[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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