0910-AH43 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 101.71 21 CFR 101.82 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 No NPRM 10/00/2017 Undetermined Undetermined Undetermined No No Crystal Rivers Nutritionist 0910 Food and Drug Administration FDA 240 402-1450 crystal.rivers@fda.hhs.gov Humans Foods Program, 5001 Campus Drive, HFS-830, College Park MD 20740