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HHS/FDA RIN: 0910-AF83 Publication ID: Spring 2008 
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(Completion of a Section 610 Review) 
Abstract: Section 101.54 (21 CFR part 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 part 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 undertook a review of sections 101.54 and 101.60 under section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities.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 solicited 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. No comments were received. FDA's review of these regulations concluded that they should be continued without change. 
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 
RFA Section 610 Review: Completion of a 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 
Timetable:
Action Date FR Cite
Begin Review  12/01/2006   
End Review  11/30/2007   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State, Tribal 
Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
David Zorn
Lead Economist
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, ORP (HFS-020), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1825
Fax:301 436-2505
Email: david.zorn@fda.hhs.gov

 
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