[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Rules and Regulations]
[Pages 6045-6046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification 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 ``Food Labeling: 
Revision of the Nutrition and Supplement Facts Labeling--Small Entity 
Compliance Guide.'' The small entity compliance guide (SECG) is 
intended to help small entities comply with a final rule we issued in 
the Federal Register of May 27, 2016, entitled ``Food Labeling: 
Revision of the Nutrition and Supplement Facts Labeling.''

DATES: The announcement of the guidance is published in the Federal 
Register on February 4, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA 
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-2012-N-1210 for ``Food Labeling: Revision of the Nutrition and 
Supplement Facts Labeling--Small Entity Compliance Guide.'' 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.govinfo.gov/content/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 Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the SECG to the Office 
of Nutrition and Food Labeling, Center for Food Safety and Applied 
Nutrition (HFS-800), 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 SECG.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 27, 2016 (81 FR 33742), we issued a 
final rule amending our labeling regulations for conventional foods and 
dietary supplements to provide updated nutrition information on the 
label to assist consumers in maintaining healthy dietary practices. The 
final rule updates the list of nutrients that are required or permitted 
to be declared; provides updated Daily Reference Values and Reference 
Daily Intake values that are based on updated dietary recommendations 
from consensus reports; amends requirements for foods represented or 
purported to be specifically for children under the age of 4 years and 
pregnant and lactating women and establishes nutrient reference values 
specifically for these population subgroups; and revises the format and 
appearance of the Nutrition Facts label. The final rule, which is 
codified at 21 CFR 101.9, 101.30, and 101.36, became effective July 26, 
2016, and set a compliance date of July 26, 2018, for manufacturers 
with $10 million or more in annual food sales, and July 26, 2019, for 
manufacturers

[[Page 6046]]

with less than $10 million in annual food sales. In the Federal 
Register of May 4, 2018 (83 FR 19619), we published a final rule to 
extend the compliance dates to January 1, 2020, for manufacturers with 
$10 million or more in annual food sales, and January 1, 2021, for 
manufacturers with less than $10 million in annual food sales.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rules on nutrition labeling, taken as a whole, will have 
a significant economic impact on a substantial number of small 
entities. In compliance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by 
Pub. L. 110-28), we are making available the SECG to explain the 
actions that a small entity must take to comply with the rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG 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.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
Sec. Sec.  101.9, 101.30, and 101.36 have been approved under OMB 
control number 0910-0813.

III. Electronic Access

    Persons with access to the internet may obtain the SECG 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: January 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01165 Filed 2-3-20; 8:45 am]
BILLING CODE 4164-01-P


