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Parent RIN:   0910-AA59
HHS/FDA RIN: 0910-AE65 Publication ID: Fall 1999 
Title: High Potency and Antioxidant Terms; Dietary Supplements 
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 statutory provisions governing 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. FDA published three final rules on September 23, 1997, responding to the proposals of December 28, 1995, and entitled: (1) "Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation;" (2) "Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements;" and (3) "Food Labeling; Nutrient Content Claims: Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods." The agency received several petitions for reconsideration of aspects of the final rule on nutrition labeling and ingredient declaration for dietary supplements. In response to these petitions, FDA published a final rule revising the nutrition labeling requirements for dietary supplements that contain liquid or dried extracts. DSHEA also established an independent agency within the Executive Branch known as the Commission on Dietary Supplement Labels. The Commission was charged with conducting a study on, and providing recommendations for, regulating label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for evaluating such claims. On November 24, 1997, the Commission's final report was released. On April 29, 1998, FDA issued a notice on its views on the Commission's report and a proposed rule that responds to guidance in the report concerning statements about the effect of dietary supplements on the structure or function of the body. 
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   
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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/28/1995  60 FR 67184   
Comment Period End  06/10/1996    
Final Rule  09/23/1997  62 FR 49808   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: No 
Agency Contact: