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HHS/FDA | RIN: 0910-AH43 | Publication ID: Spring 2017 |
Title: Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease | |
Abstract:
FDA is proposing to amend its regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. Under the FD&C Act "health claims," which characterize the relationship of a food to a disease or health-related condition, must be authorized by FDA before they can be used. The science supporting this claim is not sufficient to meet the statutory standard for FDA authorization, but there is some evidence supporting a soy protein benefit on coronary heart disease that FDA would allow as discussed in its guidance documents: 1) FDA's Implementation of Qualified Health Claims; Questions; and Answers and 2) Evidence-Based Review System for the Scientific Evaluation of Health Claims. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 101.71 21 CFR 101.82 | |
Legal Authority: 15 U.S.C. 1453 to 1455 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 342 to 343 21 U.S.C. 348 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Crystal Rivers Nutritionist Department of Health and Human Services Food and Drug Administration 5001 Campus Drive, HFS-830, College Park, MD 20740 Phone:240 402-1450 Email: crystal.rivers@fda.hhs.gov |