This PDF is the current document as it appeared on Public Inspection on 04/08/2014 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Guidance for Industry: Proper Labeling Start Printed Page 19621of Honey and Honey Products.” FDA developed this draft guidance to advise firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded.
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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 9, 2014.
Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of a draft guidance for industry entitled “Proper Labeling of Honey and Honey Products” dated February 2014.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.
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 AccessStart Signature
Dated: April 4, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-07925 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P