[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32481-32482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0276]
Guidance for Industry: Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco; 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 a guidance for industry entitled ``Enforcement Policy
Concerning Rotational Warning Plans for Smokeless Tobacco Products.''
The guidance is intended to provide information relating to FDA's
enforcement policy concerning section 3 of the Comprehensive Smokeless
Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the
Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act). This guidance will be implemented immediately, but remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).
DATES: Submit either electronic or written comments on this guidance
at any time. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Enforcement Policy Concerning Rotational
Warning Plans for Smokeless Tobacco Products'' to the Center for
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229. Send one self-addressed adhesive label to
assist that office in processing your request or include a fax number
to which the guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 240-276-1717,
e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act grants FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect public health generally and to reduce
tobacco use by minors. Section 204 of the Tobacco Control Act amended
section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe
new requirements for health warning labels that must appear on
smokeless tobacco product packages and advertising, and to require that
rotational warning plans for packaging and advertising for smokeless
tobacco products be submitted to FDA, rather than to the Federal Trade
Commission (FTC).
The new warning labels required by section 3 of the Smokeless
Tobacco Act must begin to rotate in advertising for smokeless tobacco
products beginning on June 22, 2010, and must be distributed and
displayed on the packaging of smokeless tobacco products manufactured
on or after June 22, 2010, as set forth in section 3(b)(3) of the
Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and
section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after
July 22, 2010, manufacturers may not introduce any smokeless tobacco
product into
[[Page 32482]]
domestic commerce unless its packaging complies with section 3 of the
Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3)
is that the rotation of label statements on packaging and advertising
for each brand of smokeless tobacco must be ``in accordance with a plan
submitted by the tobacco product manufacturer, importer, distributor,
or retailer'' to, and approved by, FDA (Id.).
At this time, as an exercise of enforcement discretion, FDA does
not intend to commence or recommend enforcement of the requirement that
a smokeless tobacco manufacturer, distributor, importer, or retailer
must have an FDA-approved rotational warning plan, so long as a
rotational warning plan has been submitted to FDA by July 22, 2010. FDA
believes that allowing additional time for the review of rotational
warning plans will permit an orderly transition of regulatory authority
from FTC to FDA to review and approve rotational warning plans. During
such transition between June 22, 2010, and July 22, 2010, affected
companies may wish to contact FDA to discuss the submission of their
rotational warning plans in order to make the subsequent approval
process more orderly and efficient. FDA intends to provide further
public notice prior to revising or rescinding this enforcement policy
after the transition from FTC to FDA has been accomplished for the
submission and review of rotational warning plans. This enforcement
policy pertains only to the requirement that smokeless tobacco
manufacturers, distributors, importers, or retailers must have an FDA-
approved rotational warning plan. FDA expects compliance with regard to
all other requirements of section 3 of the Smokeless Tobacco Act,
including the requirements relating to size, formatting, location, and
use of required warning statements.
II. Significance of Guidance
FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulations (21 CFR
10.115). This guidance is being implemented immediately without prior
public comment under 10.115(g)(2) because the agency has determined
that prior public participation is not feasible or appropriate. This
document provides guidance on statutory provisions that take effect
June 22, 2010. It is important that FDA explain its enforcement policy
concerning the submission and approval of rotational warning plans for
smokeless tobacco products before that date.
III. 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.
IV. Electronic Access
An electronic version of this guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13819 Filed 6-4-10; 4:15 pm]
BILLING CODE 4160-01-S