Director of Policy, Office of Dietary Supplement Programs

0910-AI91 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition

This proposed rule, if finalized, would find that a specific ingredient would not be excluded from the dietary supplement definition. Accordingly, products containing this ingredient could be lawfully marketed as dietary supplements, provided they otherwise meet the definition of "dietary supplement" under section 201(ff) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are not otherwise in violation of the FD&C Act. Section 201(ff) of the FD&C Act authorizes FDA, in its discretion, to issue a rule after notice and comment, finding that the article would be "lawful" under the FD&C Act. This proposed rule would also provide that the addition of this ingredient to a dietary supplement is not a prohibited act under section 301(ll) of the FD&C Act.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Deregulatory 21 CFR 190.1 secs. 201(ff)(3)(B), 301(ll)(2), and 701(a) of the Federal Food, Drug, and Cosmetic Act No NPRM 01/00/2026 Undetermined None No No No No Gerie Voss Director of Policy, Office of Dietary Supplement Programs 0910 Food and Drug Administration FDA 240 620-9744 301 595-1426 gerie.voss@fda.hhs.gov Humans Foods Program, College Park MD 20705