83_FR_9038 83 FR 8996 - Proper Labeling of Honey and Honey Products; Guidance for Industry; Availability

83 FR 8996 - Proper Labeling of Honey and Honey Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 42 (March 2, 2018)

Page Range8996-8997
FR Document2018-04282

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.

Federal Register, Volume 83 Issue 42 (Friday, March 2, 2018) 
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 8996-8997]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04282]


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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.

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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.thefederalregister.org/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

8996 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices The REAL ID Act of 2005 (Pub. L. DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for 109–13) establishes minimum standards HUMAN SERVICES written/paper submissions): Dockets for the issuance of state-issued driver’s Management Staff (HFA–305), Food and licenses and identification (ID) cards. It Food and Drug Administration Drug Administration, 5630 Fishers prohibits federal agencies from Lane, Rm. 1061, Rockville, MD 20852. [Docket No. FDA–2006–P–0207] • For written/paper comments accepting an official driver’s license or ID card from a state for any official Proper Labeling of Honey and Honey submitted to the Dockets Management purpose unless the Secretary of the Products; Guidance for Industry; Staff, FDA will post your comment, as Department of Homeland Security Availability well as any attachments, except for determines that the state meets these information submitted, marked and standards. Beginning October 2015, AGENCY: Food and Drug Administration, identified, as confidential, if submitted photo IDs (such as a valid driver’s HHS. as detailed in ‘‘Instructions.’’ license) issued by a state or territory not ACTION: Notice of availability. Instructions: All submissions received in compliance with the Real ID Act will must include the Docket No. FDA– SUMMARY: The Food and Drug 2006–P–0207 for ‘‘Proper Labeling of not be accepted as identification to enter Administration (FDA or we) is Honey and Honey Products.’’ Received federal buildings. Visitors from these announcing the availability of a comments will be placed in the docket states/territories will need to provide guidance for industry entitled ‘‘Proper and, except for those submitted as alternative proof of identification (such Labeling of Honey and Honey ‘‘Confidential Submissions,’’ publicly as a valid passport) to gain entrance into Products.’’ The guidance advises firms viewable at https://www.regulations.gov federal buildings. The current list of on the proper labeling of honey and or at the Dockets Management Staff states from which a federal agency may honey products to help ensure that between 9 a.m. and 4 p.m., Monday accept driver’s licenses for an official honey and honey products are not through Friday. purpose is found at http://www.dhs.gov/ adulterated or misbranded under the • Confidential Submissions—To real-id-enforcement-brief. Federal Food, Drug, and Cosmetic Act. submit a comment with confidential We recommend that confirmed DATES: The announcement of the information that you do not wish to be registrants arrive reasonably early, but guidance is published in the Federal made publicly available, submit your no earlier than 45 minutes prior to the Register on March 2, 2018. comments only as a written/paper start of the meeting, to allow additional ADDRESSES: You may submit either submission. You should submit two time to clear security. Security measures electronic or written comments on copies total. One copy will include the include the following: Agency guidances at any time as information you claim to be confidential follows: with a heading or cover note that states • Presentation of a government-issued ‘‘THIS DOCUMENT CONTAINS photographic identification to the Electronic Submissions CONFIDENTIAL INFORMATION.’’ We Federal Protective Service or Guard Submit electronic comments in the will review this copy, including the Service personnel. following way: claimed confidential information, in our • Inspection, via metal detector or • Federal eRulemaking Portal: consideration of comments. The second other applicable means, of all persons https://www.regulations.gov. Follow the copy, which will have the claimed entering the building. We note that all instructions for submitting comments. confidential information redacted/ items brought into HHH Building, Comments submitted electronically, blacked out, will be available for public whether personal or for the purpose of including attachments, to https:// viewing and posted on https:// presentation or to support a www.regulations.gov will be posted to www.regulations.gov. Submit both presentation, are subject to inspection. the docket unchanged. Because your copies to the Dockets Management Staff. We cannot assume responsibility for comment will be made public, you are If you do not wish your name and coordinating the receipt, transfer, solely responsible for ensuring that your contact information to be made publicly transport, storage, set up, safety, or comment does not include any available, you can provide this confidential information that you or a information on the cover sheet and not timely arrival of any personal third party may not wish to be posted, in the body of your comments and you belongings or items used for such as medical information, your or must identify this information as presentation or to support a ‘‘confidential.’’ Any information marked presentation. anyone else’s Social Security number, or confidential business information, such as ‘‘confidential’’ will not be disclosed Note: Individuals who are not registered in as a manufacturing process. Please note except in accordance with 21 CFR 10.20 advance will not be permitted to enter the that if you include your name, contact and other applicable disclosure law. For building and will be unable to attend the information, or other information that more information about FDA’s posting meeting. identifies you in the body of your of comments to public dockets, see 80 comments, that information will be FR 56469, September 18, 2015, or access Authority: 42 U.S.C. 217a, sec. 222 of the the information at: https://www.gpo.gov/ posted on https://www.regulations.gov. Public Health Service Act, as amended; 42 • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- U.S.C. 1314(f), sec. 1114(f) of the Social 23389.pdf. with confidential information that you Security Act; and Public Law 92–463, as do not wish to be made available to the Docket: For access to the docket to amended (5 U.S.C. App. 2); 41 CFR 102–3. public, submit the comment as a read background documents or the daltland on DSKBBV9HB2PROD with NOTICES Dated: February 21, 2018. written/paper submission and in the electronic and written/paper comments Seema Verma, manner detailed (see ‘‘Written/Paper received, go to https:// Administrator, Centers for Medicare & Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the Medicaid Services. docket number, found in brackets in the Written/Paper Submissions heading of this document, into the [FR Doc. 2018–04328 Filed 3–1–18; 8:45 am] Submit written/paper submissions as ‘‘Search’’ box and follow the prompts BILLING CODE 4120–01–P follows: and/or go to the Dockets Management VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1

Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 8997 Staff, 5630 Fishers Lane, Rm. 1061, asking us to clarify how flavored honey instructions for submitting comments. Rockville, MD 20852. should be named, we revised the answer Comments submitted electronically, You may submit comments on any to this question to make it clear that including attachments, to https:// guidance at any time (see 21 CFR honey with a characterizing flavor www.regulations.gov will be posted to 10.115(g)(5)). should be labeled in accordance with 21 the docket unchanged. Because your Submit written requests for single CFR 101.3(b) and 102.5(a). The guidance comment will be made public, you are copies of the guidance to the Office of announced in this notice finalizes the solely responsible for ensuring that your Nutrition and Food Labeling, Center for draft guidance dated April 2014. comment does not include any Food Safety and Applied Nutrition, confidential information that you or a II. Electronic Access third party may not wish to be posted, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Persons with access to the internet such as medical information, your or Send two self-addressed adhesive labels may obtain the guidance at either http:// anyone else’s Social Security number, or to assist that office in processing your www.fda.gov/FoodGuidances or https:// confidential business information, such request. See the SUPPLEMENTARY www.regulations.gov. Use the FDA as a manufacturing process. Please note INFORMATION section for electronic website listed in the previous sentence that if you include your name, contact access to the guidance. to find the most current version of the information, or other information that FOR FURTHER INFORMATION CONTACT: guidance. identifies you in the body of your Andrea Krause, Center for Food Safety Dated: February 27, 2018. comments, that information will be and Applied Nutrition, Food and Drug posted on https://www.regulations.gov. Leslie Kux, Administration, 5001 Campus Dr., • If you want to submit a comment Associate Commissioner for Policy. with confidential information that you College Park, MD 20740, 240–402–2371. [FR Doc. 2018–04282 Filed 3–1–18; 8:45 am] do not wish to be made available to the SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P public, submit the comment as a I. Background written/paper submission and in the manner detailed (see ‘‘Written/Paper We are announcing the availability of DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). a guidance for industry entitled ‘‘Proper HUMAN SERVICES Labeling of Honey and Honey Written/Paper Submissions Products.’’ We are issuing this guidance Food and Drug Administration Submit written/paper submissions as consistent with our good guidance [Docket No. FDA–2016–D–3401] follows: practices regulation (21 CFR 10.115). • Mail/Hand delivery/Courier (for The guidance represents the current Scientific Evaluation of the Evidence written/paper submissions): Dockets thinking of FDA on this topic. It does on the Beneficial Physiological Effects Management Staff (HFA–305), Food and not establish any rights for any person of Isolated or Synthetic Non-Digestible Drug Administration, 5630 Fishers and is not binding on FDA or the public. Carbohydrates Submitted as a Citizen Lane, Rm. 1061, Rockville, MD 20852. You can use an alternative approach if Petition; Guidance for Industry; • For written/paper comments it satisfies the requirements of the Availability submitted to the Dockets Management applicable statutes and regulations. This Staff, FDA will post your comment, as guidance is not subject to Executive AGENCY: Food and Drug Administration, well as any attachments, except for Order 12866. HHS. information submitted, marked and In the Federal Register of April 4, ACTION: Notification of availability. identified, as confidential, if submitted 2014 (79 FR 19620), we announced the as detailed in ‘‘Instructions.’’ availability of a draft guidance for SUMMARY: The Food and Drug Instructions: All submissions received industry entitled ‘‘Proper Labeling of Administration (FDA or we) is must include the Docket No. FDA– Honey and Honey Products’’ and announcing the availability of a 2016–D–3401 for ‘‘Scientific Evaluation invited comment by June 9, 2014. We guidance for industry entitled of the Evidence on the Beneficial received numerous comments on the ‘‘Scientific Evaluation of the Evidence Physiological Effects of Isolated or draft guidance and have modified the on the Beneficial Physiological Effects Synthetic Non-Digestible Carbohydrates final guidance where appropriate. In of Isolated or Synthetic Non-Digestible Submitted as a Citizen Petition (21 CFR addition, we made editorial changes to Carbohydrates Submitted as a Citizen 10.30).’’ Received comments will be improve clarity and to focus on labeling Petition (21 CFR 10.30).’’ The guidance placed in the docket and, except for issues. The final guidance recognizes a describes our views on the scientific those submitted as ‘‘Confidential definition of honey that is broader than evidence needed and the approach to Submissions,’’ publicly viewable at what was noted in the draft guidance evaluating the scientific evidence on the https://www.regulations.gov or at the and that reflects comments that said that physiological effects to human health of Dockets Management Staff between 9 bees use nectar from plants other than isolated or synthetic non-digestible a.m. and 4 p.m., Monday through flowers. We declined, however, to carbohydrates that are added to foods. Friday. further define ‘‘chief floral source’’ (as DATES: The announcement of the • Confidential Submissions—To suggested by other comments) because it guidance is published in the Federal submit a comment with confidential is addressed by the Compliance Policy Register on March 2, 2018. information that you do not wish to be Guide (CPG) 515.300, ‘‘Honey-Source ADDRESSES: You may submit electronic made publicly available, submit your Declaration’’ (available online at http:// or written comments on Agency comments only as a written/paper daltland on DSKBBV9HB2PROD with NOTICES www.fda.gov/iceci/compliancemanuals/ guidances at any time as follows: submission. You should submit two compliancepolicyguidancemanual/ copies total. One copy will include the ucm074437.htm), and it is the Electronic Submissions information you claim to be confidential responsibility of the producer to ensure Submit electronic comments in the with a heading or cover note that states that the source of its honey, if included following way: ‘‘THIS DOCUMENT CONTAINS on the label, is not false or misleading. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The In response to multiple comments https://www.regulations.gov. Follow the Agency will review this copy, including VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1


Document Created: 2018-03-01 23:57:09
Document Modified: 2018-03-01 23:57:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on March 2, 2018.
ContactAndrea Krause, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
FR Citation83 FR 8996 
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