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HHS/FDA RIN: 0910-AB97 Publication ID: Spring 2000 
Title: Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body 
Abstract: On January 6, 2000, the Food and Drug Administration (FDA) issued 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 under 21 USC 343(r)(6). 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  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  01/06/2000  65 FR 00999   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
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