Tobacco Regulatory Research Tools & Resources

What's New

Recent critical health events, such as e-cigarette or vaping product use-associated lung injury and the COVID-19 pandemic, highlight the importance of examining how tobacco and nicotine products may influence and interact with respiratory healthThis special issue from the journal of Nicotine & Tobacco Research on respiratory disease associations with cigarettes and noncigarette nicotine and tobacco use includes a collection of multidisciplinary studies that begin to examine the effect of tobacco and nicotine use from the cellular level to patterns of use and symptomology at the population level.

Resources for Researchers

Explore databases and tools for research to support the regulation of tobacco and tobacco products.

PhenX Toolkit: Tobacco Regulatory Research (TRR) Collections

A catalog of recommended standard measures of phenotypes and environmental exposures for use in biomedical research. This includes common data elements for tobacco regulatory research.

Learn more about the PhenX Tobacco Regulatory Project and how these measures were identified, selected, and approved

NIDA Nicotine Research Cigarettes Drug Supply Program

Provides a variety of research chemicals, controlled substances, marijuana cigarettes, and nicotine research cigarettes to investigators working in the area of drug abuse, addiction, and related disciplines. 

Regulatory Research Project Search Tool

Access to information about active research projects in the FDA Center for Tobacco Products research portfolio.

Tobacco Control Monograph Series

Ongoing and timely information about emerging public health issues in smoking and tobacco use control from the National Cancer Institute.

Regulatory Research Information

Using Investigational Tobacco Products (PDF)

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.

Clinical Studies Involving Electronic Cigarettes and INDs – FAQs

Answers to common questions about clinical studies of e-cigarettes examining a potential therapeutic purpose (e.g., smoking cessation), which may require an investigational new drug application. Such studies are not funded through TRSP.

Informing Tobacco Regulation Through Research

Addresses the importance of tobacco research, research advances, funding opportunities, and ways to use the research.

Tobacco Researcher Interviews

Video interviews with leading researchers in tobacco regulatory research who share their work and discuss its importance to public health.

Tobacco Regulatory Science: Research To Inform Regulatory Action at the Food and Drug Administration’s Center for Tobacco Products

Clarifies the definition and role of regulatory science and describes the types of research efforts that will inform the FDA’s public health framework for tobacco product regulation.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants

This document provides points to consider regarding applications from grantees that also receive support from the tobacco industry or their related entities. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted in response to TRSP funding opportunity announcements.

 

Last updated on June 10, 2021