2018-00683. Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment Period  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of October 31, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period on the proposed rule published on October 31, 2017 (82 FR 50324). Submit either electronic or written comments by March 19, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 19, 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 electronic comments in the following way:

    • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any Start Printed Page 2394confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-N-0763 for “Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Crystal Rivers, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1444.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of October 31, 2017, FDA published a proposed rule to revoke our 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 proposed 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 among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. We provided a 75-day comment period for the proposed rule.

    We have received requests for a 60-day extension of the comment period for the proposed rule. Each request conveyed concern that the current comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

    FDA has considered the requests and is extending the comment period for the proposed rule until March 19, 2018. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

    Start Signature

    Dated: January 11, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2018-00683 Filed 1-12-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
01/17/2018
Department:
Food and Drug Administration
Entry Type:
Proposed Rule
Action:
Proposed rule; extension of comment period.
Document Number:
2018-00683
Dates:
FDA is extending the comment period on the proposed rule published on October 31, 2017 (82 FR 50324). Submit either electronic or written comments by March 19, 2018.
Pages:
2393-2394 (2 pages)
Docket Numbers:
Docket No. FDA-2017-N-0763
RINs:
0910-AH43: Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
RIN Links:
https://www.federalregister.gov/regulations/0910-AH43/food-labeling-health-claims-soy-protein-and-coronary-heart-disease-
PDF File:
2018-00683.pdf
Supporting Documents:
» Reference_230 FDA_Tables of scientific evidence regarding the relationship between soy protein and CHD
» Reference_220 Rosell_2004_Soy intake and blood cholesterol concentrations-a cross-sectional study
» Reference_221 Sasazuki_2001_Case-control study of nonfatal myocardial infarction in relation to selected foods
» Reference_222 Yang_2005_Longitudinal study of soy food intake and blood pressure among middle-aged and elderly Chinese
» Reference_223 Zhang_2008_Greater habitual soyfood consumption is associated with decreased carotid intima-meida thickness
» Reference_224 Zhang_2003_Soy food consumption is associated with lower risk of coronary heart disease in Chinese
» Reference_225 Flegal_1999_Evaluating epidemiologic evidence of the effects of food and nutrient exposures
» Reference_226 Lichtenstein_2005_Essential nutrients_ food or supplements
» Reference_227 Peto_1981_Can dietary beta-carotene materially reduce human cancer rates
» Reference_228 The ATBC cancer prevention study group._1994_The effect of vitamin E and beta carotene on the incidence
CFR: (1)
21 CFR 101