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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.

 
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 
EO 13771 Designation: uncollected 
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
Timetable:
Action Date FR Cite
NPRM  10/00/2017 
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