Dietary Supplements:

FDA Should Take Further Actions to Improve Oversight and Consumer Understanding

GAO-09-250: Published: Jan 29, 2009. Publicly Released: Mar 2, 2009.

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 Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary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

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 For example, FDA has modified its data system, issued draft guidance, and conducted outreach to industry.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.

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

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: FDA has issued draft guidance, but we are waiting for the guidance to beome final to close the recommendation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: 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. We are waiting for the draft guidance to become final to close the recommendation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: 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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