, we obtained and analyzed 
data on the number and type of reports received before and after the 
requirements went into effect. We verified our methodology for 
analyzing these data with FDA officials, and FDA verified our results. 
We also reviewed FDA's plans for improving adverse event reporting. 

To examine FDA's ability to identify and act on safety concerns 
associated with dietary supplements, we assessed FDA's laws, rules, 
regulations, planning documents and guidance, such as the Dietary 
Supplement Health and Education Act of 1994, Current Good Manufacturing 
Practice regulations, and guidance on reporting adverse events. In 
addition, we obtained and analyzed data on FDA's internal procedures 
and activities to identify safety concerns, such as conducting 
inspections and import screenings and receiving consumer complaints. We 
also obtained and analyzed FDA's internal procedures and data on the 
agency's actions once a safety concern is identified, including issuing 
warning letters, seizing products, and banning ingredients. We analyzed 
these data to determine the range and extent of actions FDA has taken 
to identify and act on safety concerns associated with dietary 
supplements. We verified our methodology for analyzing these data with 
FDA officials, and FDA verified our results. Furthermore, we reviewed 
data on FDA resources dedicated to dietary supplements. 

To examine FDA's ability to identify and act on concerns about the 
safety of foods with added dietary ingredients, we reviewed laws and 
regulations regarding food additives. In addition, we reviewed FDA's 
procedures for identifying and acting on safety concerns of foods with 
added dietary ingredients. We also identified and analyzed instances of 
actions taken by FDA to act on safety concerns associated with the 
addition of dietary ingredients to foods. 

To determine FDA's actions to educate consumers about the safety, 
efficacy, and labeling of dietary supplements, we reviewed FDA's 
consumer outreach initiatives. We also obtained and analyzed data on 
the extent to which these outreach initiatives were distributed. In 
addition, we analyzed data from FDA and others on consumer 
understanding of dietary supplements. 

To compare FDA's regulation of dietary supplements with select other 
countries' regulation of these products, we spoke with representatives 
from the governments of Canada, Japan, and the United Kingdom. In 
addition, we reviewed documents about the regulation of dietary 
supplements in these countries. We did not independently verify 
descriptions of foreign laws. We selected these countries because they 
had been identified in prior GAO work as having comparable food safety 
systems and covered a relatively diverse geographic area (Europe, North 
America, and Asia.) 

To assess the reliability of the data from FDA's databases used in this 
report, we reviewed related documentation, examined the data to 
identify obvious errors or inconsistencies, and worked with agency 
officials to identify any data problems. We determined the data to be 
sufficiently reliable for the purposes of this report. 

To obtain insights on all four objectives, we met with a wide range of 
experts, including officials from federal and state agencies, industry 
and trade organizations, consumer advocacy groups, academia, and poison 
control centers. Through these efforts, we obtained documents and 
information related to all four objectives. At the federal level, we 
met with officials from FDA, including headquarters and regional and 
district level officials, to discuss the agency's regulatory 
authorities, actions taken to implement the mandatory adverse event 
reporting system, steps taken to regulate the safety of dietary 
supplements and foods with added dietary ingredients, and consumer 
education responsibilities and actions. In addition, we met with 
officials from the National Institutes of Health, Federal Trade 
Commission, and Department of Agriculture. At the state level, we met 
with officials from the California Department of Public Health's Food 
and Drug Branch and Environmental Protection Agency and the New York 
State Task Force on Life and the Law. To obtain insights from the 
dietary supplement and food industries, we met with officials from the 
American Beverage Association, American Herbal Products Association, 
Consumer Healthcare Products Association, Council for Responsible 
Nutrition, Grocery Manufacturers Association, National Advertising 
Division of the Council of Better Business Bureaus, and Natural 
Products Association. In addition, we met with officials from a large 
dietary supplement manufacturer in Maryland, a multinational food and 
consumer products firm, and two small, herbal products manufacturers in 
California. To obtain insights from consumer advocacy groups, we met 
with officials from the Center for Science in the Public Interest, 
Consumers Union, and Public Citizen. To obtain insights from public 
health organizations, the health care community, and academia, we met 
with officials from the American Association of Poison Control Centers; 
American Medical Association; California Poison Control System; New 
York City Poison Control Center; U.S. Pharmacopoeia; Baylor College of 
Medicine; Critical Path Institute; Center for Advanced Food Technology, 
Rutgers University; Stony Brook University; Center for Consumer Self 
Care, Department of Clinical Pharmacy, and Osher Center for Integrative 
Medicine, University of California, San Francisco; and the University 
of California, Berkeley. 

We conducted this performance audit from December 2007 through January 
2009, in accordance with generally accepted government auditing 
standards. Those standards require that we plan and perform the audit 
to obtain sufficient, appropriate evidence to provide a reasonable 
basis for our findings and conclusions based on our audit objectives. 
We believe that the evidence obtained provides a reasonable basis for 
our findings and conclusions based on our audit objectives. 

[End of section] 

Appendix II: Data on FDA's Actions to Identify and Respond to Safety 
Concerns Related to Dietary Supplements: 

This appendix provides additional detail on FDA's actions to identify 
and respond to safety concerns related to dietary supplements. 

Data on FDA's Actions to Identify Safety Concerns Related to Dietary 
Supplements: 

FDA actions to identify safety concerns related to dietary supplements 
include receiving and analyzing adverse event reports and consumer 
complaints and conducting inspections. 

Data on Adverse Events Related to Dietary Supplements: 

Table 6 compares the number of adverse event reports received and 
entered into FDA's databases for review related to dietary supplements 
and drugs and biologics from January 1, 2003, through December 31, 
2007. 

Table 6: Comparison of the Number of Adverse Event Reports Received and 
Entered into FDA's Databases for Review Related to Dietary Supplements 
and Drugs and Biologics, January 1, 2003, through December 31, 2007: 

Total dietary supplement reports received and entered for review: 
[Empty]. 

Description: Total dietary supplement reports received and entered for 
review; 
Year: 2003: 739; 
Year: 2004: 657; 
Year: 2005: 491; 
Year: 2006: 317; 
Year: 2007: 350; 
Total: 2,554; 
Average: 511. 

Description: Total drugs and biologics reports received and entered for 
review; 
Year: 2003: 226,217; 
Year: 2004: 273,601; 
Year: 2005: 323,384; 
Year: 2006: 337,155; 
Year: 2007: 364,449; 
Total: 1,524,806; 
Average: 304,961. 

Source: GAO analysis of FDA data. 

Notes: Dietary Supplement Reports includes both voluntary and mandatory 
adverse event reports. If a report is incomplete, it is not entered 
into the report database. FDA receives roughly 30 incomplete reports 
related to dietary supplements per month. According to FDA, reporting 
rates were higher in 2003 and 2004 due to adverse events related to 
ephedra. FDA requires firms to report serious and nonserious adverse 
events for new drugs. 

[End of table] 

Table 7 compares the number of dietary supplement-related adverse event 
cases characterized as serious from January 1, 2003, through October 
31, 2008, and the total number of dietary supplement-related adverse 
event cases. 

Table 7: Number of Dietary Supplement-Related Adverse Event Cases 
Characterized as Serious, January 1, 2003, through October 31, 2008: 

Description: Cases characterized as serious; 
Year: 2003: 510[A]; 
Year: 2004: 483; 
Year: 2005: 364; 
Year: 2006: 213; 
Year: 2007: 213; 
Year: 2008: 759; 
Total: 2,542. 

Description: Total number of dietary supplement-related cases; 
Year: 2003: 739; 
Year: 2004: 657; 
Year: 2005: 491; 
Year: 2006: 317; 
Year: 2007: 350; 
Year: 2008: 948; 
Total: 3,502. 

Source: FDA. 

[A] Thirty-six reports did not contain information about seriousness in 
2003. 

[End of table] 

Table 8 shows the number and types of outcomes for all dietary 
supplement-related adverse event cases received by FDA from January 1, 
2003, through October 31, 2008. 

Table 8: Number of Dietary Supplement-Related Adverse Event Complaint 
(AEC) Outcomes for all Adverse Event Cases, January 1, 2003, through 
October 31, 2008: 

Description: Hospitalization; 
Year: 2003: 245; 
Year: 2004: 217; 
Year: 2005: 165;
Year: 2006: 86; 
Year: 2007: 93; 
Year: 2008: 301; 
Total: 1,107; 
Percentage of dietary supplement-related cases: 31.6%. 

Description: Nonserious injuries/illness; 
Year: 2003: 310; 
Year: 2004: 259; 
Year: 2005: 149; 
Year: 2006: 72; 
Year: 2007: 77; 
Year: 2008: 109; 
Total: 976; 
Percentage of dietary supplement-related cases: 27.9%. 

Description: Serious injuries/illness; 
Year: 2003: 35; 
Year: 2004: 100; 
Year: 2005: 113; 
Year: 2006: 38; 
Year: 2007: 43; 
Year: 2008: 540; 
Total: 869; 
Percentage of dietary supplement-related cases: 24.8%. 

Description: Visited a health care provider; 
Year: 2003: 200; 
Year: 2004: 171; 
Year: 2005: 100; 
Year: 2006: 81; 
Year: 2007: 97; 
Year: 2008: 218; 
Total: 867; 
Percentage of dietary supplement-related cases: 24.8%. 

Description: Other serious (important medical events); 
Year: 2003: 0; 
Year: 2004: 0; 
Year: 2005: 13; 
Year: 2006: 92; 
Year: 2007: 99; 
Year: 2008: 407; 
Total: 611; 
Percentage of dietary supplement-related cases: 17.4%. 

Description: Visited an emergency room; 
Year: 2003: 114; 
Year: 2004: 98; 
Year: 2005: 78; 
Year: 2006: 44; 
Year: 2007: 52; 
Year: 2008: 152; 
Total: 538; 
Percentage of dietary supplement-related cases: 15.4%. 

Description: Life-threatening; 
Year: 2003: 89; 
Year: 2004: 108; 
Year: 2005: 51; 
Year: 2006: 41; 
Year: 2007: 64; 
Year: 2008: 118; 
Total: 471; 
Percentage of dietary supplement-related cases: 13.4%. 

Description: Requires intervention to prevent permanent impairment; 
Year: 2003: 82; 
Year: 2004: 127; 
Year: 2005: 68; 
Year: 2006: 24; 
Year: 2007: 28; 
Year: 2008: 40; 
Total: 369; 
Percentage of dietary supplement-related cases: 10.5%. 

Description: Death; 
Year: 2003: 52; 
Year: 2004: 35; 
Year: 2005: 26; 
Year: 2006: 11; 
Year: 2007: 7; 
Year: 2008: 11; 
Total: 142; 
Percentage of dietary supplement-related cases: 4.1%. 

Description: Disability; 
Year: 2003: 33; 
Year: 2004: 37; 
Year: 2005: 14; 
Year: 2006: 17; 
Year: 2007: 14; 
Year: 2008: 19; 
Total: 134; 
Percentage of dietary supplement-related cases: 3.8%. 

Description: Other; 
Year: 2003: 13; 
Year: 2004: 3; 
Year: 2005: 3; 
Year: 2006: 0; 
Year: 2007: 0; 
Year: 2008: 0; 
Total: 19; 
Percentage of dietary supplement-related cases: 0.5%. 

Description: Congenital anomaly; 
Year: 2003: 2; 
Year: 2004: 3; 
Year: 2005: 1; 
Year: 2006: 0; 
Year: 2007: 2; 
Year: 2008: 0; 
Total: 8; 
Percentage of dietary supplement-related cases: 0.2%. 

Description: Total number of cases with AEC outcome[A]; 
Year: 2003: 739; 
Year: 2004: 657; 
Year: 2005: 491; 
Year: 2006: 317; 
Year: 2007: 350; 
Year: 2008: 948; 
Total: 3,502. 

Source: FDA. 

[A] Cases may have more than one adverse event reported outcome; 
therefore, the sum of outcomes exceeds the total number of cases per 
year. 

[End of table] 

Table 9 shows the number of dietary supplement-related adverse event 
cases by product type from January 1, 2003, through October 31, 2008. 

Table 9: Number of All Dietary Supplement-Related Cases with Reported 
Adverse Event Outcomes by Product Classification, January 1, 2003, 
through October 31, 2008: 

Product classification: Combination products and products not elsewhere 
classified; 
Cases: 1,566; 
Percentage of dietary supplement-related cases: 44.7%. 

Product classification: Herbal and botanical (other than teas); 
Cases: 1,017; 
Percentage of dietary supplement-related cases: 29.0%. 

Product classification: Vitamin; 
Cases: 658; 
Percentage of dietary supplement-related cases: 18.8%. 

Product classification: Mineral; 
Cases: 373; 
Percentage of dietary supplement-related cases: 10.7. 

Product classification: Fats and lipid substances; 
Cases: 108; 
Percentage of dietary supplement-related cases: 3.1%. 

Product classification: Herbal and botanical teas; 
Cases: 92; 
Percentage of dietary supplement-related cases: 2.6%. 

Product classification: Protein; 
Cases: 78; 
Percentage of dietary supplement-related cases: 2.2%. 

Product classification: Fiber; 
Cases: 53; 
Percentage of dietary supplement-related cases: 1.5%. 

Product classification: Unknown; 
Cases: 14; 
Percentage of dietary supplement-related cases: 0.4%. 

Product classification: Animal by-products and extracts; 
Cases: 11; 
Percentage of dietary supplement-related cases: 0.3%. 

Product classification: Total number of cases[A]; 
Cases: 3,502. 

Source: FDA. 

[A] Cases may have more than one product classification; therefore, the 
sum of cases by product classification may exceed the total number of 
cases. 

[End of table] 

Data on Consumer Complaints Related to Dietary Supplements: 

Table 10 shows the number of dietary supplement-related consumer 
complaints by adverse event result for fiscal year 2001 through July 3, 
2008. 

Table 10: Number of Dietary Supplement-Related Consumer Complaints by 
Adverse Event Result, Fiscal Year 2001 through July 3, 2008: 

No adverse events or symptoms reported[A]: [Empty]. 

Description: No adverse events or symptoms reported[A]; 
Year: 2001: 111; 
Year: 2002: 98; 
Year: 2003: 81; 
Year: 2004: 69; 
Year: 2005: 64; 
Year: 2006: 60; 
Year: 2007: 50; 
Year: 2008: 53; 
Total: 586; 
Percentage of total dietary supplement-related consumer complaints: 
57.6%. 

Description: Nonlife-threatening illness; 
Year: 2001: 39; 
Year: 2002: 23; 
Year: 2003: 31; 
Year: 2004: 14; 
Year: 2005: 9; 
Year: 2006: 12; 
Year: 2007: 21; 
Year: 2008: 20; 
Total: 169; 
Percentage of total dietary supplement-related consumer complaints: 
16.6%. 

Description: Nonlife-threatening--no adverse event reporting (adverse 
symptoms present)[B]; 
Year: 2001: 10; 
Year: 2002: 20; 
Year: 2003: 25; 
Year: 2004: 20; 
Year: 2005: 17; 
Year: 2006: 22; 
Year: 2007: 27; 
Year: 2008: 23; 
Total: 164; 
Percentage of total dietary supplement-related consumer complaints: 
16.1%. 

Description: Life-threatening illness; 
Year: 2001: 19; 
Year: 2002: 8; 
Year: 2003: 27; 
Year: 2004: 10; 
Year: 2005: 3; 
Year: 2006: 2; 
Year: 2007: 10; 
Year: 2008: 6; 
Total: 85; 
Percentage of total dietary supplement-related consumer complaints: 
8.3%. 

Description: Death; 
Year: 2001: 1; 
Year: 2002: 2; 
Year: 2003: 4; 
Year: 2004: 2; 
Year: 2005: 2; 
Year: 2006: 2; 
Year: 2007: 1; 
Year: 2008: 0; 
Total: 14; 
Percentage of total dietary supplement-related consumer complaints: 
1.4%. 

Description: Total; 
Total: 1018; 
Percentage of total dietary supplement-related consumer complaints: 
100.0%. 

Source: GAO analysis of FDA data. 

Note: FDA pulled these data from its FACTS database. These data are a 
subset of the data provided in table 9. At the time the complaint is 
entered into FACTS, there is no verification that a death, illness, or 
injury was a direct consequence of the dietary supplement consumed. 

[A] This category includes complaints where the adverse event result 
was "None," blank, or "Nonlife-threatening--no adverse event reporting" 
when there were no adverse symptoms present. 

[B] According to an FDA official, "Nonlife-threatening--no adverse 
event reporting" does not mean that an adverse event is not present; 
rather, this category is selected by field staff when they do not have 
enough information initially to fill all of the required fields in the 
adverse event reporting screen within FDA's database for consumer 
complaints. 

[End of table] 

Table 11 shows the number of dietary supplement-related consumer 
complaints with adverse symptoms present by adverse event result and 
FDA product class from fiscal year 2001 through July 3, 2008. 

Table 11: Number of Dietary Supplement-Related Consumer Complaints with 
Adverse Symptoms Present by Adverse Event Result and Product 
Classification, Fiscal Year 2001 through July 3, 2008: 

Description: Death; 
FDA product classification: Herbal and botanical (other than teas): 8; 
FDA product classification: Animal by-products and extracts: 1; 
FDA product classification: Herbal and botanical teas: 1; 
FDA product classification: Combination products and products not 
elsewhere classified: 3; 
FDA product classification: Vitamin: 1; 
FDA product classification: Mineral: 0; 
FDA product classification: Protein: 0; 
FDA product classification: Fats and lipid substances: 0; 
FDA product classification: Other (all other classes): 0; 
Total: 14. 

Description: Life-threatening illness; 
FDA product classification: Herbal and botanical (other than teas): 40; 
FDA product classification: Animal by-products and extracts: 0; 
FDA product classification: Herbal and botanical teas: 3; 
FDA product classification: Combination products and products not 
elsewhere classified: 26; 
FDA product classification: Vitamin: 5; 
FDA product classification: Mineral: 4; 
FDA product classification: Protein: 2; 
FDA product classification: Fats and lipid substances: 1; 
FDA product classification: Other (all other classes): 4; 
Total: 85. 

Description: Nonlife-threatening illness; 
FDA product classification: Herbal and botanical (other than teas): 48; 
FDA product classification: Animal by-products and extracts: 1; 
FDA product classification: Herbal and botanical teas: 5; 
FDA product classification: Combination products and products not 
elsewhere classified: 72; 
FDA product classification: Vitamin: 14; 
FDA product classification: Mineral: 8; 
FDA product classification: Protein: 11; 
FDA product classification: Fats and lipid substances: 3; 
FDA product classification: Other (all other classes): 7; 
Total: 169. 

Description: Nonlife-threatening--no adverse event reporting (adverse 
symptoms present)[A]; 
FDA product classification: Herbal and botanical (other than teas): 43; 
FDA product classification: Animal by-products and extracts: 1; 
FDA product classification: Herbal and botanical teas: 7; 
FDA product classification: Combination products and products not 
elsewhere classified: 54; 
FDA product classification: Vitamin: 21; 
FDA product classification: Mineral: 14; 
FDA product classification: Protein: 11; 
FDA product classification: Fats and lipid substances: 6; 
FDA product classification: Other (all other classes): 7; 
Total: 164. 

Description: Total in product class for complaints with adverse events 
or systems reported; 
FDA product classification: Herbal and botanical (other than teas): 
139; 
FDA product classification: Animal by-products and extracts: 3; 
FDA product classification: Herbal and botanical teas: 16; 
FDA product classification: Combination products and products not 
elsewhere classified: 155; 
FDA product classification: Vitamin: 41; 
FDA product classification: Mineral: 26; 
FDA product classification: Protein: 24; 
FDA product classification: Fats and lipid substances: 10; 
FDA product classification: Other (all other classes): 18; 
Total: 432. 

Description: Percentage of total product classes for complaints with 
adverse events or symptoms reported; 
FDA product classification: Herbal and botanical (other than teas): 
32.2%; 
FDA product classification: Animal by-products and extracts: 0.7%; 
FDA product classification: Herbal and botanical teas: 3.7%; 
FDA product classification: Combination products and products not 
elsewhere classified: 35.9%; 
FDA product classification: Vitamin: 9.5%; 
FDA product classification: Mineral: 6.0%; 
FDA product classification: Protein: 5.6%; 
FDA product classification: Fats and lipid substances: 2.3%; 
FDA product classification: Other (all other classes): 4.2%; 
Total: 100.0%. 

Source: GAO analysis of FDA data. 

Note: FDA pulled these data from its FACTS database. These data are a 
subset of the data provided in table 9. At the time the complaint is 
entered into FACTS, there is no verification that a death, illness, or 
injury was a direct consequence of the dietary supplement consumed. 

[A] According to an FDA official, "Nonlife-threatening--no adverse 
event reporting" does not mean that an adverse event isn't present; 
rather, this category is selected by field staff when they do not have 
enough information initially to fill all of the required fields in the 
adverse event reporting screen within FDA's database for consumer 
complaints. 

[End of table] 

Data on Inspections Related to Dietary Supplements: 

Table 12 shows the number of foreign and domestic inspections of 
dietary supplement facilities compared with food inspections and total 
inspections conducted by FDA and states from fiscal years 2000 through 
2008. 

Table 12: FDA Foreign and Domestic Inspections and State Domestic 
Inspections, Fiscal Years 2000 through 2008: 

Description: FDA foreign: Dietary supplement inspections[A]; 
Fiscal year: 2000: 0; 
Fiscal year: 2001: 0; 
Fiscal year: 2002: 0; 
Fiscal year: 2003: 0; 
Fiscal year: 2004: 0; 
Fiscal year: 2005: 0; 
Fiscal year: 2006: 0; 
Fiscal year: 2007: 0; 
Fiscal year: 2008: 0; 
Total: 0. 

Description: FDA foreign: Foods inspections; 
Fiscal year: 2000: 177; 
Fiscal year: 2001: 211; 
Fiscal year: 2002: 169; 
Fiscal year: 2003: 148; 
Fiscal year: 2004: 153; 
Fiscal year: 2005: 132; 
Fiscal year: 2006: 125; 
Fiscal year: 2007: 96; 
Fiscal year: 2008: 150; 
Total: 1,361. 

Description: FDA foreign: All FDA inspections; 
Fiscal year: 2000: 878; 
Fiscal year: 2001: 892; 
Fiscal year: 2002: 791; 
Fiscal year: 2003: 757; 
Fiscal year: 2004: 932; 
Fiscal year: 2005: 844; 
Fiscal year: 2006: 789; 
Fiscal year: 2007: 1,005; 
Fiscal year: 2008: 933; 
Total: 7,821. 

Description: FDA domestic: Dietary supplement inspections[A]; 
Fiscal year: 2000: 60; 
Fiscal year: 2001: 71; 
Fiscal year: 2002: 66; 
Fiscal year: 2003: 87; 
Fiscal year: 2004: 163; 
Fiscal year: 2005: 167; 
Fiscal year: 2006: 137; 
Fiscal year: 2007: 119; 
Fiscal year: 2008: 65; 
Total: 935. 

Description: FDA domestic: Foods inspections; 
Fiscal year: 2000: 6,728; 
Fiscal year: 2001: 9,811; 
Fiscal year: 2002: 8,742; 
Fiscal year: 2003: 11,295; 
Fiscal year: 2004: 11,013; 
Fiscal year: 2005: 8,775; 
Fiscal year: 2006: 7,510; 
Fiscal year: 2007: 6,500; 
Fiscal year: 2008: 6,559; 
Total: 76,933. 

Description: FDA domestic: All FDA inspections; 
Fiscal year: 2000: 14,257; 
Fiscal year: 2001: 17,785; 
Fiscal year: 2002: 17,854; 
Fiscal year: 2003: 21,812; 
Fiscal year: 2004: 20,898; 
Fiscal year: 2005: 19,013; 
Fiscal year: 2006: 16,869; 
Fiscal year: 2007: 14,623; 
Fiscal year: 2008: 14,328; 
Total: 157,439. 

Description: State domestic: Dietary supplement inspections[A,B]; 
Fiscal year: 2000: 0; 
Fiscal year: 2001: 0; 
Fiscal year: 2002: 4; 
Fiscal year: 2003: 1; 
Fiscal year: 2004: 33; 
Fiscal year: 2005: 39; 
Fiscal year: 2006: 18; 
Fiscal year: 2007: 9; 
Fiscal year: 2008: 1; 
Total: 105. 

Description: State domestic: Foods inspections; 
Fiscal year: 2000: 6,546; 
Fiscal year: 2001: 7,667; 
Fiscal year: 2002: 7,921; 
Fiscal year: 2003: 8,252; 
Fiscal year: 2004: 8,763; 
Fiscal year: 2005: 9,388; 
Fiscal year: 2006: 8,918; 
Fiscal year: 2007: 9,751; 
Fiscal year: 2008: 9,183; 
Total: 76,389. 

Description: State domestic: All state inspections; 
Fiscal year: 2000: 16,312; 
Fiscal year: 2001: 18,078; 
Fiscal year: 2002: 21,160; 
Fiscal year: 2003: 20,625; 
Fiscal year: 2004: 21,894; 
Fiscal year: 2005: 22,381; 
Fiscal year: 2006: 23,935; 
Fiscal year: 2007: 25,146; 
Fiscal year: 2008: 23,373; 
Total: 192,904. 

Source: FDA. 

Note: Food inspections, all FDA inspections, and all state inspections 
categories include dietary supplement inspections that were conducted 
during the designated time period. 

[A] Dietary supplement inspections excludes those inspections related 
to dietary supplements with drug or veterinary uses. Data is current as 
of November 19, 2008. Because FDA's inspection database is continuously 
updated, these numbers may change as state and district offices enter 
new information or existing information is corrected. 

[B] According to an FDA official, dietary supplement inspections 
conducted by states during this time period were performed under a 
partnership agreement rather than a FDA contract. 

[End of table] 

Table 13 shows the percentage of dietary supplement inspections where 
investigators identified problems, from fiscal year 2002 through May 6, 
2008. 

Table 13: Share of Dietary Supplement Inspections Where Investigators 
Identified Problems, Fiscal Year 2002 through May 6, 2008A: 

Description: Inspections where problems were identified[B]; 
Fiscal year: 2002: 40; 
Fiscal year: 2003: 47; 
Fiscal year: 2004: 86; 
Fiscal year: 2005: 116; 
Fiscal year: 2006: 82; 
Fiscal year: 2007: 52; 
Fiscal year: 2008: 25; 
Total: 448. 

Description: Total number of inspections; 
Fiscal year: 2002: 70; 
Fiscal year: 2003: 88; 
Fiscal year: 2004: 196; 
Fiscal year: 2005: 206; 
Fiscal year: 2006: 155; 
Fiscal year: 2007: 128; 
Fiscal year: 2008: 66; 
Total: 909. 

Description: Percentage of inspections where investigators identified 
problems; 
Fiscal year: 2002: 57.1%; 
Fiscal year: 2003: 53.4%; 
Fiscal year: 2004: 43.9%; 
Fiscal year: 2005: 56.3%; 
Fiscal year: 2006: 52.9%; 
Fiscal year: 2007: 40.6%; 
Fiscal year: 2008: 37.9%; 
Total: 49.3%. 

Source: GAO analysis of FDA data. 

[A] Dietary supplement inspections excludes those inspections related 
to dietary supplements with drug or veterinary uses. 

[B] Problems identified includes both potential violations, as well as 
observations of problems by investigators that may fall below FDA's 
threshold for regulatory action. 

[End of table] 

Data on FDA's Actions to Respond to Safety Concerns Related to Dietary 
Supplements: 

FDA actions to respond to safety concerns related to dietary 
supplements include issuing warning letters to dietary supplement 
firms, requesting recalls, and detaining and refusing imports. 

Data on Dietary Supplement-Related Warning Letters: 

Table 14 shows the number of Federal Food, Drug, and Cosmetic Act 
violations cited in 293 dietary supplement-related warning letters 
issued from fiscal years 2002 through 2007. 

Table 14: Number of Violations in the Federal Food, Drug, and Cosmetic 
Act Cited in 293 FDA Dietary Supplement-Related Warning Letters, Fiscal 
Years 2002 through 2007: 

Violation description: Unapproved new drug--product lacks FDA approval 
to manufacture and sell as a drug; 
Federal Food, Drug, and Cosmetic Act section: 505; 
Number of violations in the 293 letters: 219; 
Percentage of total violations: 41.0%. 

Violation description: Misbranded drug--product label is false or 
misleading, lacks adequate directions for use, or otherwise does not 
meet other drug labeling requirements; 
Federal Food, Drug, and Cosmetic Act section: 502; 
Number of violations in the 293 letters: 153; 
Percentage of total violations: 28.7%. 

Violation description: Misbranded food--product label is false or 
misleading, bears unauthorized claims, does not list all ingredients, 
lacks required nutrition information, or does not meet other food 
labeling requirements; 
Federal Food, Drug, and Cosmetic Act section: 403; 
Number of violations in the 293 letters: 136; 
Percentage of total violations: 25.5%. 

Violation description: Adulterated food--product contains ingredients 
that are unsafe, fraudulent, unapproved, or otherwise unfit for food; 
Federal Food, Drug, and Cosmetic Act section: 402; 
Number of violations in the 293 letters: 9; 
Percentage of total violations: 1.7%. 

Violation description: Unapproved food additive--product contains a 
food additive that lacks FDA approval or that is not used in conformity 
with the regulation prescribing conditions for safe use of the 
additive; 
Federal Food, Drug, and Cosmetic Act section: 409; 
Number of violations in the 293 letters: 4; 
Percentage of total violations: 0.7%. 

Violation description: Drug facility registration--firm failed to 
register its manufacturing facility with FDA as a drug facility; 
Federal Food, Drug, and Cosmetic Act section: 510; 
Number of violations in the 293 letters: 4; 
Percentage of total violations: 0.7%. 

Violation description: Import or export violations--product violates 
import or export requirements; 
Federal Food, Drug, and Cosmetic Act section: 801; 
Number of violations in the 293 letters: 3; 
Percentage of total violations: 0.6%. 

Violation description: Food contaminated with pesticides--product 
contains unsafe type or level of pesticides; 
Federal Food, Drug, and Cosmetic Act section: 408; 
Number of violations in the 293 letters: 2; 
Percentage of total violations: 0.4%. 

Violation description: New dietary ingredient--product contains a new 
dietary ingredient that lacks adequate information to provide 
reasonable assurance of safety; 
Federal Food, Drug, and Cosmetic Act section: 413; 
Number of violations in the 293 letters: 2; 
Percentage of total violations: 0.4%. 

Violation description: Food facility registration--firm failed to 
register as a food facility; 
Federal Food, Drug, and Cosmetic Act section: 415; 
Number of violations in the 293 letters: 1; 
Percentage of total violations: 0.2%. 

Violation description: Prescription needed--firm failed to require 
dispensation of product by prescription; 
Federal Food, Drug, and Cosmetic Act section: 503; 
Number of violations in the 293 letters: 1; 
Percentage of total violations: 0.2%. 

Total violations: 
Number of violations in the 293 letters: 534; 
Percentage of total violations: 100.0%. 

Source: GAO analysis of FDA's online database of warning letters. 

Note: Because FDA's online database may not include all the warning 
letters issued by FDA, these numbers represent minimums only. 

[End of table] 

Table 15 shows the number of dietary supplement-related warning letters 
compared with total warning letters issued by FDA from fiscal years 
2002 through 2007. 

Table 15: FDA Dietary Supplement-Related Warning Letters and All Other 
FDA Warning Letters Issued, Fiscal Years 2002 through 2007: 

Dietary supplement letters: [Empty]. 

Description: Dietary supplement letters; 
Fiscal year: 2002: 23; 
Fiscal year: 2003: 67; 
Fiscal year: 2004: 38; 
Fiscal year: 2005: 52; 
Fiscal year: 2006: 70; 
Fiscal year: 2007: 43; 
Total: 293. 

Description: Total warning letters; 
Fiscal year: 2002: 806; 
Fiscal year: 2003: 761; 
Fiscal year: 2004: 730; 
Fiscal year: 2005: 519; 
Fiscal year: 2006: 526; 
Fiscal year: 2007: 434; 
Total: 3,776. 

Description: Percentage of total warning letters;
Fiscal year: 2002: 2.9%; 
Fiscal year: 2003: 8.8%; 
Fiscal year: 2004: 5.2%; 
Fiscal year: 2005: 10.0%; 
Fiscal year: 2006: 13.3%; 
Fiscal year: 2007: 9.9%; 
Total: 7.8%. 

Source: GAO analysis of FDA's online database of warning letters. 

Note: Because FDA's online database may not include all the warning 
letters issued by FDA, these numbers represent minimums only. In 
addition to warning letters, FDA also sent untitled letters to dietary 
supplement companies for violations that did not meet the threshold of 
regulatory significance to trigger a warning letter. According to FDA, 
the agency sent approximately 240 untitled letters from 2003 through 
2007. 

[End of table] 

Data on Recalls Related to Dietary Supplements: 

Table 16 provides information on examples of Class I recalls related to 
dietary supplement products from fiscal years 2003 through 2008. 
According to FDA, Class I recalls are related to products that are 
dangerous and defective and pose a serious health concern. A firm may 
initiate a recall independently of FDA, or FDA may request a firm 
recall a product upon identifying a problem with a product. 

Table 16: Examples of Dietary Supplement-Related Class I Recalls, 
Fiscal Years 2003 through 2008: 

Fiscal year by recall date: 2003; 
Reason for recall: Misbranded--product claims to be dairy-free when it 
contains a milk derivative; 
Product description: Calcium/vitamin D supplement. 

Fiscal year by recall date: 2003; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplements promoted for sexual function. 

Fiscal year by recall date: 2003; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplements promoted for sexual function. 

Fiscal year by recall date: 2003; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2003; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2003; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2004; 
Reason for recall: Misbranded--product contains excessive level of 
vitamin D; 
Product description: Multivitamin. 

Fiscal year by recall date: 2005; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2005; 
Reason for recall: Adulterated--products contain aristolochic acid, a 
potent carcinogen and toxin; 
Product description: Herbal supplements. 

Fiscal year by recall date: 2005; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2005; 
Reason for recall: Misbranded--product contains undeclared milk 
derivative; 
Product description: Children's chewable calcium tablets. 

Fiscal year by recall date: 2005; 
Reason for recall: Unapproved new drug--product prescription drug for 
treating Type 2 diabetes; 
Product description: Herbal supplement. 

Fiscal year by recall date: 2005; 
Reason for recall: Adulterated--product contains ephedrine alkaloids; 
Product description: Supplement promoted for energy increase. 

Fiscal year by recall date: 2006; 
Reason for recall: Adulterated--product contains ephedrine alkaloids; 
Product description: Supplement promoted for weight loss. 

Fiscal year by recall date: 2006; 
Reason for recall: Misbranded--product contains undeclared milk 
derivatives; 
Product description: Calcium supplement. 

Fiscal year by recall date: 2006; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2006; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Misbranded--product may contain undeclared milk 
protein; 
Product description: Protein supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Misbranded--product contains undeclared milk; 
Product description: Protein supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Misbranded--product contains undeclared milk 
derivative; 
Product description: Protein supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Misbranded--product contains undeclared fish 
gelatin; 
Product description: Multivitamin. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analogs of 
various pharmaceuticals for erectile dysfunction; 
Product description: Herbal supplement promoted for energy increase and 
male sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Adulterated--product may contain salmonella; 
Product description: Shark cartilage supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Adulterated--product may contain salmonella; 
Product description: Shark cartilage supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Misbranded--product contains undeclared soy; 
Product description: Calcium supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2007; 
Reason for recall: Adulterated--product may contain salmonella; 
Product description: Shark cartilage supplement. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for weight loss; 
Product description: Supplement promoted for weight loss. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analogs of 
various pharmaceuticals for erectile dysfunction; 
Product description: Supplements promoted for increasing sexual 
function. 

Fiscal year by recall date: 2007; 
Reason for recall: Unapproved new drug--product contains analogs of 
various pharmaceuticals for erectile dysfunction; 
Product description: Supplements promoted for increasing sexual 
function. 

Fiscal year by recall date: 2007; 
Reason for recall: Adulterated--product contains cryptosporidium, a 
parasite that can cause intestinal infection, reported illness 
associated with product; 
Product description: Herbal supplement promoted for treating upset 
stomach in infants. 

Fiscal year by recall date: 2008; 
Reason for recall: Adulterated--product may be contaminated with mold; 
Product description: Folic acid liquid supplement. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Adulterated--product contains elevated levels of 
selenium and chromium, reported illnesses associated with the product; 
Product description: Liquid dietary supplement. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains various 
pharmaceuticals for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains pharmaceutical 
for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Fiscal year by recall date: 2008; 
Reason for recall: Unapproved new drug--product contains analog of 
pharmaceutical for erectile dysfunction; 
Product description: Herbal supplement promoted for sexual function. 

Source: GAO analysis of FDA data available on FDA's Web site. 

Note: These recalls are only examples of Class I recalls during this 
time period. We could not provide complete data on the number of 
recalls because FDA's official recalls database was not sufficiently 
reliable for the purposes of this report. 

[End of table] 

Data on Imports Related to Dietary Supplements: 

Table 17 shows the number of detentions without physical examination of 
imported dietary supplement products by general violation categories 
from fiscal year 2002 through March 24, 2008. 

Table 17: Dietary Supplement-Related Detentions without Physical 
Examination (DWPE) by General Violation Categories, Fiscal Year 2002 
through March 24, 2008A: 

Violation description: Adulterated--product appears to contain an 
unsafe substance, or appears to have been prepared under insanitary 
conditions or in a facility that lacks manufacturing controls or does 
not otherwise meet FDA regulations; 
Dietary supplement entry lines DWPE: 1,623; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 50.3%. 

Violation description: Misbranded--product label appears to be false or 
misleading, or appears to not meet labeling requirements; 
Dietary supplement entry lines DWPE: 1,109; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 34.4%. 

Violation description: Unapproved new drug--product appears to lack FDA 
approval to manufacture and sell as a drug; 
Dietary supplement entry lines DWPE: 324; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 10.0%. 

Violation description: Other; 
Dietary supplement entry lines DWPE: 162; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 5.0%. 

Violation description: Adulterated--firm appears to have unlawfully 
omitted or substituted an ingredient in the product; 
Dietary supplement entry lines DWPE: 7; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 0.2%. 

Violation description: Total; 
Dietary supplement entry lines DWPE: 3,225; 
Percentage of total violations for dietary supplement import entry 
lines DWPE: 100.0%. 

Source: GAO analysis of FDA data. 

[A] When identifiable, this table excludes products for animal uses, 
topical products, cosmetics, and other products that do not meet the 
statutory definition of a dietary supplement. Data includes dietary 
supplement products for drug uses. 

[End of table] 

Table 18 shows the number of detentions without physical examination of 
imported dietary supplement products by product classification from 
fiscal year 2002 through March 24, 2008. 

Table 18: Dietary Supplement-Related DWPE by Product Classification, 
Fiscal Year 2002 through March 24, 2008A: 

Product classification[B]: Herbal and botanical (other than teas); 
Dietary supplement entry lines DWPE: 1,049; 
Percentage of dietary supplement entry lines DWPE: 32.5%. 

Product classification[B]: Herbal and botanical teas; 
Dietary supplement entry lines DWPE: 750; 
Percentage of dietary supplement entry lines DWPE: 23.3%. 

Product classification[B]: Vitamin; 
Dietary supplement entry lines DWPE: 628; 
Percentage of dietary supplement entry lines DWPE: 19.5%. 

Product classification[B]: Protein; 
Dietary supplement entry lines DWPE: 527; 
Percentage of dietary supplement entry lines DWPE: 16.3%. 

Product classification[B]: Animal by-products and extracts; 
Dietary supplement entry lines DWPE: 136; 
Percentage of dietary supplement entry lines DWPE: 4.2%. 

Product classification[B]: Combination products and products not 
elsewhere classified; 
Dietary supplement entry lines DWPE: 54; 
Percentage of dietary supplement entry lines DWPE: 1.7%. 

Product classification[B]: Mineral; 
Dietary supplement entry lines DWPE: 36; 
Percentage of dietary supplement entry lines DWPE: 1.1%. 

Product classification[B]: Other; 
Dietary supplement entry lines DWPE: 25; 
Percentage of dietary supplement entry lines DWPE: 0.8%. 

Product classification[B]: Fats and lipid substances; 
Dietary supplement entry lines DWPE: 20; 
Percentage of dietary supplement entry lines DWPE: 0.6%. 

Product classification[B]: Total; 
Dietary supplement entry lines DWPE: 3,225; 
Percentage of dietary supplement entry lines DWPE: 100.0%. 

Source: GAO analysis of FDA data. 

[A] When identifiable, this table excludes products for animal uses, 
topical products, cosmetics, and other products that do not meet the 
statutory definition of a dietary supplement. Data includes dietary 
supplement products for drug uses. 

[B] Product classifications for import entry lines are submitted by 
customs brokers and are not determined by FDA unless reviewed and 
corrected during an examination. Accordingly, some entry lines may be 
incorrectly classified. 

[End of table] 

Table 19 shows the number of Federal Food, Drug, and Cosmetic Act 
violations cited in 3,605 dietary supplement-related import refusals 
from fiscal year 2002 through March 24, 2008. 

Table 19: Number of Violations of the Federal Food, Drug, and Cosmetic 
Act Cited in 3,605 Dietary Supplement-Related Import Refusals, Fiscal 
Year 2002 through March 24, 2008A: 

Violation description: Misbranded--product label appears to be false or 
misleading, or appears to not meet labeling requirements; 
Number of violations for the 3,605 lines refused: 3,193; 
Percentage of total violations: 57.4%. 

Violation description: Adulterated--product appears to contain an 
unsafe substance, or appears to have been prepared under insanitary 
conditions or in a facility that lacks manufacturing controls or does 
not otherwise meet FDA regulations; 
Number of violations for the 3,605 lines refused: 1,366; 
Percentage of total violations: 24.6%. 

Violation description: Unapproved new drug--product appears to lack FDA 
approval to manufacture and sell as a drug; 
Number of violations for the 3,605 lines refused: 730; 
Percentage of total violations: 13.1%. 

Violation description: Other; 
Number of violations for the 3,605 lines refused: 258; 
Percentage of total violations: 4.6%. 

Violation description: Adulterated--firm appears to have unlawfully 
omitted or substituted an ingredient in the product; 
Number of violations for the 3,605 lines refused: 13; 
Percentage of total violations: 0.2%. 

Violation description: Total; 
Number of violations for the 3,605 lines refused: 5,560; 
Percentage of total violations: 100.0%. 

Source: GAO analysis of FDA data. 

[A] When identifiable, this table excludes products for animal uses, 
topical products, cosmetics, and other products that do not meet the 
statutory definition of a dietary supplement. Data includes dietary 
supplement products for drug uses. 

[End of table] 

Table 20 shows the number of refused imports of dietary supplement 
products by product classification from fiscal year 2002 through March 
24, 2008. 

Table 20: Dietary Supplement-Related Import Refusals by Product 
Classification, Fiscal Year 2002 through March 24, 2008A: 

Product classification[B]: Herbal and botanical (other than teas); 
Dietary supplement entry lines refused: 1,378; 
Percentage of dietary supplement entry lines refused: 38.2%. 

Product classification[B]: Combination products, and products not 
elsewhere classified; 
Dietary supplement entry lines refused: 900; 
Percentage of dietary supplement entry lines refused: 25.0%. 

Product classification[B]: Herbal and botanical teas; 
Dietary supplement entry lines refused: 569; 
Percentage of dietary supplement entry lines refused: 15.8%. 

Product classification[B]: Vitamin; 
Dietary supplement entry lines refused: 408; 
Percentage of dietary supplement entry lines refused: 11.3%. 

Product classification[B]: Animal by-products and extracts; 
Dietary supplement entry lines refused: 111; 
Percentage of dietary supplement entry lines refused: 3.1%. 

Product classification[B]: Protein; 
Dietary supplement entry lines refused: 71; 
Percentage of dietary supplement entry lines refused: 2.0%. 

Product classification[B]: Mineral; 
Dietary supplement entry lines refused: 65; 
Percentage of dietary supplement entry lines refused: 1.8%. 

Product classification[B]: Other; 
Dietary supplement entry lines refused: 59; 
Percentage of dietary supplement entry lines refused: 1.6%. 

Product classification[B]: Fats and lipid substances; 
Dietary supplement entry lines refused: 43; 
Percentage of dietary supplement entry lines refused: 1.2%. 

Product classification[B]: Total; 
Dietary supplement entry lines refused: 3,604; 
Percentage of dietary supplement entry lines refused: 100.0%. 

Source: GAO analysis of FDA data. 

[A] When identifiable, this table excludes products for animal uses, 
topical products, cosmetics, and other products that do not meet the 
statutory definition of a dietary supplement. Data includes dietary 
supplement products for drug uses. 

[B] Product classifications for import entry lines are submitted by 
customs brokers and are not determined by FDA unless reviewed and 
corrected during an examination. Accordingly, some entry lines may be 
incorrectly classified. 

[End of table] 

Data on FDA Enforcement Actions Related to Dietary Supplements: 

FDA's enforcement actions related to dietary supplements include 
seizures, injunctions, and criminal investigations. Table 21 shows 
information about dietary supplement-related seizure and injunction 
actions taken from fiscal year 2002 through July 18, 2008. 

Table 21: FDA Seizures and Injunctions Related to Dietary Supplement 
Products, Fiscal Year 2002 through July 18, 2008A: 

Fiscal year: 2002; 
Type of action: Seizure; 
Date filed: 10/22/2001; 
Individual/company: Biogenics Inc.; E'OLA International; and Nature's 
Energy, Inc.; 
Product description: Various weight-loss products; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2002; 
Type of action: Seizure; 
Date filed: 2/5/2002; 
Individual/company: Spectramin, Inc.; 
Product description: Various products for joint health, vitality, 
energy, and weight loss, among others; 
Reason: Unapproved new drug/misbranded drug;
Note: [Empty]. 

Fiscal year: 2002; 
Type of action: Seizure; 
Date filed: 6/10/2002; 
Individual/company: Dandy Day Corporation; 
Product description: Product promoted for weight loss; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2002; 
Type of action: Seizure; 
Date filed: 9/25/2002; 
Individual/company: Zibo Fuxing PharmacyCo, Ltd./Sino King 
International Development and Management Group, Inc.; 
Product description: Herbal product to treat or prevent mental 
development disorders and diseases; 
Reason: Misbranded food, unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 10/15/2002; 
Individual/company: Humphrey Laboratories, Inc., Kirkman Laboratories; 
Product description: Product to treat or prevent autism; 
Reason: Misbranded food, unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 12/13/2002; 
Individual/company: Halo Supply, Co.; 
Product description: Product to treat or prevent cold, flu, and other 
viral conditions; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 2/4/2003; 
Individual/company: Global Source Management and Consulting Inc.; 
Product description: Various products promoted to treat or prevent 
medical conditions, including enlarged prostate, joint health, and 
cholesterol reduction; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 6/16/2003; 
Individual/company: Seasilver USA, Inc.(Southern District of 
California); 
Product description: Product promoted to treat or prevent hypoglycemia, 
diabetes, cancer, psoriasis, hepatitis, and arthritis; 
Reason: Misbranded food, unapproved new drug/misbranded drug; 
Note: Related consent decree of condemnation and permanent injunction 
filed 3/9/04. Product was also seized from Ohio on 6/24/03. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 6/19/2003; Individual/company: Shop America; 
Product description: Product promoted to treat or prevent cancer, heart 
disease, and various degenerative diseases; 
Reason: Misbranded food, unapproved new drug/misbranded drug; 
Note: Related consent decree of condemnation and permanent injunction 
filed 12/17/03. 

Fiscal year: 2003; 
Type of action: Injunction; 
Date filed: 9/16/2003; Individual/company: Hi-Tech Pharmaceuticals, 
National Urological Group, National Institute for Clinical Weight Loss, 
American Weight Loss Clinic, United Metabolic Research Center, and 
Jared R. Wheat; 
Product description: Various products promoted to treat or prevent 
obesity and erectile dysfunction; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2003; 
Type of action: Seizure; 
Date filed: 9/18/2003; 
Individual/company: Jean's Greens; 
Product description: Herbal product promoted to treat or prevent 
serious diseases, such as cancer; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2004; 
Type of action: Seizure; 
Date filed: 1/22/2004; 
Individual/company: EAS/Musclemaster.com, Inc., NVE Pharmaceuticals, 
Inc.; 
Product description: Various products promoted to build muscle mass; 
Reason: Misbranded food; 
Note: [Empty]. 

Fiscal year: 2005; 
Type of action: Seizure; 
Date filed: 11/22/2004; 
Individual/company: Asia MedLabs, Inc.; 
Product description: Herbal product to treat or prevent flu, poisoning, 
allergies, blood pressure, and other heart ailments; 
Reason: Adulterated food, unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2005; 
Type of action: Seizure; 
Date filed: 12/15/2004; 
Individual/company: FCC Products, Inc.; 
Product description: Ginseng contaminated with pesticides; 
Reason: Adulterated food; 
Note: [Empty]. 

Fiscal year: 2005; 
Type of action: Seizure; 
Date filed: 2/11/2005; 
Individual/company: ATF Fitness Products, Inc.; 
Product description: Weight-loss products containing ephedra; 
Reason: Adulterated food and misbranded food; 
Note: [Empty]. 

Fiscal year: 2006; 
Type of action: Injunction; 
Date filed: 10/14/2005; 
Individual/company: Vita-ERB, Ltd. Mary and Moses Barnes and Fred 
Paulicka; 
Product description: Herbal product marketed with disease claims; 
Reason: Unapproved new drug/misbranded drug, adulterated drug; 
Note: [Empty]. 

Fiscal year: 2006; 
Type of action: Seizure; 
Date filed: 11/28/2005; 
Individual/company: Nature's Treat, Inc.; 
Product description: Product containing ephedra promoted for increasing 
energy; 
Reason: Adulterated food; 
Note: Products also seized at distributor on the same date. 

Fiscal year: 2006; 
Type of action: Seizure; 
Date filed: 1/9/2006; Individual/company: ATF Fitness Products, Inc.; 
Product description: Product containing ephedra; 
Reason: Adulterated food; 
Note: [Empty]. 

Fiscal year: 2006; 
Type of action: Injunction; 
Date filed: 2/3/2006; 
Individual/company: Natural Ovens Bakery, Paul and Barbara Stitt, 
Matthew Taylor; 
Product description: Various supplement mixes; 
Reason: Misbranded food, unapproved new drug/misbranded drug; 
Note: Injunction included food products as well. 

Fiscal year: 2006; 
Type of action: Seizure; 
Date filed: 2/22/2006; 
Individual/company: Hi-Tech Pharmaceuticals, Inc.; 
Product description: Products containing ephedra; 
Reason: Adulterated food; 
Note: [Empty]. 

Fiscal year: 2006; 
Type of action: Seizure; 
Date filed: 9/5/2006; 
Individual/company: Advantage Nutraceuticals, LLC; 
Product description: Various products including those promoted to treat 
or prevent cancer and arthritis; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2007; 
Type of action: Seizure; 
Date filed: 12/29/2006; 
Individual/company: Vitality Products Co., Inc.; 
Product description: Various products promoted to treat or prevent 
serious diseases, such as cancer, heart disease, Alzheimer's disease, 
and others; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2007; 
Type of action: Seizure; 
Date filed: 8/22/2007; 
Individual/company: Charron Nutrition; 
Product description: Various products promoted to treat or prevent 
diabetes, arthritis, and other serious medical conditions; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Seizure; 
Date filed: 10/18/2007; 
Individual/company: FulLife Natural Options, Inc.; 
Product description: Various products promoted to treat or prevent 
diabetes, anemia, and hypertension, among other conditions; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Seizure; 
Date filed: 10/29/2007; 
Individual/company: General Therapeutics, Corporation; 
Product description: Products manufactured under insanitary conditions; 
Reason: Unapproved new drug, adulterated drug, adulterated food; 
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Injunction; 
Date filed: 2/12/2008; 
Individual/company: Brownwood Acres Foods Inc., Cherry Capital 
Services, Inc., Stephen de Tar, Robert Underwood; 
Product description: Various products promoted to treat or prevent 
cancer, arthritis, gout, heart disease, and Alzheimer's disease, among 
others; 
Reason: Unapproved new drug/misbranded drug, misbranded food; 
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Seizure; 
Date filed: 3/25/2008; 
Individual/company: Shangai Distributor, Inc.; 
Product description: Various products promoted for sexual enhancement 
and to treat erectile dysfunction; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Seizure; 
Date filed: 4/2/2008; 
Individual/company: LG Sciences, LLC; 
Product description: Products promoted for bodybuilding and containing 
unapproved dietary ingredients and unapproved food additives; 
Reason: Adulterated food;
Note: [Empty]. 

Fiscal year: 2008; 
Type of action: Seizure; 
Date filed: 7/18/2008; 
Individual/company: Sei Pharmaceuticals, Inc.; 
Product description: Various products promoted for sexual enhancement 
and to treat erectile dysfunction; 
Reason: Unapproved new drug/misbranded drug; 
Note: [Empty]. 

Source: GAO analysis of FDA data. 

[A] In some cases, FDA may have initiated multiple actions for a 
particular product such as seizing the same product from different 
companies or locations (e.g., distributor). These related actions are 
listed in the notes column. 

[End of table] 

Table 22 summarizes dietary supplement-related criminal investigations 
resulting in at least one conviction or with charges filed from 2002 
through July 31, 2008. 

Table 22: Number of Criminal Investigations Related to Dietary 
Supplements Resulting in a Conviction or Charges Filed from 2002 
through July 31, 2008: 

Description: Cases resulting in at least one conviction (state or 
federal); 
Number of cases: 14. 

Description: Cases with charges filed (state or federal); 
Number of cases: 5. 

Description: Total; 
Number of cases: 19. 

Source: GAO analysis of FDA data. 

Note: Cases with charges filed includes cases where specific charges 
have been filed within the judicial system and indictments. This 
category excludes cases where charges may have been filed but the case 
was not pursued further (e.g., prosecution declined or case dismissed). 

[End of table] 

[End of section] 

Appendix III: Comparison of Select Foreign Countries' Regulation of 
Dietary Supplements with the United States: 

In comparison with the United States, Canada and Japan have more 
regulatory requirements in place for dietary supplements and related 
products. On the other hand, the United States has developed specific 
good manufacturing practices for dietary supplements while the United 
Kingdom has not. Table 23 compares the regulatory framework for dietary 
supplement products in these foreign countries with the U.S. regulatory 
system. 

Table 23: Comparison of Dietary Supplement Regulations: United States, 
Canada, United Kingdom, and Japan: 

Country: United States; 
Product registration: [Empty]; 
Manufacturer registration: [Check] (limited); 
Premarket approval of products: [Empty]; 
Specific good manufacturing practices: [Check]; 
Serious mandatory adverse event reporting by industry: [Check]. 

Country: Canada; 
Product registration: [Check]; 
Manufacturer registration: [Check][A]; 
Premarket approval of products: [Check]; 
Specific good manufacturing practices: [Check]; 
Serious mandatory adverse event reporting by industry: [Check]. 

Country: United Kingdom; 
Product registration: [Empty]; 
Manufacturer registration: [Check] 
Premarket approval of products: [Check][B] (limited); 
Specific good manufacturing practices: [Empty]; 
Serious mandatory adverse event reporting by industry: [Check][C]. 

Country: Japan[D]; 
Product registration: [Check]; 
Manufacturer registration: [Check]; 
Premarket approval of products: [Check]; 
Specific good manufacturing practices: [Check][E]; 
Serious mandatory adverse event reporting by industry: [Empty]. 

Source: GAO. 

Note: GAO did not independently verify descriptions of foreign laws. 

[A] Manufacturers, packagers, labelers, and importers of natural health 
products must obtain a site license to perform these activities. 

[B] Under European Community (E.C.) law, novel supplements without a 
history of consumption in the European Union prior to May 1997, or 
foods containing genetically-modified ingredients are subject to 
premarket approval for safety. 

[C] According to a U.K. official, under E.C. law, firms must report any 
problems with products to the local and national authorities. 

[D] Foods for Specified Health Uses (FOSHU) products only. 

[E] According to a Japanese official, Japan does not have separate good 
manufacturing practice regulations for dietary supplement products; 
however, firms applying to use a FOSHU claim on a product must provide 
evidence that quality control procedures are in place for that 
particular product. 

[End of table] 

In Canada, companies are required to obtain a product license to market 
natural health products, which include a range of products, such as 
vitamin and mineral supplements, herbal remedies, and other products, 
based upon their medicinal ingredients and intended uses. The product 
licensing application must include detailed information about the 
product, ingredients, potency, intended use, and evidence supporting 
the product's safety and efficacy. Approved products are assigned a 
license number that is displayed on the product label. Manufacturers, 
packagers, labelers, and importers of natural health products must 
obtain a site license to perform these activities. To obtain a site 
license, a firm must provide evidence of quality control procedures 
that meet government standards for good manufacturing practices. Firms 
are required to report any serious adverse reactions associated with 
their products within 15 days and must provide information summarizing 
all adverse reactions, including mild or moderate events, on an annual 
basis. 

In the United Kingdom (U.K.), dietary supplements are legally termed 
"food supplements" and are regulated under food law--most of which is 
European Community (E.C.) legislation implemented at the national 
level, according to a U.K. official. Food supplements are generally not 
subject to premarket approval. For example, any supplement that either 
meets the guidelines established under E.U. law for specific vitamins 
and minerals, or does not include a new or genetically modified 
ingredient, does not require approval prior to marketing. According to 
a U.K. official, most direct oversight of the dietary supplement 
industry in the United Kingdom occurs at the local level of government. 
For example, all investigations, enforcement actions, and monitoring 
activities such as inspections are undertaken at the local level. Food 
supplement firms are required to register with local authorities and 
should detail the specific activities undertaken at each establishment 
as part of this process. However, centralized information on registered 
firms is not collected or maintained at a national level. Additionally, 
there is no centralized registry of food supplement products in the 
U.K. Although government standards for food good manufacturing 
practices apply to food supplement manufacturing, there are no good 
manufacturing practice guidelines specific for food supplements. Under 
E.C. law, firms are required to report any problems with food products 
to the local and national authorities and, if the product is injurious 
to health, the firm must remove it from the market. 

In Japan, products are regulated based on their product claims. There 
are two types of claims: Food with Nutrient Function Claims (FNFC), 
which are standardized, preapproved claim statements for certain 
vitamins and minerals with established benefits, and Food for Specified 
Health Uses (FOSHU) claims, which require government approval for 
safety and efficacy prior to marketing a product advertised as having a 
physiological effect on the body. Since FNFC claims are standardized 
and preapproved, firms do not need to notify the government prior to 
marketing a product using an approved FNFC claim, provided the product 
meets established ingredient content specifications. To use a FOSHU 
claim on a product, a firm is required to provide the government with 
evidence supporting the product's physiological effect and safety prior 
to marketing. Additionally, a firm must provide information on the firm 
and its product to the government, as well as evidence of quality 
control processes. 

[End of section] 

Appendix IV: Comments from the Department of Health and Human Services: 

Department of Health and Human Services: 
Office of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

January 22, 2009: 

Lisa Shames: 
Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 

Dear Ms. Shames: 

Enclosed are comments on the U.S. Government Accountability Office's 
(GAO) report entitled: "Dietary Supplements: FDA Should Take Further 
Actions to Improve Oversight and Consumer Understanding," (GAO-09-250). 

The Department appreciates the opportunity to review this report before 
its publication. 

Sincerely, 

Signed by: 

Barbara Pisaro Clark: 
Acting Assistant Secretary for Legislation: 

Attachment: 

[End of letter] 

Department of Health and Human Services: 
Food and Drug Administration: 
Silver Spring, MD 20993: 

January 22, 2009: 

To: Assistant Secretary for Legislation: 

From: FDA Chief of Staff: 

Subject: FDA's General Comments to the U.S. Government Accountability
Office's (GAO) Draft Report Entitled: Dietary Supplements: FDA
Should Take Further Actions to Improve Oversight and Consumer
Understanding (GAO-09-250). 

FDA is providing the attached general comments to the U.S. Government 
Accountability Office's draft report entitled, Dietary Supplements: FDA 
Should Take Further Actions to Improve Oversight and Consumer 
Understanding (GAO-09-250). 

We appreciate the opportunity to review and comment on this draft 
correspondence before it is published. 

Signed by: 

Susan C. Winckler, R. Ph., Esq. 

FDA's General Comments to the U.S. Government Accountability Office's 
(GAO) Draft Report Entitled: Dietary Supplements: FDA Should Take 
Further Actions to Improve Oversight and Consumer Understanding (GAO-09-
250): 

The Food and Drug Administration (FDA or the Agency) welcomes the GAO 
report as a means of calling attention to the challenges that the 
Agency faces with respect to regulating dietary supplements and 
conventional foods formulated with added dietary ingredients.[Footnote 
10] 

As part of its responsibility to protect the general public health from 
unnecessary risks associated with FDA-regulated products, FDA has taken 
action to alert the public to potential problems associated with 
products marketed as dietary supplements. Last year, for example 

* FDA warned consumers not to purchase or consume Total Body Formula, a 
liquid multivitamin-multimineral supplement, because it contained 
unsafe levels of selenium and chromium that could lead to illness. 

* FDA warned against the use of the products Blue Steel and Hero, 
marketed as dietary supplements, because they contained undeclared drug 
ingredients that could present a serious risk of harm to consumers 
using the products. 

* FDA initiated seizure actions against several dietary supplement 
products because of the presence of undeclared drug ingredients or 
because they contained steroid ingredients that were not legal to 
market in dietary supplements. 

* FDA issued 23 warning letters in December 2008 to marketers of 
purported dietary supplements because they contained an undeclared drug 
ingredient used to treat diabetes. 

* FDA continued to identify and take enforcement action against dietary 
supplements making illegal disease treatment claims. For example, 
between June and September 2008 FDA issued 28 warning letters to firms 
that were marketing fake cancer cures, many of which were marketed as 
dietary supplements. 

* FDA continues to make progress toward accomplishing other related 
tasks, even though funding is limited. As noted in the current draft 
report, FDA issued draft guidance to implement the labeling, reporting, 
and recordkeeping provisions of the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act, and FDA took steps to 
update internal systems and processes for collecting and analyzing 
serious adverse event reports submitted to FDA. 

GAO Recommendation 1: 

To improve the information available to FDA for identifying safety 
concerns and better enable FDA to meet its responsibility to protect 
the public health, we recommend that the Secretary of the Department of 
Health and Human Services direct the Commissioner of FDA to request 
authority to require dietary supplement companies to: 

* Identify themselves as a dietary supplement company as part of the 
existing registration requirements and update this information 
annually, 

* Provide a list of all dietary supplement products they sell and a 
copy of the labels and update this information annually, and, 

* Report all adverse events related to dietary supplements. 

FDA Response to Recommendation 1: 

In general, FDA agrees that the Agency's ability to ensure the safety 
of dietary supplements used by consumers could be improved if FDA had 
more information on the identity of firms marketing dietary supplements 
as well as the identity and composition of the products they market. 
However, it is not clear that all the information would actually 
enhance product safety. For example, the GAO draft report recommends 
that FDA require firms to report all adverse events related to dietary 
supplements. Although receiving all adverse events on dietary 
supplements could theoretically enhance our ability to detect signals 
of potential toxicity over time, we are uncertain whether, in practice, 
such information would advance the Agency's ability to identify unsafe 
dietary supplements or to do so quickly. For example, an unintended 
outcome of receiving such reports might be that the huge increase in 
minor adverse event reports might make it more difficult to filter out 
signals of potential toxicity generated by reports of serious adverse 
events and thus delay the identification of safety problems with 
dietary supplements. However, FDA is working on methodologies to try to 
mitigate this concern and improve data mining for safety-related 
signals if the Agency were to receive all adverse event reports. 

GAO Recommendation 2: 

To better enable FDA to meet its responsibility to regulate dietary 
supplements that contain new dietary ingredients, we recommend that the 
Secretary of the Department of Health and Human Services direct the 
Commissioner of FDA to issue guidance to clarify when an ingredient is 
considered a new dietary ingredient, the evidence needed to document 
the safety of new dietary ingredients, and appropriate methods for 
establishing ingredient identity. 

FDA Response to Recommendation 2: 

FDA agrees that guidance would be helpful to clarify when an ingredient 
is considered a new dietary ingredient (NDI), the evidence needed to 
document the safety of NDIs, and appropriate methods for establishing 
the identity of a NDI. The Agency held a public meeting in November 
2004 to seek public comment on several issues related to the NDI 
requirements of section 413(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350b(a)(2)). FDA specifically asked for 
information that would enable the Agency to identify ways to assist 
submitters of NDI notifications to ensure that they contain the 
information the Agency needs to evaluate the notification and to 
clarify statutory requirements in the Dietary Supplement Health and 
Education Act of 1994 (DSHEA) that pertain to NDIs. The Agency has 
reviewed the information submitted by interested parties on this 
subject and has developed draft guidance addressing the NDI 
notification requirements of the Federal Food, Drug, and Cosmetic Act. 
The guidance is currently undergoing internal FDA review. 

GAO Recommendation 3: 

To help ensure that companies follow the appropriate laws and 
regulations and renew a recommendation we made in July 2000, we 
recommend that the Secretary of the Department of Health and Human 
Services direct the Commissioner of FDA to provide guidance to industry 
to clarify when products should be marketed as either dietary 
supplements or foods with added dietary ingredients. 

FDA Response to Recommendation 3: 

As we noted in our comment to the GAO July 2000 report, FDA's Dietary 
Supplement Strategic Plan recognized the need to clarify the boundaries 
between dietary supplements and conventional foods, including 
conventional foods with added dietary ingredients. As we noted when the 
Plan was released in January 2000, FDA acknowledged its inability to 
set timeframes for all the activities listed in the Plan because of 
resource limitations. FDA will consider this recommendation and the 
priority and timing to implement this recommendation in light of the 
Agency's limited resources and competing priorities. 

GAO Recommendation 4: 

To improve consumer understanding about dietary supplements and better 
leverage existing resources, we recommend that the Secretary of the 
Department of Health and Human Services direct the Commissioner of FDA 
to coordinate with stakeholder groups involved in consumer outreach to 
(1) identify additional mechanisms-such as the recent WebMD partnership-
for educating consumers about the safety, efficacy, and labeling of 
dietary supplements, (2) implement these mechanisms, and (3) assess 
their effectiveness. 

FDA Response to Recommendation 4: 

In principle, FDA agrees that more information about the use of dietary 
supplements would help consumers who are trying to determine whether 
the use of a particular supplement is safe or desirable in light of 
their personal health. However, the Agency is unsure that FDA is best 
situated to meet this consumer need. Although FDA does, as the report 
notes, engage in some consumer education and outreach, our resources 
available for this type of activity are extremely limited. Moreover, 
DSHEA recognized that the National Institutes of Health (NIH) is well 
situated to undertake the resource-intensive task of conducting and 
compiling scientific research on dietary supplements, dietary 
ingredients, and their effects on the body. In fact, the NIH's Office 
of Dietary Supplements offers a number of consumer-oriented Fact 
Sheets, databases of dietary supplement research activities, and 
literature citations, for the purpose of educating the public to foster 
an enhanced quality of life and health for the U.S. population. Thus, 
FDA believes that it may be useful to explore a possible collaboration 
between FDA and NIH as an efficient and cost-effective way to expand 
and further our current outreach activities on dietary supplements. FDA 
also believes that collaboration with other stakeholders may be useful 
for communicating information on the safety and uses of dietary 
supplements to the general public. In this regard, FDA is identifying 
areas of consumer information appropriate for the recently announced 
FDA/WebMD partnership, referenced in the GAO report. We anticipate that 
information on dietary supplements will be included. 

r/d: ONLDS, BMoore, BFrankos: 1/5/09: 
Clearance ONLDS, MPoos: 1/5/09: 
Edits: NYanish: 1/6/09: 
Edits: HSeltzer: 1/6/09: 
Edits: DCooper: 1/6/09: 
Edits: TMattia: 1/6/09: 
Edits: ACrawford: 1/6/09: 
Edits & Review: ONLDS, BMoore, BFrankos, MPoos: 1/7/09: 
Edits & EOS Clearance: BHarden, 1/7/09: 
Edit: MPoos/BFrankos, 1/8/09: 
Edits/Clearance: MLanda, 1/9/09: 
Edits/CGrillo 1/14/09: 
Edited LNickerson 1/15/09: 
Reviewed CGrillo 1/16/09: 
Edits and OFP Clearance CNelson 1/21/09: 
Edited D.Foellmer 1/21/09: 
Edited P. Quest at NIH 1/22/09: 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841, shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, José Alfredo Gómez, 
Assistant Director; Kevin Bray; Nancy Crothers; Michele Fejfar; Alison 
Gerry Grantham; Barbara Patterson; Minette Richardson; Lisa Van 
Arsdale; and Chloe Wardropper made key contributions to this report. 

[End of section] 

Footnotes: 

[1] GAO, Food Safety: Improvements Needed in Overseeing the Safety of 
Dietary Supplements and "Functional Foods," [hyperlink, 
http://www.gao.gov/products/GAO/RCED-00-156] (Washington, D.C.: July 
11, 2000). 

[2] Department of Health and Human Services Office of Inspector 
General, Dietary Supplement Labels: An Assessment (Washington, D.C.: 
March 2003). 

[3] FDA's estimate was published in the Federal Register on September 
15, 2008, in accordance with the Paperwork Reduction Act of 1995. The 
estimate is based on a 2000 FDA-commissioned study that examined 
factors affecting adverse event reporting for drugs and vaccines and 
then qualitatively assessed the potential impact of those factors for 
voluntary dietary supplement adverse event reporting. 

[4] For more information on food inspections performed under state 
contract agreements, see GAO, Food Labeling: FDA Needs to Better 
Leverage Resources, Improve Oversight, and Effectively Use Available 
Data to Help Consumers Select Healthy Foods, GAO-08-597 (Washington, 
D.C.: Sept. 9, 2008). 

[5] Department of Health and Human Services, U.S. Food and Drug 
Administration, Food Protection Plan: An Integrated Strategy for 
Protecting the Nation's Food Supply (Washington, D.C.: November 2007). 

[6] Reports of mild or moderate reactions to dietary supplements may be 
considered a serious adverse event report if, based on reasonable 
medical judgment, a medical intervention was necessary to prevent a 
serious outcome. 

[7] For more information on FDA resources by Center, see GAO, Food 
Safety: Improvements Needed in FDA Oversight of Fresh Produce, 
[hyperlink, http://www.gao.gov/products/GAO-08-1047] (Washington, D.C.: 
Sept. 26, 2008). 

[8] For more information on foreign inspections conducted by FDA, see 
GAO, Federal Oversight of Food Safety: FDA Has Provided Few Details on 
the Resources and Strategies Needed to Implement its Food Protection 
Plan, [hyperlink, http://www.gao.gov/products/GAO-08-909T] (Washington, 
D.C.: June 12, 2008). 

[9] Department of Health and Human Services' Office of Inspector 
General, Dietary Supplement Labels: An Assessment (Washington, D.C.: 
March 2003). 

[10] The term "dietary ingredient" is not generally used to refer to 
ingredients added to conventional foods, as it refers to a category of 
ingredients that, by definition, are for use in dietary supplements. 
The Federal Food, Drug, and Cosmetic Act defines "dietary supplement" 
as a product intended to supplement the diet that (among other 
requirements) bears or contains one or more dietary ingredients (21 
U.S.C. 321(ff)( I )). The dietary supplement definition defines 
"dietary ingredient" to mean vitamins, minerals, herbs and other 
botanicals, amino acids, and "dietary substances," as well as 
concentrates, metabolites, constituents, extracts, and combinations of 
such ingredients (21 U.S.C. 321(ft)(1)). 

Although the statute uses "dietary ingredient" only for ingredients 
that are used or intended for use in dietary supplements, GAO uses the 
term more broadly to include the same category of ingredients when 
added to a conventional food. Consistent with GAO's broader use of 
"dietary ingredient," these comments also use "dietary ingredient" to 
include all the types of ingredients listed in 21 U.S.C. 321(ff)(I), 
whether they are intended for use in dietary supplements or in 
conventional foods. 

When added to conventional foods, dietary ingredients are not regulated 
under the legal requirements for dietary ingredients used in a dietary 
supplement. Rather, a dietary ingredient added to a conventional food 
is regulated under the same legal requirements as any other ingredient 
added to a conventional food (i.e., as a food additive requiring FDA 
approval unless the ingredient is generally recognized as safe (GRAS) 
for its intended use in food or otherwise excepted from the food 
additive definition in 21 U.S.C. 321(s)). 

[End of section] 

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