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Highlights

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 Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 1. To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to improve the information available to FDA for identifying safety concerns and better enable FDA to meet its responsibility to protect the public health, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to request authority to require dietary supplement companies to (1) identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually, (2) provide a list of all dietary supplement products they sell and a copy of the labels and update this information annually, and (3) report all adverse events related to dietary supplements.
Closed - Implemented
FDA officials told us they requested additional authority as part of the FDA Food Safety and Modernization Act of 2011 (FSMA) to modify the list of required food categories that FDA uses to identify firms by industry as part of existing registration requirements. In August 2012, FDA published draft guidance expanding the list of food categories required at registration to include dietary supplement categories that were previously optional. FDA issued final guidance in October 2012. Requiring dietary supplement firms to provide information on the products they sell has been part of multiple proposed legislative efforts but has not become law. Mandatory reporting of all adverse events for dietary supplement firms was proposed in S. 3002, the Dietary Supplement Safety Act of 2010, sponsored by Senators McCain and Dorgan, but did not pass the Senate. Although these efforts did not become law, the recommendation was closed because FDA did what GAO asked by requesting the necessary authorities.
Department of Health and Human Services 2. To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should 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.
Closed - Not Implemented
In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. To close the recommendation as implemented, FDA would need to finalize its draft new dietary ingredient guidance. As of December 2017, FDA has yet to issue final guidance, so we are closing the recommendation as not implemented.
Department of Health and Human Services 3. To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to help ensure that companies follow the appropriate laws and regulations and to renew a recommendation we made in July 2000, the Secretary of the Department of Health and Human Services should 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.
Closed - Implemented
FDA issued two final guidance documents in January 2014 that responded to this recommendation. Specifically, FDA issued "Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages" and "Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements." Both of these guidance documents clarify the boundary between conventional foods, such as beverages, and dietary supplements. The second guidance document also clarifies how products should be marketed when substances, such as dietary ingredients, are added.
Department of Health and Human Services 4. To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and 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 should 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.
Closed - Implemented
FDA has completed two of the three components of this recommendation: identifying mechanisms for educating consumers and implementing the mechanisms. Although it did not complete the third component--assessing the mechanisms--we closed the recommendation because FDA had done the majority of what was asked. Agency officials said that assessing the effectiveness of these mechanisms would take a sizable effort that they would have to consider in light of their other priorities.

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