[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 8996-8997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04282]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-P-0207]


Proper Labeling of Honey and Honey Products; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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): 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

[[Page 8997]]

Staff, 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.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

    Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04282 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P