Inside Washington

April 26, 2009



The Government Accountability Office (GAO; Washington, DC) released a scathing report in March urging vast improvements in how FDA (Rockville, MD) 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 stated.

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

For example, the report noted:

  • Some companies that make herbal products are not required to identify themselves as dietary supplement companies.

  • Some companies are not required to provide FDA with information on the products they sell.

  • Manufacturers are required to report only serious adverse events, not mild or moderate problems.

  • FDA has few resources for oversight.

  • FDA has insufficient ability to remove a product from the market.

 

"This report highlights significant gaps in FDA's ability to ensure the safety of dietary supplements," commented Representative Henry Waxman (D–CA), chairman of the House Energy and Commerce Committee. "Because of limitations on FDA's authority and its lack of resources, consumers don't have the assurance they should that all supplements are safe."

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

In response to the GAO report, Steve Mister, president of the Council for Responsible Nutrition (CRN; Washington, DC), shifted attention to FDA's congested work load as a barrier to properly regulating the supplement industry, rather than the agency's lack of resources. "FDA is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork not resulting in true benefits," Mister said.

Mister added that FDA should concentrate its limited resources on tighter enforcement with a view of ensuring that all companies live up to their commitments to protecting consumers and producing beneficial supplement products.

David Seckman, executive director of the Natural Products Association (NPA; Washington, DC), agreed with Mister. "If FDA's resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense," Seckman said.

He further stated, "There is little scientific data regarding underreporting of adverse events, and the data [the report] cites are not specific to dietary supplements. Rather, they represent all FDA-regulated products, including pharmaceuticals, a category that accounts for more than 460,000 reports annually."