
[Federal Register: August 31, 2010 (Volume 75, Number 168)]
[Notices]               
[Page 53316-53317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au10-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Food and Drug Administration Staff and Tobacco 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availability of a draft guidance entitled ``Civil Money Penalties and 
No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document 
is intended to describe 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.'' When this 
guidance document is final, several provisions in the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) that relate to 
civil money penalties and no-tobacco-sale orders will become effective.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 1, 2010.

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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://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, gerie.voss@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 (Public Law 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 FD&C Act requirements 
that relate to tobacco products (section 303(f)(9) of the FD&C Act (21 
U.S.C. 333

[[Page 53317]]

(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, such as the ``Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco to Protect Children 
and Adolescents'' that were published by FDA in the Federal Register of 
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.
    The draft guidance document describes the penalty structure and 
draft FDA policies with respect to civil money policies and no-tobacco-
sale orders. When this guidance is final, several Tobacco Control Act 
provisions that relate to civil money penalties and no-tobacco-sale 
orders will become effective (section 103(q)(3) of the Tobacco Control 
Act).

II. Significance of Guidance

    FDA is issuing this draft guidance document as a level 1 draft 
guidance consistent with FDA's good guidance practices regulation 
(Sec.  10.115 (21 CFR 10.115)). The draft guidance, when finalized, 
will represent 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), 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

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

    Dated: August 26, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21661 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-01-S

