2010-6216. 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, [e-mail].

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:

• Perceptions of dissolvable tobacco products from current tobacco users and tobacco-naïve individuals, by age;
• Marketing of dissolvable tobacco products to current tobacco users and tobacco-naïve individuals, by age;
• Impact of dissolvable tobacco products on initiation of tobacco use in tobacco-naïve 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.