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Hydroxycut Recall Prompts Call for DSHEA Reform

May 8, 2009 | Parker Waichman LLP The recent Hydroxycut recall has prompted one advocacy group to call on Congress to reform a law that governs the regulation of dietary supplements.  The group, Reality Coalition, argues that  the Dietary Supplement Health and Education Act, or DSHEA, does little to protect consumers from unsafe supplements like Hydroxycut until it's too late.

Last week, the Food & Drug Administration (FDA) ordered the Hydroxycut recall after it had received 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 19-year-old died as a result of Hydroxycut-associated liver damage. That death occurred in 2007, but was only reported to the agency in March.

The agency had also received reports linking Hydroxycut products to seizures, cardiac problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Under DSHEA, supplement makers don't need to seek premarket approval of  products unless they contain a "new dietary ingredient."   Only then must they complete a premarket review of safety data, which typically involves clinical trials.  As a result, the side effects of a supplement product usually are not apparent until it has been on the market for a while, and if users report adverse event to the FDA.

Under DSHEA, the FDA  also lacks the authority to evaluate claims made on supplements' labels.  Only the Federal Trade Commission is authorized to do so.  

Unfortunately, the vast majority of consumers are unaware that the FDA has so little muscle when it comes to regulating supplements.  According to a Reality Coalition survey, 54% of patients think such products are FDA approved for safety, and 46% think they're approved for efficacy.

As Reality Coalition points out, the Hydroxycut recall is only the latest incident to highlight the inadequacies of DSHEA.  For instance, in 2004 the FDA banned the ingredient ephedra in supplements after thousands of  people using such products reported liver problems and other toxic events.  Ephedra was linked to fatalities, including that of a Baltimore Orioles pitcher Steve Bechler.

Recently, the FDA has gotten more aggressive in policing dietary supplements - especially in regards to undeclared ingredients.  In March, the agency sent letters to 72 companies regarding such ingredients, and many of the companies subsequently recalled their products.  

Unfortunately, because of the current provisions of  DSHEA, the FDA and the public do not become aware of  either side effects or dangerous, undeclared ingredients until a product has been on the market for sometime  - and possibly injures many consumers.  According to Reality Coalition, tragedies like those linked to Hydroxycut will continue to occur until DSHEA is reformed.

"Now is the ideal time for Congress . . . to raise the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products," Louis J. Aronne, M.D., co-chair of Reality Coalition, said in a statement.  "We firmly believe that there needs to be an FDA review process for all over-the-counter weight loss products."

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