This PDF is the current document as it appeared on Public Inspection on 03/01/2018 at 08:45 am.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Proper Labeling of Honey and Honey Products.” The guidance advises firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act.
The announcement of the guidance is published in the Federal Register on March 2, 2018.
You may submit either electronic or written comments on Agency guidances at any time as follows:
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”).
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-2006-P-0207 for “Proper Labeling of Honey and Honey Products.” 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 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 Start Printed Page 8997Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Andrea Krause, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.End Further Info End Preamble Start Supplemental Information
We are announcing the availability of a guidance for industry entitled “Proper Labeling of Honey and Honey Products.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
In the Federal Register of April 4, 2014 (79 FR 19620), we announced the availability of a draft guidance for industry entitled “Proper Labeling of Honey and Honey Products” and invited comment by June 9, 2014. We received numerous comments on the draft guidance and have modified the final guidance where appropriate. In addition, we made editorial changes to improve clarity and to focus on labeling issues. The final guidance recognizes a definition of honey that is broader than what was noted in the draft guidance and that reflects comments that said that bees use nectar from plants other than flowers. We declined, however, to further define “chief floral source” (as suggested by other comments) because it is addressed by the Compliance Policy Guide (CPG) 515.300, “Honey-Source Declaration” (available online at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074437.htm), and it is the responsibility of the producer to ensure that the source of its honey, if included on the label, is not false or misleading. In response to multiple comments asking us to clarify how flavored honey should be named, we revised the answer to this question to make it clear that honey with a characterizing flavor should be labeled in accordance with 21 CFR 101.3(b) and 102.5(a). The guidance announced in this notice finalizes the draft guidance dated April 2014.
II. Electronic Access
Persons with access to the internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.Start Signature
Dated: February 27, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-04282 Filed 3-1-18; 8:45 am]
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