February 11, 2010
The heat is on. The Government Accountability Office has contacted several dietary supplement marketers asking for evidence that products don’t contain new dietary ingredients and for safety documentation. Under the Dietary Supplement Health and Education Act of 1994, supplement manufacturers are responsible for ensuring supplement safety and for registering only new (meaning pre-DSHEA) dietary ingredients with the FDA before sale.
In addition, the GAO has issued a not-so-concisely-titled report “Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.” The report asks the FDA to act on supplement safety concerns, noting that the FDA has seen a threefold increase in adverse event reports related to dietary supplements in the past year.
Several natural products industry players have bones of contention with the GAO’s actions:
The American Herbal Products Association says that the products that have been the subject of the GAO letters “are primarily long-established ingredients, such as chamomile flower tincture, echinacea root 4:1 powdered extract, and oils of peppermint leaf, ginger root, and fennel seed.” In other words, they're not new.
Also, the legislation requiring AERs of dietary supplements did not go into effect until 2008, so you’d expect to see an increase since that time. But even with the increase in AERs for supplements, pharmaceuticals have more—far more. According to the Council for Responsible Nutrition, during the first full year that the law requiring manufacturers to report serious adverse events was in effect, the FDA reported receiving 1,080 adverse event reports for all dietary supplement products. For the same year, the FDA received more than 526,000 adverse event reports related to prescription drugs, including close to 50,000 deaths.
Dietary supplements are on the government’s radar this year perhaps due to the increased pressure on lawmakers to address food safety, perhaps due to a brighter spotlight on sports supplements during the Olympics and perhaps due to the government’s lack of understanding of existing legislation related to supplements.
Do we need additional laws and/or more FDA oversight of supplements?
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