[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Notices]
[Pages 71008-71009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0276]


Guidance for Industry: Enforcement Policy Concerning Rotational 
Warning Plans for Smokeless Tobacco Products; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a guidance entitled ``Enforcement Policy Concerning 
Rotational Warning Plans for Smokeless Tobacco Products,'' that was 
announced in the Federal Register on June 8, 2010.

DATES: The withdrawal is effective November 28, 2012.

FOR FURTHER INFORMATION CONTACT: Ele Ibarra-Pratt, Center for Tobacco 
Products, Office of Compliance and Enforcement, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-
287-1373, CTPCompliance@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On June 22, 2009, the President signed the 
Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) 
(Tobacco Control Act) into law. Section 204 of the Tobacco Control Act 
amended section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986 (Smokeless Tobacco Act), 15 U.S.C. 4402, to 
prescribe revised requirements for health warning statements that must 
appear on smokeless tobacco product packages and advertisements, and to 
require the submission of warning plans for smokeless tobacco product 
packages and advertisements to FDA for review and approval, rather than 
to the Federal Trade Commission (FTC). Section 3(b)(3) of the Smokeless 
Tobacco Act requires the equal distribution and display of warning 
statements on packaging, and the quarterly rotation of warning 
statements in advertising, for each brand of smokeless tobacco product 
``in accordance with a plan submitted by the tobacco product 
manufacturer, importer, distributor, or retailer'' to, and approved by, 
FDA. These requirements took effect on June 22, 2010.
    In a notice published in the Federal Register of June 8, 2010 (75 
FR 32481), FDA announced the availability of a guidance entitled 
``Enforcement Policy Concerning Rotational Warning Plans for Smokeless 
Tobacco Products.'' This guidance provided information to industry and 
the public, including that ``[a]t 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 believed that allowing additional time 
for the review of warning plans would permit an orderly transition of 
regulatory authority from the FTC to FDA to review and approve warning 
plans.

[[Page 71009]]

    FDA is withdrawing this guidance because it is no longer warranted. 
FDA has completed its review of all of the warning plans for smokeless 
tobacco products that were submitted to FDA by July 22, 2010, and the 
transition from FTC to FDA of the responsibility for reviewing warning 
plans for smokeless tobacco products has been accomplished. Further, 
this guidance included an incomplete definition of smokeless tobacco. 
Section 101(c) of the Tobacco Control Act amended the Smokeless Tobacco 
Act to give smokeless tobacco the meaning that term is given by section 
900(18) of the Federal Food, Drug, and Cosmetic Act. Under this 
definition, ``smokeless tobacco'' means any tobacco product that 
consists of cut, ground, powdered, or leaf tobacco and that is intended 
to be placed in the oral or nasal cavity. (Emphasis added) Thus, 
withdrawal of this guidance on enforcement policy will also help to 
prevent any confusion that may have been created by the misstatement of 
this definition.
    For information regarding the submission of warning plans for 
smokeless tobacco products, you may contact the Office of Compliance at 
FDA's Center for Tobacco Products (see FOR FURTHER INFORMATION 
CONTACT).
    We note that FDA has made available for public comment a draft 
guidance that, when finalized, will represent the Agency's current 
thinking on the ``Submission of Warning Plans for Cigarettes and 
Smokeless Tobacco Products.'' You can obtain an electronic version of 
this draft guidance document at either http://www.regulations.gov/ or 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. You can comment on 
this or any other guidance at any time.

    Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28809 Filed 11-27-12; 8:45 am]
BILLING CODE 4160-01-P