E9-28747. Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Listing of Ingredients in Tobacco Products.” The guidance document is intended to assist persons making tobacco product ingredient submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

DATES:

Submit written or electronic 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 “Listing of Ingredients in 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 document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Michele Mital, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 301-796-4800, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 3, 2009 (74 FR 56842), FDA announced the availability of a draft guidance document entitled “Listing of Ingredients in Tobacco Products.” The agency considered received comments as it finalized this guidance. This guidance document is designed to assist tobacco product manufacturers and importers with making tobacco product ingredient submissions to FDA. Under section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, each tobacco product manufacturer or importer, or agent thereof, is required to submit “a listing of all ingredients, including tobacco, substances, compounds, and additives that are * * * added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.” For tobacco products on the market as of June 22, 2009, information must be submitted to FDA by December 22, 2009, and include the ingredients added as of the date of submission. FDA does not, however, intend to enforce the statutory deadline of this subsection provided the ingredient list is submitted on or before June 22, 2010. For tobacco products not on the market as of June 22, 2009, section 904(c)(1) requires that the list of ingredients be submitted at least 90 days prior to delivery for introduction into interstate commerce. Section 904(c) of the act also requires submission of information whenever additives, or the quantities of additives, are changed. FDA does not, however, intend to enforce the statutory deadlines for ingredient reporting under section 904(c) of the act for additive changes or the initial introduction of products into interstate commerce occurring between June 22, 2009, and 90 days after the section 904(a)(1) ingredient list is submitted, provided that these report(s) are submitted at the time of the section 904(a)(1) submission and the report(s) include the date, or planned date, of making the change to the additive or introducing the product into interstate commerce.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “Listing of Ingredients in Tobacco Products.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic 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. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0650.

V. 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: November 25, 2009.

David Horowitz,

Assistant Commissioner for Policy.