2010-13819. 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Submit written requests for single copies of the draft guidance document entitled “Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products” to the Center for Tobacco Products, Food and Drug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: [e-mail].

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 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.