
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Proposed Rules]
[Pages 45465-45466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2015-D-1839]


The Food and Drug Administration's Policy on Declaring Small 
Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 45466]]


ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary 
Ingredients on Nutrition Labels: Guidance for Industry.'' The draft 
guidance, when finalized, will explain to manufacturers of conventional 
foods and dietary supplements our policy on determining the amount to 
declare on the nutrition label for certain nutrients and dietary 
ingredients that are present in a small amount.

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 the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 28, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist the 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access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carole Adler, 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

    We are announcing the availability of a draft guidance for industry 
entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and 
Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' We 
are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance represents the 
current thinking of FDA on our policy on declaring small amounts of 
nutrients and dietary ingredients on nutrition labels. 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.
    The draft guidance, when finalized, will explain our nutrition 
labeling policy on declaring the nutrient values in conventional foods 
and dietary ingredient values in dietary supplements in certain cases. 
Specifically, declaring small amounts of nutrients and dietary 
ingredients in the nutrition labeling may result in a conflict between 
21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 
101.9(g)(5). In such cases, we are recommending manufacturers declare 
nutrients and dietary ingredients in accordance with Sec.  101.9(c)(1) 
through (8). If the draft guidance is finalized, we intend to consider 
the use of our enforcement discretion with respect to the compliance 
requirements in Sec.  101.9(g)(4)(ii)) and Sec.  101.9(g)(5) when a 
conflict exists with Sec.  101.9(c)(1) through (8).
    We also are considering whether changes to our nutrition labeling 
regulations are needed, including changes to Sec.  101.9(c) or (g), or 
both. If we determine that rulemaking is needed, we will consider 
whether to revise or withdraw the draft guidance.

II. Paperwork Reduction Act of 1995

    The 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 Sec.  101.9 have been approved under OMB 
control number 0910-0381.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments 
regarding the draft guidance 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. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18655 Filed 7-29-15; 8:45 am]
 BILLING CODE 4164-01-P


