Document ID: FDA-2010-N-0123-0001
Agency: fda
Document Type: Notice
Title: Impact of Dissolvable Tobacco Use on Public Health; Request for Comments
Posted Date: 2010-03-22T04:00Z

[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]               
[Page 13556-13557]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr10-68]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0123]

 
Impact of Dissolvable Tobacco Use on Public Health; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to provide an opportunity for interested parties to share 
information, research, and ideas on how use of dissolvable tobacco 
products may impact public health, including such use among children. 
This information will be used to support the work of the Tobacco 
Products Scientific Advisory Committee, which is charged with 
evaluating this issue.

DATES: Submit written or electronic comments by [insert date 180 days 
from date of publication in the Federal Register].

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.

FOR FURTHER INFORMATION CONTACT: Kathleen K. Quinn, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, Kathleen.Quinn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Tobacco products are responsible for more than 440,000 deaths each 
year. The Centers for Disease Control and Prevention report that every 
day in the United States, approximately 3,900 young people between 
these ages of 12 and 17 smoke their first cigarette and approximately 
1,000 adolescents become daily smokers. Multiple studies have shown 
that adolescents who use smokeless tobacco products are more likely to 
become smokers than those who do not.
    Dissolvable tobacco products are a novel class of smokeless tobacco 
products, which are sold as thin strips, tablets, and sticks resembling 
toothpicks. Because some of these products look like candy, are highly 
flavored, and can be easily concealed, public health officials have 
raised concerns that dissolvable tobacco products may be particularly 
appealing to children and adolescents. These products also contain up 
to 4.0 milligrams of nicotine per unit, which could facilitate 
initiation of tobacco use and the development of nicotine dependence in 
adolescents, or even serve as a mechanism for inadvertent toxicity in 
children.
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) into law. 
The Tobacco Control Act granted 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. Among its many provisions, the Tobacco Control Act added 
section 907(f) to the Federal Food, Drug, and Cosmetic Act (the act). 
This section requires FDA to refer the issue of ``the nature and impact 
of the use of dissolvable tobacco products on the public health, 
including such use among children'' to a Tobacco Products Scientific 
Advisory Committee, which will be charged with providing FDA a report 
and recommendations.
    We are requesting comments that will support the work of the 
Tobacco Products Scientific Advisory Committee in evaluating the public 
health impact of dissolvable tobacco products. A copy of the Tobacco 
Control Act is available at http://www.fda.gov/tobacco.

II. Request for Comments and Information

    Data around the nature, impact, and use of dissolvables tobacco 
products will be critical to the Tobacco Products Scientific Advisory 
Committee in studying and reporting on their public health impact. We 
are therefore requesting comment, research, and data on ways in which 
these products might be used by individuals, including children and 
adolescents, how the risks of using these products are perceived by 
smokers and non-smokers, and how use of these products affects health. 
Such research may address:

[[Page 13557]]

     Perceptions of dissolvable tobacco products from current 
tobacco users and tobacco-na[iuml]ve individuals, by age;
     Marketing of dissolvable tobacco products to current 
tobacco users and tobacco-na[iuml]ve individuals, by age;
     Impact of dissolvable tobacco products on initiation of 
tobacco use in tobacco-na[iuml]ve individuals, by age;
     Dual use of dissolvable tobacco products by current 
tobacco users;
     Impact of dissolvable tobacco products on cessation of 
tobacco use;
     Risk of accidental ingestion of dissolvable tobacco 
products;
     Risk of accidental nicotine toxicity through use of 
dissolvable tobacco products; and
     Consumer understanding of the potential toxicity of 
dissolvable tobacco products to children.

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 by 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.

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6216 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S