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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was to determine whether the regulations should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities.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:
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Timetable:
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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 |