[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32481-32482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13819]



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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.



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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: [email protected].



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