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Proposed Rule

Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period

This document has a comment period that ends in 100 days. (04/26/2017) Submit a formal comment

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term “healthy” in the labeling of human food products. We established the docket through a notice that appeared in the Federal Register of September 28, 2016. In the notice, we requested comments on the term “healthy”, generally, and as a nutrient content claim in the context of food labeling; we also requested comments on specific questions contained in the notice. 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 notice that published in the Federal Register of September 28, 2016 (81 FR 66562). Submit either electronic or written comments by April 26, 2017.

ADDRESSES:

You may submit comments as follows:

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 confidential 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2016-D-2335 for “Use of the Term 'Healthy' in the Labeling of Human Food Products; Request for Information and Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Start Printed Page 96405comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.

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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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FOR FURTHER INFORMATION CONTACT:

Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.

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SUPPLEMENTARY INFORMATION:

In the Federal Register of September 28, 2016, we published a notice announcing the establishment of a docket to receive information and comments on the use of the term “healthy” in the labeling of human food products. The notice discussed FDA's position regarding the use of the term “healthy”, the events that prompted us to establish a docket to request information and comments on this issue, and specific issues for consideration. We provided a 120-day comment period that was scheduled to end on January 26, 2017.

We have received requests to extend the comment period. The requests conveyed concern that the current 120-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the questions and issues we presented in the notice.

We have considered the requests and are extending the comment period for 90 days, until April 26, 2017. We believe that a 90-day extension allows adequate time for interested persons to submit comments.

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Dated: December 27, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-31734 Filed 12-29-16; 8:45 am]

BILLING CODE 4164-01-P