[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25271-25272]
From the Federal Register Online via the Government Publishing 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, [email protected].
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