2010-13986. Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Use of ‘Light,’ ‘Mild,’ ‘Low,’ or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products.” This guidance provides information on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) requirements related to the use of “light,” “mild,” “low,” or similar descriptors in the label, labeling, or advertising of tobacco products. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices.

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 guidance document entitled “Use of ‘Light,’ ‘Mild,’ ‘Low,’ or Similar Descriptors in the Label, Labeling, or Advertising of 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 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:

Beth Buckler, Center for Tobacco Products,Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373, 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 the public health generally and to reduce tobacco use by minors. Section 911(b)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Tobacco Control Act, prohibits the use of the descriptors “light,” “mild,” or “low,” or similar descriptors on tobacco product labels, labeling, or advertising unless an FDA order is in effect for the product under section 911(g) of the act. Section 911(b)(3) of the act, as amended by the Tobacco Control Act, provides that section 911(b)(2)(A)(ii) shall take effect on June 22, 2010, and the effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 911(b)(2)(A)(ii). The guidance provides information in response to specific questions related to this provision. In accordance with FDA's good guidance practices regulation (§ 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 good guidance practices regulation (§ 10.115). This guidance document 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 guidance document provides information on statutory requirements that take effect on June 22, 2010 (section 911(b)(3) of the act). It is important that FDA provide this information 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 the guidance document is available on the Internet at http://www.regulations.gov and http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm.

Dated: June 7, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.