CRN is examining revisions to the drug preclusion provision, advocating for changes in FDA’s interpretation, and advocating for Congress to revise the section to clarify its limited scope. CRN is addressing impacts on specific ingredients and its application generally to the supplement marketplace. Addressing drug preclusion is one of CRN's 2023 policy priorities.
Key links: CRN Challenges FDA Course on Drug Preclusion
May 2023: CRN Citizen Petition requesting FDA reconsider its position with respect to the application of section 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act; acknowledge that agency prior statements and actions cannot be reversed on drug preclusion grounds; and clarify its position on rulemaking
Selected related publications:
“Given the consistently overly broad manner in which the FDA has interpreted the drug preclusion provision since its inception, amending the drug preclusion language may be the best option to preserve consumer access to dietary supplements. A few changes to the drug preclusion clause could help align the language with what the authors of this article understand was the original intent of drug preclusion and still ensure that drug research and development are protected, and unscrupulous companies are limited in using supplements to bypass drug approval.”
—CRN General Counsel & SVP Megan Olsen in Regulatory Focus, 2022, "Drug preclusion and public health: The case for a narrow interpretation of ‘article’"
“An obscure provision of the Dietary Supplement Health and Education Act (DSHEA). Section 201(ff)(3)(B) of the Food Drug & Cosmetic (FD&C) Act (codified at 21 USC 321(ff)(3)(B))—sometimes called the 'drug preclusion provision'—is increasingly used to prevent or remove safe and legitimate dietary ingredients from the market. It’s time to change that.”
—CRN President & CEO Steve Mister in Natural Products Insider, 2021, "The dietary supplement industry’s drug preclusion predicament"