On March 1, the Tobacco Products Scientific Advisory Committee (TPSAC) submitted their final report and recommendations to FDA on the evaluation of the available scientific evidence on the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.
TPSAC’s report and recommendations on dissolvable tobacco products addresses:
- 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
- the increased or decreased likelihood that those who don’t currently use tobacco products will start using such products.
FDA will consider the report and recommendations and continue to review all of the available science concerning dissolvable tobacco products. FDA will then determine what future action(s), if any, are warranted. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not set a required deadline or timeline for FDA to act on these recommendations.
FDA will also continue conducting research on dissolvable tobacco products, provide ongoing monitoring of adverse events related to these products to protect public health, and take any regulatory actions necessary under its authority, which includes reviewing new product applications and substantial equivalence reports.
TPSAC is a panel of leading public health, scientific experts and representatives of various parts of the tobacco industry, charged with providing advice, information, and recommendations to FDA on health issues related to tobacco products and other issues relating to the regulation of tobacco products.
The Tobacco Control Act requires TPSAC to deliver its final report and recommendations to FDA on behalf of the Secretary of Health and Human Services (HHS) by March 23, 2012.
The final report and recommendations will also be made available to the public on the FDA’s Center for Tobacco Products website, once it has been reviewed and all commercial confidential or trade secret information has been redacted.