[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