Q and As: Tobacco Products and Scientific Advisory Committee’s Report and Recommendations on Dissolvable Tobacco Products and the Nature and Impact on Public Health, Including Such Use Among Children
Throughout this document FDA uses the following terms:
- The Committee – refers to the Tobacco Products Scientific Advisory Committee
- Report – refers to the TPSAC report and recommendations on dissolvable tobacco products and the nature and impact on public health, including such use among children required by the Family Smoking Prevention and Tobacco Control Act (TCA)
- The Secretary – refers to the Secretary of Health and Human Services
- The Agency – refers to the U.S. Food and Drug Administration
Why was the Committee charged with developing and submitting a report and recommendations to the Secretary on the nature and impact of dissolvable tobacco products on the public health, including such use among children?
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the Tobacco Products Scientific Advisory Committee (TPSAC) to submit a report and recommendations to the Secretary of Health and Human Services (HHS) on the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The report and recommendations are due to the Secretary by March 23, 2012. The report is considered submitted to the Secretary once received by the U.S. Food and Drug Administration (FDA).
What do the TPSAC report and recommendations address?
The report addresses the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children by considering the scientific data on:
- the risks and benefits of dissolvable tobacco products to the population as a whole, including users and nonusers of tobacco products;
- the increased or decreased likelihood that current tobacco users will stop using such products; and
- the increased or decreased likelihood that those who don’t currently use tobacco products will start using such products.
What will the FDA do with the report and when will FDA act on the recommendations provided by the TPSAC in the report?
The FDA will consider the report and recommendations of the Committee, and continue to review all of the available science concerning dissolvable tobacco products. The FDA will then make a determination about what future action(s), if any, are warranted.
The Tobacco Control Act does not set a required deadline or timeline for the FDA to act on the recommendations provided by the Committee in the report.
How will the TPSAC report and recommendations be structured?
TPSAC’s report on dissolvable tobacco products consists of all the materials from the Committee meetings on this topic. This includes a summary and recommendations from the Committee as well as background materials, published literature, transcripts, presentations, public submissions, and minutes from all TPSAC meetings on dissolvable tobacco products The report is considered submitted to the Secretary of HHS once received by the FDA (as the delegated authority for the Secretary). The final report and recommendations will also be made available to the public on the FDA’s Center for Tobacco Products website once they have been reviewed and all commercial confidential or trade secret information has been redacted.
What information was used by the Committee to develop the report and recommendations?
TPSAC reviewed and considered multiple sources of evidence for the report and recommendations on the impact of the use of dissolvable tobacco products on the public health, including such use among children. Sources of evidence that were reviewed and considered included peer-reviewed literature, additional data and information commissioned by the FDA at the request of the TPSAC, tobacco company submissions, and public comments from a wide range of stakeholders.
Were industry representatives allowed to participate in the development of the Report?
The industry representatives participated in the development of the report and recommendations by means of their participation in the TPSAC meeting discussions.
The industry representatives had many opportunities to contribute to the development of the report, including:
- Participating in open discussions and deliberation on the non-confidential/trade secret evidence that the TPSAC relied on in the report
- Participating in open discussions and deliberation on how the report should be organized
- Participating in discussions regarding the development of the Committee recommendations included in the final summary and report
Will the final TPSAC report on dissolvable tobacco products be made available to the public?
The final report and recommendations will be made available to the public on the FDA’s Center for Tobacco Products website once they have been reviewed and all commercial confidential or trade secret information has been redacted.
How are TPSAC members screened for conflict of interest?
At the time of appointment, the agency conducted a careful conflict of interest screening process for all TPSAC members who are Special Government Employees (SGE) and Regular Government Employees (RGE). Each SGE and RGE was found to satisfy the conflict of interest provision of the Tobacco Control Act, as well as federal ethics and conflict of interest laws including, but not limited to, those found at 18 U.S.C. Section 208 and Section 712 of the Federal Food, Drug, and Cosmetic Act. In accordance with federal statutes, regulations, and FDA procedures, FDA screened for conflict of interest before every meeting, and will continue to screen committee members for potential conflicts of interest arising from particular matters to be considered by the TPSAC.