
[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Proposed Rules]
[Page 6056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01626]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1142

[Docket No. FDA-2012-N-1032]


Smokeless Tobacco Product Warning Statements; Request for 
Comments and Scientific Evidence

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to obtain comments, supported by scientific evidence, 
regarding what changes to the smokeless tobacco product warnings, if 
any, would promote greater public understanding of the risks associated 
with the use of smokeless tobacco products.

DATES: Submit electronic or written comments by April 1, 2013.

ADDRESSES: Submit electronic comments 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, 1-877-287-
1373, gail.schmerfeld@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) 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 
Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco 
Act) (15 U.S.C. 4402) to prescribe new requirements for health warnings 
that must appear on smokeless tobacco product packages and advertising. 
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(1) and (b)(1)), requires 
that smokeless tobacco product packages and advertising must bear one 
of four required warning statements. The four required warning 
statements are:
    ``WARNING: This product can cause mouth cancer.''
    ``WARNING: This product can cause gum disease and tooth loss.''
    ``WARNING: This product is not a safe alternative to cigarettes.''
    ``WARNING: Smokeless tobacco is addictive.'' (15 U.S.C. 4402(a)(1))
    One of the four required warning statements must be located on each 
of the two principal display panels of the package and comprise at 
least 30 percent of each such display panel (15 U.S.C. 4402(a)(2)(A)). 
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(2) and (b)(2)), also sets 
forth requirements for the placement, type, size, and color of warnings 
on packaging and advertisements, respectively.
    Section 205(a) of the Tobacco Control Act further amended section 3 
of the Smokeless Tobacco Act to give FDA the authority to ``adjust the 
format, type size and text of any of the label requirements, require 
color graphics to accompany the text, increase the required label area 
from 30 up to 50 percent of the front and rear panels of the package, 
or establish the format, type size, and text of any other disclosures 
required under the Federal Food, Drug, and Cosmetic Act'' through 
rulemaking conducted under the Administrative Procedures Act (5 U.S.C. 
552, et seq.) if FDA ``finds that such a change would promote greater 
public understanding of the risks associated with the use of smokeless 
tobacco products'' (15 U.S.C. 4402(d)).

II. Request for Scientific Evidence and Information

    We are interested in comments, supported by scientific evidence, 
regarding what changes, if any, to the smokeless tobacco product 
warnings would promote greater public understanding of the risks 
associated with the use of smokeless tobacco products. The ``public'' 
includes both tobacco users and nonusers (i.e., never users and former 
users). Comments and supporting evidence should address how any changes 
in the warnings would affect both users' and nonusers' understanding of 
the risks associated with the use of smokeless tobacco products.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01626 Filed 1-28-13; 8:45 am]
BILLING CODE 4160-01-P


