Document ID: FDA-2010-D-0276-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco; Availability
Posted Date: 2010-06-08T04:00Z

[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]               
[Page 32481-32482]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-106]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0276]

 
Guidance for Industry: Enforcement Policy Concerning Rotational 
Warning Plans for Smokeless Tobacco; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Enforcement Policy 
Concerning Rotational Warning Plans for Smokeless Tobacco Products.'' 
The guidance is intended to provide information relating to FDA's 
enforcement policy concerning section 3 of the Comprehensive Smokeless 
Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the 
Family Smoking Prevention and Tobacco Control Act (Tobacco Control 
Act). This guidance will be implemented immediately, but remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).

DATES:  Submit either 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Enforcement Policy Concerning Rotational 
Warning Plans for Smokeless Tobacco Products'' 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 may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to guidance.
    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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco 
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 240-276-1717, 
e-mail: Gail.Schmerfeld@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-31) into law. The Tobacco Control Act grants FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect public health generally and to reduce 
tobacco use by minors. Section 204 of the Tobacco Control Act amended 
section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe 
new requirements for health warning labels that must appear on 
smokeless tobacco product packages and advertising, and to require that 
rotational warning plans for packaging and advertising for smokeless 
tobacco products be submitted to FDA, rather than to the Federal Trade 
Commission (FTC).
    The new warning labels required by section 3 of the Smokeless 
Tobacco Act must begin to rotate in advertising for smokeless tobacco 
products beginning on June 22, 2010, and must be distributed and 
displayed on the packaging of smokeless tobacco products manufactured 
on or after June 22, 2010, as set forth in section 3(b)(3) of the 
Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and 
section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after 
July 22, 2010, manufacturers may not introduce any smokeless tobacco 
product into

[[Page 32482]]

domestic commerce unless its packaging complies with section 3 of the 
Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3) 
is that the rotation of label statements on packaging and advertising 
for each brand of smokeless tobacco must be ``in accordance with a plan 
submitted by the tobacco product manufacturer, importer, distributor, 
or retailer'' to, and approved by, FDA (Id.).
    At 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 
believes that allowing additional time for the review of rotational 
warning plans will permit an orderly transition of regulatory authority 
from FTC to FDA to review and approve rotational warning plans. During 
such transition between June 22, 2010, and July 22, 2010, affected 
companies may wish to contact FDA to discuss the submission of their 
rotational warning plans in order to make the subsequent approval 
process more orderly and efficient. FDA intends to provide further 
public notice prior to revising or rescinding this enforcement policy 
after the transition from FTC to FDA has been accomplished for the 
submission and review of rotational warning plans. This enforcement 
policy pertains only to the requirement that smokeless tobacco 
manufacturers, distributors, importers, or retailers must have an FDA-
approved rotational warning plan. FDA expects compliance with regard to 
all other requirements of section 3 of the Smokeless Tobacco Act, 
including the requirements relating to size, formatting, location, and 
use of required warning statements.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulations (21 CFR 
10.115). This guidance is being implemented immediately without prior 
public comment under 10.115(g)(2) because the agency has determined 
that prior public participation is not feasible or appropriate. This 
document provides guidance on statutory provisions that take effect 
June 22, 2010. It is important that FDA explain its enforcement policy 
concerning the submission and approval of rotational warning plans for 
smokeless tobacco products before that date.

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. 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

    An electronic version of this guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13819 Filed 6-4-10; 4:15 pm]
BILLING CODE 4160-01-S