[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56842-56843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26466]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Listing of Ingredients in Tobacco 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availability of a draft guidance for industry entitled ``Listing of 
Ingredients in Tobacco Products.'' The draft guidance document is 
intended to assist persons making tobacco product ingredient 
submissions to FDA as required by section 904 of the Federal Food, 
Drug, and Cosmetic Act (the act) as added by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by November 13, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Listing of Ingredients in Tobacco 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your request or include a fax number to which the draft guidance 
document may be sent.
    Submit electronic comments to http://www.regulations.gov. 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. Identify comments with the docket number found in 
brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance 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:

I. Background

    On June 22, 2009, the President signed the Tobacco Control act 
(Public Law 111-31) into law. The Tobacco Control Act amended the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) 
by, among other things, adding a new chapter granting FDA important new 
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 904(a)(1) of the act, as amended by the Tobacco Control 
Act, requires each tobacco product manufacturer or importer, or agent 
thereof, 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.'' 
Since the Tobacco Control act was enacted on June 22, 2009, the 
information required under section 904(a)(1) must be submitted to FDA 
by December 22, 2009, and include the ingredients added as of the date 
of submission. While electronic submission of ingredient listing 
information is not required, FDA is strongly encouraging electronic 
submission to facilitate efficiency and timeliness of data management 
and collection. To that end, FDA designed the eSubmitter application to 
streamline the data entry process for ingredient listing. This tool 
allows for importation of large quantities of structured data, 
attachments of files (e.g., in portable document format (PDFs) and 
certain media files), and automatic acknowledgement of FDA's receipt of 
submissions.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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. The guidance

[[Page 56843]]

document and 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 draft guidance contains proposed collections of information 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
As required by the PRA, FDA has published an analysis of the 
information collection concerning the submission of ingredient 
information (74 FR 45219, September 1, 2009, as corrected by 74 FR 
47257, September 15, 2009) and will submit it for OMB approval.

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: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26466 Filed 10-30-09; 11:15 am]
BILLING CODE 4160-01-S