View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AI91 | Publication ID: Fall 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 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. |
|
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously 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:
|
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 Humans Foods Program, College Park, MD 20705 Phone:240 620-9744 Fax:301 595-1426 Email: gerie.voss@fda.hhs.gov |