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| HHS/FDA | RIN: 0910-AF83 | Publication ID: Fall 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review is to determine whether the regulations should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities.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: Previously 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 | |
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Federal, Local, State, Tribal |
| Federalism: Yes | |
| Included in the Regulatory Plan: No | |
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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 Email: richard.williams@fda.hhs.gov |
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