FDA should step up monitoring of dietary supplements, GAO says

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The Government Accountability Office today released a report urging improvements in how the Food and Drug Administration monitors and governs dietary supplements.

‘Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers,’ the report states.

Vitamins, minerals and herbs constituted a $24.7 billion business in the United States in 2007, the report notes. However, concerns have been raised about product reliability and the FDA’s ability to monitor product safety. In recent years, the FDA has made some progress to protect the public from unsafe products. For example, the FDA mandates the reporting of serious adverse events related to supplements. But the GAO report found a long list of flaws in the FDA’s approach. For example, the GAO said:

• Some companies that make herbal products are not required to identify themselves as dietary supplement companies.
• Some companies are not required to provide the FDA with information on the products they sell.
• Manufacturers are required to report only serious adverse events, not mild or moderate problems.
• The FDA has few resources for oversight.
• The FDA has insufficient ability to remove a product from the market.

The report recommends that the U.S. Department of Health and Human Services direct the FDA commissioner to seek additional regulatory authority over supplement manufacturers. Manufacturers should be required to produce a list of their products, their labels and report all adverse events. The FDA should also clarify when an ingredient is consider ‘new’ and what evidence is needed to document the safety of new ingredients.

-- Shari Roan