Document ID: FDA-2010-D-0189-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy Concerning Regulations Restricting Sale and Distribution of Cigarettes and Smokeless Tobacco
Posted Date: 2010-05-07T04:00Z

[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25271-25272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10934]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0189]

Guidance for Industry and Food and Drug Administration Staff; 
Enforcement Policy Concerning Certain Regulations Restricting the Sale 
and Distribution of Cigarettes and 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 the guidance entitled ``Enforcement Policy Concerning 
Certain Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco.'' This guidance document discusses FDA's 
intended enforcement policies with respect to two provisions of the 
final regulations restricting the sale and distribution of cigarettes 
and smokeless tobacco to protect children and adolescents. One 
provision restricts the use of a trade or brand name of a nontobacco 
product as the trade or brand name for a cigarette or smokeless tobacco 
product. The second provision requires that labeling or print 
advertisements appear in a black-and-white text only format, except in 
certain ``adult only'' locations or in publications that do not have 
significant readership by children and adolescents under the age of 18. 
This guidance document will be implemented immediately, but it remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).

DATES: Submit 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 guidance 
document entitled ``Enforcement Policy Concerning Certain Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco'' 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 information on 
electronic access to the guidance.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments concerning this guidance 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: Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373, annette.marthaler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 25272]]

I. Background

    In the Federal Register of March 19, 2010 (75 FR 13225), FDA 
published final regulations restricting the sale and distribution of 
cigarettes and smokeless tobacco to protect children and adolescents. 
This guidance document discusses FDA's intended enforcement policies 
with respect to two provisions of the final regulations restricting the 
sale and distribution of cigarettes and smokeless tobacco to protect 
children and adolescents.
    One provision, Sec.  1140.16(a) (21 CFR 1140.16(a)), specifies that 
manufacturers may not use a trade or brand name of a nontobacco product 
as the trade or brand name for a cigarette or smokeless tobacco product 
unless the trade or brand name was on both the tobacco product and a 
nontobacco product sold in the United States on January 1, 1995. FDA is 
aware of concerns regarding this provision and is considering what 
changes, if any, would be appropriate to address those concerns.\1\ 
While FDA has this issue under consideration, it intends to exercise 
its enforcement discretion concerning Sec.  1140.16(a) (21 CFR 
1140.16(a)) not to commence enforcement actions under this provision 
for the duration of its consideration where:
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    \1\ Under section 102(a)(3)-(4) of the Family Smoking Prevention 
and Tobacco Control Act (21 U.S.C. 387a-1(a)(3)-(4)), FDA may amend 
the final rule after issuing a proposed rule for notice and comment.
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    (1) The trade or brand name of the cigarettes or smokeless tobacco 
product was registered, or the product was marketed, in the United 
States on or before June 22, 2009; or
    (2) The first marketing or registration in the United States of the 
tobacco product occurs before the first marketing or registration in 
the United States of the nontobacco product bearing the same name; 
provided, however, that the tobacco and nontobacco product are not 
owned, manufactured, or distributed by the same, related, or affiliated 
entities (including as a licensee).
    The second provision is Sec.  1140.32(a) (21 CFR 1140.32(a)). Under 
this section of the final rule, manufacturers, distributors, and 
retailers must use only black text on a white background for labeling 
or advertising (with certain exceptions). The United States District 
Court for the Western District of Kentucky recently issued an order 
permanently enjoining FDA from enforcing Sec.  1140.32(a) (formerly 21 
CFR 897.32(a) of the 1996 final rule that published in the Federal 
Register of August 28, 1996 (61 FR 44396)) (Commonwealth Brands, Inc. 
v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)). As 
required by section 102 of the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act), the effective date for Sec.  
1140.32(a) is June 22, 2010. At this time, however, in light of the 
court's order in Commonwealth Brands, FDA intends to exercise its 
enforcement discretion concerning Sec.  1140.32(a) not to commence 
enforcement actions under this provision during the pendency of the 
litigation irrespective of whether the entity is a party to the pending 
lawsuit or located in the Western District of Kentucky.
    FDA intends that the exercise of enforcement discretion expressed 
in this guidance document for Sec. Sec.  1140.16(a) and 1140.32(a) 
begin upon the effective date of the final rule (June 22, 2010). In 
accordance with FDA's GGP regulation (Sec.  10.115 (21 CFR 10.115)), 
you may comment on this guidance at any time. The agency will consider 
your comments and determine whether to revise the guidance at a later 
date.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's GGP regulation (Sec.  10.115). This guidance 
document is being implemented immediately without prior public comment 
under Sec.  10.115(g)(2) because the agency has determined that prior 
public participation is not feasible or appropriate. This document 
provides guidance on regulations that are required by statute (section 
102 of the Tobacco Control Act); moreover, the statute directs that the 
regulations take effect on June 22, 2010 (section 102(a)(2)(F) of the 
Tobacco Control Act). It is important that FDA explain its enforcement 
policy for these two provisions before that date.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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 the guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10934 Filed 5-5-10; 11:15 am]
BILLING CODE 4160-01-S