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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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.

GAO noted that: (1) the Food and Drug Administration's (FDA) efforts and federal laws provide limited assurances of the safety of functional foods and dietary supplements; (2) while the extent to which unsafe products reach consumers is unknown, GAO believes weaknesses in three areas of the regulatory system increase the likelihood of such occurrences; (3) potentially unsafe products may reach consumers for a variety of reasons, including the lack of a clearly defined safety standard for new dietary ingredients in dietary supplements; (4) some products do not have safety-related information on their labels, which could endanger some consumers; (4) this occurs because FDA has not issued regulations or guidance on the information required; (5) FDA cannot effectively assess whether a functional food or dietary supplement is adversely affecting consumers' health because, among other things, it does not investigate most reports it receives of health problems potentially caused by these products; (6) FDA officials recognize these weaknesses but say a lack of resources has precluded them from taking actions to correct them; (6) GAO also found that agencies' efforts and federal laws concerning health-related claims on product labels and in advertising provide limited assistance to consumers in making informed choices and do little to protect them against inaccurate and misleading claims; (7) FDA has not clearly established the nature and extent of evidence companies need to adequately support structure/function claims and has taken no actions against companies making claims that the agency believes to be questionable; (8) according to a FDA official, the agency has chosen to use its limited resources on regulating product safety rather than on taking enforcement actions against problematic label claims; (9) furthermore, federal agencies operate under different statutes for regulating claims on product labels and in advertising, which has led to claims being made in products' advertisements that were not allowed on product labels; (10) for example, a product that FDA does not allow to claim to lower cholesterol on its label is permitted by the Federal Trade Commission to make this claim in its advertising, provided the claim is truthful, not misleading, and supported by reliable scientific evidence; (11) consumers may not understand the different purposes of health claims and structure/function claims; and (12) as a result, they may incorrectly view structure/function claims as claims to reduce the risk of or treat a disease.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Matters for Congressional Consideration

    Matter: 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.

    Status: Closed - Not Implemented

    Comments: Congress has not shown any indication that it plans to address this recommendation.

    Matter: 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.

    Status: Closed - Not Implemented

    Comments: Congress has not shown any indication that it plans to address this recommendation.

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: 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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