Regulation of Herbal Dietary Supplements: Is There a Better Way?

Abstract

This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and post-DSHEA enforcement actions. This review also addresses international aspects of dietary supplement regulatory processes. The controversy surrounding the separation of structure/function claims from health claims is examined. Safety issues are summarized and the following proposals are offered to improve the herbal dietary supplements regulatory system. First, herbal dietary supplements should be subject to more strict regulation by the FDA, which means treating them more like pharmaceuticals and not like food. Only pre-market approval can guarantee consumer access to safe and effective product. Second, a suggested simplified procedure allows the registration of a traditional herbal dietary supplement. Third, due to the compositional diversity and complexity of botanical substances, every new submission of nontraditional herbal supplement must be processed on a case-by-case basis. Fourth, a mandatory post-marketing reporting system of all adverse events should be established rather than the current serious adverse event reporting scheme. And finally, legislative reform is needed to change the regulatory system of dietary supplements.

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Correspondence to Irwin G. Martin PhD.

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Zakaryan, A., Martin, I.G. Regulation of Herbal Dietary Supplements: Is There a Better Way?. Ther Innov Regul Sci 46, 532–544 (2012). https://doi.org/10.1177/0092861512452121

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Keywords

  • dietary supplements
  • herbals
  • regulation
  • safety
  • law