February 1, 2010
Mr. Jonnie Williams
Chief Executive Officer
Star Scientific, Inc.
16 South Market Street
Petersburg, Virginia 23803
Dear Mr. Williams:
The Center for Tobacco Products (CTP) is aware that Star Scientific, Inc. is marketing two types of flavored, smokeless tobacco products that resemble candy products and dissolve in the mouth of the user. CTP appreciates your stated public commitment to prohibit youth access to tobacco products. We write to request information about the perception and use of these products by individuals, including those 25 years old and younger, and about consequences associated with their misuse.
According to your website, www.dissolvabletobacco.com, you market two dissolvable smokeless tobacco products to adult consumers—Ariva and Stonewall. Ariva is marketed as a “refreshing Wintergreen blend.” Stonewall is marketed as a “refreshing Wintergreen blend,” a “robust Natural tobacco blend,” and a “fresh brewed Java blend.” Both products come in small tablet form. According to your promotional materials, these products contain approximately 1.5 mg and 4.0 mg nicotine per unit, respectively.
Section 907(f) of the Federal Food, Drug, and Cosmetic Act requires the Tobacco Products Scientific Advisory Committee (TPSAC) to study “the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children” and provide us with a report and recommendations. CTP is concerned that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance and easily concealable size of many of these products. We are also concerned about the extent to which the high nicotine content and rapid dissolution of dissolvable tobacco products may facilitate initiation of tobacco use, nicotine dependence and addiction in adolescents, and may serve as a mechanism for inadvertent toxicity in children. The report and recommendations developed by the TPSAC should help CTP better understand these issues.
To help us support the work of the TPSAC, we request that you submit to CTP a comprehensive and detailed summary of your research activities and findings related to the topics below for both current products – Ariva and Stonewall – as well as any dissolvable products in development.
- Perceptions and Comprehension. Please provide CTP with a detailed summary of all information, including research conducted, supported, possessed or relied upon by your company, that relates to perceptions of dissolvable products by individuals under 26 years of age and the marketing of those products to such individuals. Research may include, but is not limited to, focus groups, surveys, experimental studies, taste panels, and assessments of the effectiveness of product marketing practices.
- Use of Product. Please provide CTP with a detailed summary of all information, including research conducted, supported, possessed or relied upon by your company, which relates to use of dissolvable tobacco products in users under 26 years of age. The summary should include demographics of users and patterns of use, including initiation of use in tobacco-naïve consumers by age.
- Misuse of Product. Please provide CTP with a detailed summary of all information, including research conducted, supported, possessed or relied upon by your company, that relates to the risk of accidental nicotine toxicity through use of dissolvable tobacco products, reports of accidental ingestion of dissolvable tobacco products, and the physiologic effects of swallowing or chewing the products, or otherwise not using the products as described in product labeling, advertising and promotional materials. Please also address any research on consumer understanding of the potential toxicity of these products to children.
To help us prepare this topic for the TPSAC in a timely manner, please submit your response to CTP no later than [2 months after date of the letter]. If you choose not to submit the requested information, please notify CTP of that decision no later than [30 days after date of the letter]. The submission should be prominently identified with the label “FDA 01-2010 Dissolvables Request” and sent to the following address:
Center for Tobacco Products
Food and Drug Administration
Attn: Document Control Center
9200 Corporate Boulevard
Rockville, Maryland 20850
We encourage you to submit your response in an electronic format on CD-ROM or DVD. Please see the attached document for guidance in preparing your electronic submission to CTP.
We look forward to your prompt response and to working with you and other stakeholders on issues regarding access to these products by adolescents and children, and risks associated with their accidental or improper use.
Lawrence Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products
Food and Drug Administration
Electronic Submission Instructions
We request that you to submit your response in text-searchable PDF file(s) on a CD-ROM or DVD. The files should include a signed cover letter prominently identified as “FDA 01-2010 Dissolvables Request,” and should also identify the software (name, version, and company) that you used to confirm the submission is free of viruses or other malware.
The CD-ROM or DVD media should be labeled with your company name, contact phone number, “FDA 01-2010 Dissolvables Request,” submission date, and series number (e.g., “disc 1 of 2”).
If you plan to submit PDF files, they should not contain any attached, embedded or bundled files. If your summary or any supplementary documents are scanned, you should verify the accuracy of optical character recognition and legibility of the document. To improve the organization and readability of the electronic documents we request that you include a well-structured table of contents and use bookmarks and hypertext links.
We suggest that the first level of detail in your table of contents be the numbered items in this information request. The second level of detail should describe the contents of each item (e.g., general summary, study description, study results).
In general, bookmarks should be provided for each item listed in the table of contents including all major section headings and subheadings. All tables, figures, publications, references, and appendices should also be bookmarked. Hypertext links should be used to connect text to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page as the text. Hypertext links should be designated by blue text.