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GAO Says FDA Should Better Regulate Dietary Supplements

Mar 3, 2009 | Parker Waichman Alonso LLP

The U.S. Food and Drug Administration (FDA) was the subject of a report released today by the Government Accountability Office (GAO) urging the agency to implement improvements on its monitoring and governing of dietary supplements, the LA Times reported.

"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.  According to the LA Times, the report also indicated that, in the United States, vitamins, minerals, and herbs accounted for a $24.7 billion business in 2007.

The FDA has been the focus of much criticism in recent years with concerns over product liability and the agency’s ability to monitor and ensure safety, said the LA Times.  And, while some progress has been made, the GAO cited an extensive list of flaws that included, said the LA Times, that some herbal product manufacturers are not required to self-identify as dietary supplement companies and some companies are under no obligation to supply the FDA with details on products sold; manufacturers are not required to report mild or moderate reactions, only serious, adverse events; and the FDA not only maintains few oversight resources, but is unable to appropriately remove a product from the market.

The GAO also recommended, said the LA Times, that the U.S. Department of Health and Human Services (HHS) instruct the FDA commissioner to obtain added regulatory authority over supplement manufacturers and that such manufacturers produce a list of products and labels and report all adverse events. The FDA is also being urged to clarify when an ingredient is considered "new," as well as to clarify what is needed to document new ingredient safety.

Meanwhile, the enormous peanut butter salmonella scandal that has sickened over 600 and is linked to nine deaths, prompted President Barack Obama to order a “complete review” of the FDA, making the announcement in an interview on the Today Show with Matt Lauer last month.

The agency has long been criticized for a wide variety of issues, conflicts, and failures, with the recent, highly publicized peanut butter debacle causing outrage nationwide.  Said Obama, the peanut butter contamination that has hit nearly every state and Canada was just the most recent in an array of “instances over the last several years” in which “the FDA has not been able to catch some of these things as quickly as I expect them to catch,” reported Today in an earlier report.

Today noted that critics routinely pointed to the recent Bush administration as having “crippled” the FDA with eight years of budget cuts and a refusal to conduct an overhaul of the failing agency.  “At bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter,” said Obama in the Today Show interview, adding that, “we are going to make sure that we retool the FDA, that it’s operating in a highly professional fashion and, most importantly, that we prevent these things, as opposed to trying to catch them after they’ve already occurred.”