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HHS/FDA RIN: 0910-AH43 Publication ID: Fall 2017 
Title: Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease  

FDA is publishing a proposed rule revoking a 1999 regulation authorizing a health claim in food labeling concerning the benefits of soy protein intake on reducing the risk of coronary heart disease (CHD).  Under the law, a health claim is authorized by FDA regulation only when it is supported by scientific evidence that meets a statutory standard, the significant scientific agreement (SSA) standard.  In December 2007, FDA announced its intention to reevaluate the scientific evidence for this health claim and solicited additional scientific information and public comment.  We explained that we were reevaluating the scientific basis for this health claim because new studies not available in 1999 that had become available yielded varied and inconsistent findings that called into question whether the SSA standard was still met.  For example, the Agency for Healthcare Research and Quality (AHRQ) released a report in July 2005 outlining the effects of soy products on health outcomes including cardiovascular disease and concluded that soy products appear to exert a small benefit on LDL cholesterol. However, the AHRQ report also included studies that evaluated other soy components in addition to soy protein, and it was not clear whether soy protein or these other components that were responsible for lowering LDL cholesterol.  The proposed rule presents FDA’s evaluation of the currently available science and the tentative conclusion that it does not meet the SSA standard.

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: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
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
Action Date FR Cite
NPRM  11/00/2017 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Crystal Rivers
Department of Health and Human Services
Food and Drug Administration
5001 Campus Drive, HFS-830,
College Park, MD 20740
Phone:240 402-1450