"Supplementing" the DSHEA: Congress Must Invest the FDA with Greater Regulatory Authority over Nutraceutical Manufacturers by Amending the Dietary Supplement Health and Education Act

15 Jul 2010 10:16am Rahi Azizi 

This paper addresses the serious deficiencies in the Dietary Supplement Health and Education Act, or "DSHEA." In it, I argue that the DSHEA (a federal statute passed by Congress in 1994, superseding the Food Drug and Cosmetics Act as the applicable law governing the sale of nutraceutical products) gives impermissible latitude to manufacturers of dietary supplements by allowing them to sell products without establishing whether they are safe or effective. The DSHEA also allows manufacturers to employ unsubstantiated and misleading labeling claims in marketing their products.

I assert that the DSHEA promotes deceptive labeling practices. I also suggest that the current regulatory regime is ineffective in assessing health risks posed by dietary supplements to the general public. I propose a way to amend the statute, by implementing a testing regime to better ensure both the safety and efficacy of supplements (comparable to, but distinguishable from and not nearly as stringent as the testing regime governing the distribution of pharmaceutical drugs). Furthermore, the paper advocates alleviating the burden the DSHEA imposes on the FDA in banning potentially dangerous supplements, by requiring courts to defer to FDA findings that a supplement is harmful (under the DSHEA, the FDA bears the burden of proof in showing that a supplement poses an "unreasonable or significant risk of harm" before removing it from the market; moreover, courts must apply de novo review to questions of law and fact in determining whether the FDA is justified in prohibiting the sale of a supplement). Additionally, I articulate a litigation strategy (based on California statutory law) that might incentivize enactment of an amendment by Congress. Alternative medicine implicates many controversial issues. The public's obsession with dietary supplements, despite the inadequacy of evidence demonstrating their benefits, is rather disturbing. I feel the government’s lack of regulation over this industry should be addressed (especially in light of the deaths linked to the herbal supplement ephedra, and the recent recall of the weigh-loss supplement Hydroxycut).

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