[Federal Register Volume 74, Number 229 (Tuesday, December 1, 2009)]
[Notices]
[Pages 62795-62796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0524]


Guidance for Industry on Listing of Ingredients in Tobacco 
Products; 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 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, [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 62796]]

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announced the availability of a draft guidance document entitled 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.
[FR Doc. E9-28747 Filed 11-27-09; 11:15 am]
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