View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AI91 Publication ID: Spring 2024 
Title: ●Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition 
Abstract:

This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. 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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 190.1   
Legal Authority: secs. 201(ff)(3)(B), 301(ll)(2), and 701(a) of the Federal Food, Drug, and Cosmetic Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Gerie Voss
Director of Policy, Office of Dietary Supplement Programs
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition,
College Park, MD 20705
Phone:240 620-9744
Fax:301 595-1426
Email: gerie.voss@fda.hhs.gov