DSHEA’s Failure: Why a Proactive Approach to Dietary Supplement Regulation Is Needed to Effectively Protect Consumers

In 1994, Congress enacted the Dietary Supplement Heath and Edu-cation Act (DSHEA), the first distinct regulatory scheme for dietary sup-plements sold in the United States. Although DSHEA is a congressional milestone as the first act to specifically address dietary supplements, it remains inadequate. DSHEA, as operated through the Food and Drug Administration (FDA), fails to adequately protect consumers from unsafe dietary supplements, such as ephedra, L-tryptophan, and Hydroxycut. Collectively, these dietary supplements have caused numerous illnesses and deaths. Under DSHEA manufacturers are required to report certain facts to the FDA, such as whether a new dietary ingredient is reasonably expected to be safe. Additionally, manufacturers are required to report serious adverse events associated with a dietary supplement. Until re-cently, however, the FDA retained the burden of proving that a dietary supplement was unreasonably risky. Consequently, dangerous products remained on the shelves for many years.The European Union’s Food Supplements Directive is much more restrictive than DSHEA. The Food Supplements Directive established a “positive list” that enumerates the permissible vitamins, minerals, and other ingredients permitted to be used in dietary supplements. This Note proposes that Congress amend DSHEA to incorporate several provisions of the Food Supplements Directive to better protect American consumers from the dangers associated with unsafe dietary supplements. The author argues that DSHEA limits the FDA’s ability to protect consumers and Congress should adopt an intermediate approach to dietary supplement restriction. This approach would implement additional premarketing re-quirements through a three-tier regulatory system, treating dietary sup-plements differently based on their marketing dates and potential risks. This regulatory scheme would strike a balance between consumer access and safety and would help prevent additional dietary supplement-related tragedies.

The full text of this Note is available to download as a PDF.