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HHS/FDA RIN: 0910-AA59 Publication ID: Fall 1997 
Title: Dietary Supplement Regulations in Response to DSHEA 
Abstract: On January 4, 1994, FDA published final rules relative to nutrition labeling, nutrient content claims and health claims for dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) was enacted on October 25, 1994, modifying the provisions for labeling of dietary supplements. FDA has initiated rulemaking to modify its regulations for dietary supplements accordingly. One proposal would modify the nutrition labeling and ingredient declaration requirements. A second proposal would provide for the use of nutrient content claims and health claims on dietary supplements and establish procedures for the use of a disclaimer to accompany statements of nutritional support. A third proposal would define the terms "high potency" and "antioxidant." These three proposals were published in the Federal Register on December 28, 1995. An ANPRM was published in February 1997 seeking public comments on issues related to the establishment of current good manufacturing practices for dietary supplements. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 101   
Legal Authority: 15 USC 1453    15 USC 1454    15 USC 1455    21 USC 321    21 USC 331    21 USC 342    21 USC 343    21 USC 348    21 USC 351    21 USC 352    21 USC 355    21 USC 371   

Timetable:
Action Date FR Cite
NPRM  To Be Determined    
Child RIN List:
RIN Title
0910-AE73 CGMPs in the Manufacturing, Packing, or Holding of Dietary Supps.
0910-AE65 High Potency and Antioxidant Terms; Dietary Supplements
0910-AE64 Nutrient Content and Health Claim; Dietary Supplements
0910-AE67 Nutrient Content and Health Claims; Dietary Supplements
0910-AE71 Nutrient Labeling and Ingredient Labeling; Dietary Supplements
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: No 
Agency Contact:
Betty Campbell
Acting Director, Office of Food Labeling
Department of Health and Human Services
Food and Drug Administration
HFS-150, Center for Food Safety and Applied, Nutrition, 200 C Street SW.,
Washington, DC 20204
Phone:202 205-4561