83 FR 9000 - Reference Amounts Customarily Consumed: List of Products for Each Product Category; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Reference Amounts Customarily Consumed: List of Products for Each Product Category.'' The guidance provides examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in our regulations.

[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9000-9001]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4098]


Reference Amounts Customarily Consumed: List of Products for Each 
Product Category; Guidance for Industry; 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 ``Reference Amounts 
Customarily Consumed: List of Products for Each Product Category.'' The 
guidance provides examples of products that belong to product 
categories included in the tables of Reference Amounts Customarily 
Consumed (RACCs) per Eating Occasion established in our regulations.

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 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-2016-D-4098 for ``Reference Amounts Customarily Consumed: List of 
Products for Each Product Category.'' 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 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: Jillonne Kevala, 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

    We are announcing the availability of a guidance for industry 
entitled ``Reference Amounts Customarily Consumed: List of Products for 
Each Product Category.'' 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.
    This guidance is intended to help industry comply with the 
statutory requirement, under section 403(q)(1)(A)(i) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), 
that food that is intended for human consumption and offered for sale 
bear nutrition information that provides a serving size

[[Page 9001]]

that reflects the amount of food customarily consumed and is expressed 
in a common household measure that is appropriate to the food. To 
comply with this requirement, manufacturers must determine and label 
their food products with the appropriate label serving size based on 
the amount of the product customarily consumed.
    In the Federal Register of May 27, 2016, we issued a final rule 
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed at One Eating Occasion; Dual-Column Labeling; Updating, 
Modifying, and Establishing Certain Reference Amounts Customarily 
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81 
FR 34000). The final rule amends our regulations in Sec.  101.12(b) (21 
CFR 101.12(b)) to update or modify certain pre-existing RACCs, and to 
establish RACCs for new product categories.
    In the Federal Register of January 5, 2017 (82 FR 1344), we 
announced the availability of a draft guidance for industry entitled 
``Reference Amounts Customarily Consumed: List of Products for Each 
Product Category; Draft Guidance for Industry'' and gave interested 
parties an opportunity to submit comments by March 6, 2017, for us to 
consider before beginning work on the final version of the guidance. We 
received several comments on the draft guidance and have modified the 
content, where appropriate, for this final guidance. Changes to the 
guidance include the addition of flavored nut butter spreads (e.g., 
cocoa, cookie, and coffee flavored) as an example in the ``Nut and seed 
butters, pastes, or creams'' product category. In the Federal Register 
of November 2, 2016, we published a Request for Information and 
Comments requesting information and comments on the appropriate product 
category and RACC for flavored nut butter spreads (e.g., cocoa, cookie, 
and coffee flavored) (81 FR 76323). Based upon the information and 
comments received, and our own assessment, we have determined that 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) 
are comparable to nut butters and belong in the ``Nut and seed butters, 
pastes, or creams'' product category with a RACC of two tablespoons. In 
addition to this and other clarifying substantive changes that we made 
to the guidance, we made editorial changes to improve clarity and to 
help ensure consistency with Sec.  101.12(b). The guidance announced in 
this notice finalizes the draft guidance dated January 2017.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://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. 2018-04283 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P