DSHEA'S Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers
38 Pages Posted: 29 Jul 2009 Last revised: 17 Jun 2010
Date Written: May 10, 2010
In 1994, Congress codified a distinct regulatory scheme for dietary supplements after years of inconsistency. The Dietary Supplement and Health Education Act was enacted with the goal of increasing consumer access to 'safe' dietary supplements while giving the FDA the ability to remove unsafe dietary supplements from the market. Fifteen years later, DSHEA remains the law despite the health problems surrounding dietary supplements such as Ephedra, L-Tryptophan, and the recent Hydroxycut products. The primary problem with DSHEA is that it severely limits the FDA's ability to ban unsafe dietary supplements because it forces the FDA to regulate dietary supplements reactively instead of proactively. This Note analyzes DSHEA's limitations and compares the U.S. regulatory scheme with the recently enacted Food Supplements Directive of the European Union. The Note then offers an innovative solution to the regulatory problem that strikes a balance between the overly-restrictive Food Supplements Directive and the overly-inclusive Dietary Supplement and Health Education Act. This solution would strike a balance between consumer access and safety in order to protect from harmful dietary supplements like Ephedra.
Keywords: Dietary Supplement and Health Education Act, Food Supplements Directive, FDA, dietary supplements, classification, Food, Drug, and Cosmetic Act, Administrative Law, Ephedra, Hydroxycut, L-Tryptophan
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