Tobacco Regulatory Science Program | ODP

The Tobacco Regulatory Science Program (TRSP) is an interagency partnership between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Center for Tobacco Products to foster tobacco regulatory research.

With funds from the FDA, NIH can provide new funding opportunities in tobacco regulatory science that complement existing NIH tobacco research activities.

Funding

Funding Opportunities

  • RFA-OD-25-008 : Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional). FAQs about the opportunity are now available.

Notices

  • NOT-OD-24-172 : Notice of Early Expiration of the Tobacco Regulatory Science K Notice of Funding Opportunity Announcements
  • NOT-OD-25-001 : Notice of Early Expiration of RFA-OD-23-017 "Tobacco Regulatory Science (R01 Clinical Trial Optional)"

News

FDA Proposes Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Tobacco Products

On January 15, 2025, FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today. Based on the scientific evidence outlined in the proposed rule, the proposed nicotine level would be low enough to no longer create or sustain addiction. Importantly, a large body of research also shows reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more. The agency intends to seek input on the proposal, including through a public comment period that will be open January 16 through September 15, 2025.

About TRSP
An NIH-FDA partnership to foster tobacco regulatory research.
About TRSP
Tobacco Centers of Regulatory Science
Made up of scientists with a broad range of expertise, they generate critical research that informs the FDA's regulation of tobacco products.
Tobacco Centers of Regulatory Science
TRSP Research Priorities
Research topic and project priorities for TRSP funding opportunities.
TRSP Research Priorities

Using Investigational Tobacco Products

This guidance will assist investigators who are seeking to request Investigational Tobacco Products (ITP) authorization or information to determine whether an ITP is needed when administering tobacco products to human study participants.

Read the Guidance (PDF)