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Tobacco Science & Research

FDA supports science and research to help us better understand tobacco use and associated risks so that we can reduce the public health burden of tobacco in the United States. 

Research programs and projects include, but are not limited to, the scientific fields of epidemiology, behavior, biology, medicine, economics, chemistry, engineering, toxicology, pharmacology, addiction, public health, communications, marketing, and statistics. 

Research News

Stay current on FDA's tobacco regulatory science and research efforts, tobacco scientific publications and study findings, and research grants by subscribing to CTP's quarterly Spotlight on Science newsletter.

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Studies Involving Administration of Unauthorized Tobacco Products

If you plan to study tobacco products that do not have marketing authorization or that do not comply with an applicable tobacco product standard, you may submit your proposed protocol to FDA for review. FDA intends to evaluate specific uses of investigational tobacco products on a case-by-case basis according to potential human subject protection concerns or other impacts on public health.

Generally, FDA does not recommend that investigators correspond with us about the use of investigational tobacco products in nonclinical studies as these are not ordinarily reviewed. You may refer to the draft guidance ‘Use of Investigational Tobacco Products’ for more information regarding how to submit your proposed use of an investigational tobacco product and how FDA intends to make enforcement decisions regarding the use of investigational tobacco products.

FDA understands that investigators may choose to obtain tobacco products directly from a tobacco product manufacturer with the sole intent to use the products for research investigations without commercializing the products. In such cases, FDA recommends that investigators add language to all product labels to indicate that these products are limited to investigational use, that study participants be instructed that the products may not be further distributed, and that study protocols include a plan to collect and account for all investigational tobacco products after the study has concluded.

Ongoing Research


Additional Resources