Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products
Highlights
What GAO Found
From 2008 through 2011, the Department of Health and Human Services' Food and Drug Administration (FDA) received 6,307 reports of health problems--adverse event reports (AER)--for dietary supplements; 71 percent came from industry as serious adverse events as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA's product categories. However, FDA may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events. From 2008 to 2010, these centers received over 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said that they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.
To help ensure firms are complying with AER requirements (i.e., submitting serious AERs, maintaining AER records, and including firms' contact information on product labels), FDA increased its inspections of supplement firms and took some actions against noncompliant firms. Specifically, FDA increased firm inspections from 120 in 2008 to 410 from January 1 to September 30, 2012. Over this period, FDA took the following actions: 3 warning letters, 1 injunction, and 15 import refusals related to AER violations, such as not including contact information on the product label or submitting a serious AER.
FDA has used AERs for some consumer protection actions (e.g., inspections and warning letters) but may be able to expand their use. FDA officials said that most AERs do not initiate or support such actions because it is difficult to establish causality between the product and the health problem based on the limited information in an AER. However, FDA does not systematically collect information on how it uses AERs for consumer protection actions; by collecting this information, it may be able to assess whether AERs are being used to their fullest extent. In addition, FDA is not required to provide information to the public about potential safety concerns from supplement AERs as it does for drugs. Making such information public, if consistent with disclosure provisions in existing law, could expand FDA's use of AERs and improve consumer awareness and understanding of potential health events associated with dietary supplements.
FDA has partially implemented all of GAO's 2009 recommendations, such as issuing guidance for new dietary ingredients, clarifying the boundary between dietary supplements and conventional foods, and expanding partnerships to improve consumer understanding. Specifically, FDA developed draft guidance in 2009, 2011, and 2012 to address three GAO recommendations about dietary supplement oversight and formed new partnerships to conduct consumer outreach. However, FDA has not issued final guidance in two cases. FDA officials said that they plan to complete implementation, but they have provided no time frame to do so. With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA's enforcement burden in these areas.
Why GAO Did This Study
Dietary supplements, such as vitamins and botanical products, are a multibillion dollar industry; national data show that over half of all U.S. adults consume them. FDA regulates dietary supplements and generally relies on postmarket surveillance, such as monitoring AERs, to identify potential concerns. Since December 2007, firms receiving a serious AER have had to report on it to FDA within 15 days. In January 2009, GAO reported that FDA had taken several steps to implement AER requirements and had recommended actions to help FDA identify and act on safety concerns for dietary supplements. GAO was asked to examine FDA's use of AERs in overseeing dietary supplements. This report examines the (1) number of AERs FDA has received since 2008, their source, and types of products identified; (2) actions FDA has taken to ensure that firms are complying with AER requirements; (3) extent to which FDA is using AERs to initiate and support its consumer protection efforts; and (4) extent to which FDA has implemented GAO's 2009 recommendations. GAO analyzed FDA data, reviewed FDA guidance, and interviewed FDA officials.
Recommendations
GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to continue efforts to explore all possible options to obtain poison center data if the agency determines that the data could inform FDA's ability to identify potential safety concerns from adverse event reports for dietary supplements. |
In our 2013 report, "Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products," we concluded that consumers and others may not be voluntarily reporting information to FDA on all dietary supplement adverse events that occur, although they may be contacting poison centers about some of these events. Because FDA officials said that their greatest challenge to identifying potential safety concerns from adverse event reports (AERs) is the relatively small number of AERs the agency receives, we also concluded that,depending on the results of its review of the data,FDA could benefit from obtaining access to poison center data for analysis. We therefore recommended that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to continue its efforts to explore all possible options to obtain poison center data if the agency determines that the data could inform FDA's ability to identify potential safety concerns from AERs for dietary supplements. In response to our recommendation, in September 2016 FDA secured a contract for access to the full poison center database including poison center data on dietary supplements after determining that the data would help FDA identify potential safety signals. As a result, the agency has begun to use the data obtained under this contract, in conjunction with AERs, to improve signal detection and monitoring for dietary supplements including through information gathering and trend analysis according to FDA officials.
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| Department of Health and Human Services | To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions). |
In July 2018, FDA officials stated that the agency had modernized its AER database to track when AERs are evaluated by FDA reviewers. The agency was in the process of implementing the ability to track when individual AERs are used to support consumer protection actions by linking AER data to compliance actions, and expected this work to be completed by January 2019. Implementation of the modernized portal for the public and industry reporting of adverse events was also estimated to occur in January 2019. However, in August 2019, FDA reported that, owing to unanticipated IT issues, delays in clearance of the modernized portal, and the January 2019 government shutdown, FDA had to push back the January 2019 target date for the implementation of the modernized AE portal and mechanism for tracking compliance actions associated with AERs. As of August 2019, FDA anticipated that this new portal would be released to the public in early FY 2020 to aid in the collection of more structured public health data. According to FDA, the new portal will be the first phase for improving FDA's ability to quickly assess and determine risk of reported problems and illnesses. They further indicated that, to best determine how to systematically collect data linking compliance actions to AERs, FDA is analyzing IT and business processes as part of a multi-year initiative to improve tracking and coordination related to the AERs received about dietary supplements. This includes the development of requirements for system and business workflow mechanisms that will track and document public health actions taken in response to AERs that are processed. In August 2020, FDA reported that given staff's current deployment efforts to support the response to COVID-19, the timeline for completion of the updated reporting mechanism is now September 2021. Because the recommendation had been open for several years with no significant action, we have closed it as not implemented.
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| Department of Health and Human Services | To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to implement the agency's efforts to facilitate industry reporting of mandatory AERs electronically. |
On January 13, 2014 FDA sent a letter to dietary supplement manufacturers, packers and distributors announcing that they will begin accepting online submissions of voluntary and mandatory dietary supplement adverse event reports through the Safety Reporting Portal (SRP).
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| Department of Health and Human Services | To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to determine what additional information FDA can provide to the public about dietary supplement AERs consistent with existing law and make the information publicly available and readily accessible on its website. |
In our 2013 report, "Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products," we concluded that to the extent that FDA could do so under existing law, providing greater information about dietary supplement AERs to the public, such as identified potential safety concerns and redacted data on its website, could create opportunities for external researchers to use AERs and to improve consumer awareness and understanding of potential health problems associated with dietary supplements. We therefore recommended that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to determine what additional information FDA can provide to the public about dietary supplement AERs consistent with existing law and make the information publicly available and readily accessible on its website. In response to our recommendation, FDA began posting raw data extracted from the Center for Food Safety and Applied Nutrition's AERS database for cosmetics and conventional food, including dietary supplements, on December 6, 2016. The data include demographic, product, symptom, and patient outcome information. Consequently, FDA's information about AERs associated with dietary supplements is more transparent and may be more useful to researchers, health care professionals, and consumers.
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| Department of Health and Human Services | To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to establish a time frame for issuing final guidance for the draft (1) New Dietary Ingredient (NDI) guidance and (2) guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. |
Although FDA issued final guidance for distinguishing liquid dietary supplements from beverages in January 2014, as of September 5, 2017, FDA still had not issued final guidance on new dietary ingredients. Because the guidance had not been issued and FDA has not indicated if or when it will issue such guidance, we are closing this recommendation as not implemented.
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