A Review and Critique of Safety Standards for Dietary Supplements

This is the authors' abstract. We don't add key points for this paper.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the Federal Food Drug and Cosmetic Act to establish standards concerning dietary supplements. Since 1994, additional amendments to the Federal Food Drug and Cosmetic Act have been added, focusing on adverse event reporting, Supplement Facts labels, current good manufacturing practices, and mandatory recall authority for dietary supplements. This article aims to review the current regulatory paradigm for dietary supplements containing dietary ingredients in the United States, address the positive and negative aspects of the current laws and regulations, and present potential improvements to DSHEA to meet the standard of reasonable certainty of safety for dietary supplements. While aspects of DSHEA have been beneficial, the expanse of technology in online marketing, sales, and manufacturing of dietary supplements has advanced since 1994. Regardless of the legal pathway, updates to DSHEA must address a risk-based safety standard, a publicly available listing of marketed dietary supplements in the United States, and a more efficient and robust mandatory US Federal Food and Drug Administration recall authority.