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HHS/FDA RIN: 0910-AF83 Publication ID: Spring 2006 
Title: ●Food Labeling; Nutrient Content Claims: Definition for "High Potency" and Definition of "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods(Section 610 Review) 
Abstract: Section 101.54 (21 CFR 101.54) describes the requirements for when the terms "high potency" and "antioxidant" may be used on the label or in the labeling of foods, including dietary supplements. Section 101.60 (21 CFR 101.60) describes the requirements for when the terms “low calorie” or “reduced calorie” may be used on the label or in the labeling of such foods. FDA is undertaking a review of sections 101.54 and 101.60 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in sections 101.54 and 101.60; (2) the nature of complaints or comments received concerning the regulations; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.54 and 101.60 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.54 and 101.60. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 101.54    21 CFR 101.60   
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 371   
Legal Deadline:
Action Source Description Date
Other  Statutory  Deadline for 610(c) Review  09/23/2007 
Action Date FR Cite
Begin Review  04/00/2006    
End Review  12/00/2006    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, Local, State, Tribal 
Federalism: Yes 
Included in the Regulatory Plan: No 
Agency Contact:
Richard A. Williams
Director, Division of Social Sciences, ORP, CFSAN
Department of Health and Human Services
Food and Drug Administration
HFS-725, Center for Food Safety and Applied Nutrition (HFS-725), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1989
Fax:301 436-2626

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