[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19620-19621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07925]
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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Draft Guidance for Industry: Proper Labeling of Honey and Honey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.
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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availability of a draft guidance for industry entitled ``Guidance for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 FDA developed this draft guidance to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 9, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements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access to the draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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FDA is announcing the availability of a draft guidance for industry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