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HHS/FDA

RIN: 0910-AB97

Publication ID: Fall 1999

Title: ●Structure/Function
Abstract: The Food and Drug Administration (FDA) is issuing final regulations defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. The regulations also establish criteria for determining when a statement about a dietary supplement is a claim to diagnose, cure, mitigate, treat, or prevent disease. This action is intended to clarify what types of claims may be made for dietary supplements without prior review by FDA and what types of claims require prior authorization as health claims or prior approval as drug claims. Final rule establishing criteria for the types of statements that may be made for dietary supplements under 21 USC 343(r)(6) without prior FDA review.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Undetermined	Unfunded Mandates: No
CFR Citation: 21 CFR 101.93(g)
Legal Authority: 21 USC 343(r)(6) 21 USC 321(g) 21 USC 371(a)

Legal Deadline:

Action	Source	Description	Date
Final	Statutory

Timetable:

Action	Date	FR Cite
NPRM	04/29/1998	63 FR 23624
Notice of Public Meeting; Reopen. of comment period	07/08/1999	64 FR 36824
Final Action	01/00/2000

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses
Included in the Regulatory Plan: No
Agency Contact: Ann Marlin Witt Department of Health and Human Services Food and Drug Administration Office of the Commissioner, HF-11, 5600 Fishers Lane, Parklawn Bldg. rm. 14-101, Rockville, MD Phone:301 827-3360 Email: awitt@oc.fda.gov