Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and 'Functional Foods'
RCED-00-156
Published: Jul 11, 2000. Publicly Released: Jul 11, 2000.
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Highlights
GAO examined the extent to which agencies' efforts and federal laws ensure the: (1) safety of functional foods and dietary supplements; and (2) accuracy of health-related claims on product labels and in advertising.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| To help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, Congress may wish to amend the Federal Food, Drug, and Cosmetic Act to require makers of functional foods to meet the same requirements that apply to dietary supplements: (1) advance notification to FDA regarding ingredients that companies have determined are safe; (2) notification to FDA regarding the use of structure/function claims; and (3) disclaimers of FDA approval on product labels containing structure/function claims. | Congress has not shown any indication that it plans to address this recommendation. | |
| To help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, Congress may wish to establish an expert panel to reexamine the approach to labelling, which distinguishes health claims from structure/function claims, to determine whether the intended distinctions can be made clear and meaningful to consumers, or failing this, to identify other changes needed to improve consumers' understanding of health-related claims. | Congress has not shown any indication that it plans to address this recommendation. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm timeframes in its plan and take other necessary steps to clarify the boundary between conventional foods, including functional foods, and dietary supplements, particularly the circumstances under which dietary supplements may be marketed in food form. |
According to FDA, in light of limited resources and competing agency priorities and activities, FDA has not issued any regulations or guidance documents that address this recommendation. Given that it is now June 2006, it has already been six years since we made the recommendation, and FDA has indicated no plans to address this recommendation in the future, this recommendation will be closed as not implemented.
|
| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm timeframes in its plan and take other necessary steps to develop and promulgate regulations or other guidance for industry on the safety-related information required on labels for dietary supplements and functional foods. |
According to FDA, in light of limited resources and competing agency priorities and activities, FDA has not issued any regulations or guidance documents that address this recommendation. Given that it is now June 2006, it has already been six years since we made the recommendation, and FDA has not indicated any plans to address this recommendation in the future, this recommendation will be closed as not implemented.
|
| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm timeframes in its plan and take other necessary steps to develop an enhanced system to record and analyze reports of health problems associated with functional foods and dietary supplements. |
With targeted funding provided by Congress, FDA's Center for Food Safety and Applied Nutrition (CFSAN) developed a new adverse event reporting system called CAERS which allows the agency to more effectively record, track, and analyze all reports of consumer complaints and adverse events related to CFSAN-regulated products, including functional foods and dietary supplements.
|
| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm time frames in its plan and take other necessary steps to develop and promulgate regulations or other guidance for industry on the evidence needed to support structure/function claims. |
According to FDA, in November 2004, the agency announced in the Federal Register the availability of draft guidance on substantiation of structure function claims for dietary supplements. The notice provided for comments until January 10, 2005. FDA is now in the process of reviewing the comments and considering what action to take. Given that it is now June 2006, it has already been six years since we made the recommendation, FDA has no firm timetable for finishing its work, and it remains unknown whether FDA's final action, if any, will address the intent of our recommendation, this recommendation will be closed as not implemented.
|
| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm timeframes in its plan and take other necessary steps to develop and implement a strategy for identifying and taking appropriate enforcement actions against companies marketing products with unsupported structure/function claims on their labels. |
FDA has developed an enforcement plan for dietary supplements and, during the summer of 2002, FDA for the first time took court action to seize dietary supplements based on unsubstantiated claims about their effect on the structure or function of the body. According to FDA, these cases will provide a model for future enforcement actions.
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| Food and Drug Administration | While FDA has recognized in its 10-year plan to implement the Dietary Supplement Health and Education Act the need for many of the actions GAO is recommending, the agency has not stated when or how it will address these issues. Therefore, to help ensure that functional foods and dietary supplements are safe and that consumers receive accurate information about them, the Commissioner of FDA should establish firm timeframes in its plan and take other necessary steps to develop and promulgate regulations or other guidance for industry on the evidence needed to document the safety of new dietary ingredients in dietary supplements. |
According to FDA, the agency has re-structured the 75-day new dietary ingredient notification review process and has held a public meeting to solicit comments on FDA's pre-market notification for new dietary ingredients. The agency has reviewed the comments and is considering whether to propose streamlining the safety review process for new dietary ingredients. Neither of these actions directly addresses the intent of our recommendation. Given that it is now June 2006, it has already been six years since we made the recommendation, FDA has no firm timetable for finishing its work, and it remains unknown whether FDA's final action, if any, will address the intent of our recommendation, this recommendation will be closed as not implemented.
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