[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Page 80828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32249]



[[Page 80828]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0575]


Draft Compliance Policy Guide Sec. 510.800 Beverages--Serving 
Size Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft ``Compliance Policy Guide Sec. 510.800 
Beverages--Serving Size Labeling'' (the draft CPG). The draft CPG, when 
finalized, will provide guidance for FDA staff on FDA's exercise of 
enforcement discretion related to serving size labeling for certain 
beverages that are packaged in containers larger than 20 fluid ounces 
and that display calories per 12 fluid ounce serving on the front of 
the container.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft CPG before it begins work on the final version of the CPG, submit 
either electronic or written comments on the draft CPG by February 22, 
2011.

ADDRESSES: Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments on the draft CPG to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written 
requests for single copies of the draft CPG to the Division of 
Compliance Policy (HFC-230), Office of Enforcement, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your 
request or fax your request to 240-632-6861. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft CPG.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft CPG is intended to provide guidance for FDA staff on the 
labeling of certain beverages. In particular, the draft CPG sets forth 
a policy to typically consider not taking an enforcement action when a 
beverage container larger than 20 fluid ounces states the calories per 
12 fluid ounces on the Principal Display Panel (PDP) and 
correspondingly provides the number of 12 fluid ounce servings in the 
container and the nutrition information is based on a 12 fluid ounce 
serving in the Nutrition Facts panel. FDA's labeling regulations 
require that the labeled serving size be based on Reference Amounts 
Customarily Consumed (RACC) (21 CFR 101.9(b) and Sec.  101.12(b) (21 
CFR 101.12(b))). The RACC for beverages is 240 milliliters (8 fluid 
ounces) (Sec.  101.12(b)). FDA's exercise of enforcement discretion is 
limited to the following beverages in containers that are larger than 
20 fluid ounces and that display calories on the PDP of the label per 
12 ounces: (1) Sports drinks (this term is used by industry and has not 
been defined by the Agency), (2) bottled water and water beverages, (3) 
soft drinks and diet soft drinks, (4) energy drinks (this term is used 
by industry and has not been defined by the Agency), and (5) ready-to-
drink teas. The CPG reflects the Agency's recent response to the 
American Beverage Association's request that FDA exercise enforcement 
discretion for industry to label certain beverages based on a 12 fluid 
ounce serving size (Refs. 1, 2, and 3). The draft CPG also contains 
information that may be useful to the regulated industry and to the 
public. FDA is issuing the draft CPG as level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft CPG, when finalized, will represent FDA's current 
thinking on the exercise of enforcement discretion for serving size 
labeling for the applicable beverages. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
FDA's Office of Regulatory Affairs history page at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter from Stuart M. Pape, Counsel to the American Beverage 
Association, May 27, 2010.
    2. Letter from Stuart M. Pape, Counsel to the American Beverage 
Association, June 24, 2010.
    3. Letter from Michael R. Taylor, Deputy Commissioner for Foods, 
FDA, July 12, 2010.

    Dated: December 13, 2010.
Dara Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2010-32249 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P