Document ID: FDA-2006-P-0207-0011
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Proper Labeling of Honey and Honey
Products; Availability
Posted Date: 2014-04-09T04:00Z

[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19620-19621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07925]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry: Proper Labeling of Honey and Honey 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Guidance for 
Industry: Proper Labeling

[[Page 19621]]

of Honey and Honey Products.'' FDA developed this draft guidance to 
advise firms on the proper labeling of honey and honey products to help 
ensure that honey and honey products are not adulterated or misbranded.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 9, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements 
(HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., 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access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: April Kates, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Proper Labeling of Honey and Honey Products'' dated February 
2014. On March 8, 2006, the American Beekeeping Federation and several 
other honey-related associations submitted a citizen petition 
requesting that FDA adopt a U.S. standard of identity for honey based 
on the 2001 Revised Codex Alimentarius Commission's Standard for Honey. 
The petitioners asserted that a U.S. standard of identity for honey 
would achieve the following goals: (1) Clarify what the term ``honey'' 
means with respect to the food's composition and therefore promote 
honesty and fair dealing in the interest of consumers; (2) combat 
economic adulteration of honey by aiding enforcement and industry 
compliance; and (3) promote honesty and fair dealing within the food 
trade in general, where pure honey is used as an ingredient in other 
food. In a letter dated October 5, 2011, we denied the petition because 
the petition did not provide reasonable grounds for FDA to adopt the 
Codex standard for honey. We also concluded that the petitioners' goals 
can be achieved by FDA's existing authorities and that a standard of 
identity for honey would not promote honesty and fair dealing in the 
interest of consumers.
    To address the labeling issues relevant to the petition, we 
developed this draft guidance to advise the regulated food industry on 
the proper labeling of honey and honey products to help ensure that 
honey and honey products are not adulterated or misbranded under 
sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342 and 343, respectively).
    We are issuing this draft guidance document consistent with our 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent FDA's current thinking on the labeling 
of honey and honey products. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternate approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 101.4, 101.22, and 102 have been 
approved under OMB control number 0910-0381.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: April 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07925 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P