[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22905-22906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0431]


Guidance for Food and Drug Administration Staff and Tobacco 
Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for 
Tobacco Retailers; 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 entitled ``Civil Money Penalties and No-
Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document 
describes FDA's current policies with respect to civil money penalties 
and no-tobacco-sale orders for retailers who violate requirements of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to 
tobacco products, including the FD&C Act requirement that tobacco 
products may not be sold or distributed in violation of FDA's 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents.'' With the 
release of this final guidance document, several provisions in the 
Family Smoking Prevention and Tobacco Control Act (the Tobacco Control 
Act) that relate to civil money penalties and no-tobacco-sale orders 
become effective.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco 
Retailers'' 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 document may 
be sent. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    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.

FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373, <a href="/cdn-cgi/l/email-protection#385f5d4a515d164e574b4b785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="99fefcebf0fcb7eff6eaead9fffdf8b7f1f1eab7fef6ef">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for FDA staff and 
tobacco retailers entitled ``Civil Money Penalties and No-Tobacco-Sale 
Orders for Tobacco Retailers.'' On June 22, 2009, President Obama 
signed the Tobacco Control Act (Pub. L. 111-31) into law. The Tobacco 
Control Act grants FDA important new authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
the public health generally and to reduce tobacco use by minors.
    Among its many provisions, the Tobacco Control Act authorizes FDA 
to impose civil money penalties for violations of the FD&C Act 
requirements that relate to tobacco products (section 303(f)(9) of the 
FD&C Act (21 U.S.C. 333(f)(9)). Of special interest to retailers, one 
of the FD&C Act's requirements is that tobacco products may not be sold 
or distributed in a manner that violates regulations issued under 
section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), such as the 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents'' that were 
published by FDA on March 19, 2010 (75 FR 13225) (21 CFR part 1140). 
The Tobacco Control Act also authorizes FDA to impose a no-tobacco-sale 
order on a retail outlet for repeated violations of regulations issued 
under section 906(d) of the FD&C Act, and discusses a number of 
technical and procedural issues relating to civil money penalties and 
no-tobacco-sale orders.
    This guidance document describes the penalty structure and FDA 
policies with respect to civil money policies and no-tobacco-sale 
orders. With the release of this final guidance document, several 
Tobacco Control Act provisions that relate to civil money penalties and 
no-tobacco-sale orders become effective (section 103(q)(3) of the 
Tobacco Control Act).
    In the Federal Register of August 31, 2010 (75 FR 53316), FDA 
announced the availability of the draft guidance of the same title 
dated August 2010. FDA received a few comments on the draft guidance, 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on ``Civil Money Penalties and No-
Tobacco-Sale Orders for Tobacco Retailers.'' 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 statute and regulations.

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.

[[Page 22906]]

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

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: April 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9938 Filed 4-22-11; 8:45 am]
BILLING CODE 4160-01-P


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