Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2017-N-0763] RIN 0910-AH43 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on ( printed page 50325) the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. DATES: Submit either electronic or written comments on the proposed rule by January 16, 2018. ADDRESSES: You may submit comments as follows. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit…
Other Federal Register documents from the same docket.
Citation: 82 FR 50324