February 20, 2019
“At the very time that we’re seeking to render combustible cigarettes minimally or nonaddictive, it’s critical we continue to build our understanding of the public health impacts of all tobacco products – including new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the additional risks associated with lighting tobacco on fire. As part of that work, we’re providing revised draft guidance for researchers and manufacturers studying new or novel tobacco products for general knowledge or to support premarket applications or other product submissions. Research on investigational tobacco products can help the FDA determine whether new tobacco products meet the agency’s regulatory public health standards and expand our knowledge base to inform our regulatory efforts to protect the public health,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to the effective and appropriate regulatory oversight of tobacco products as part of our comprehensive efforts to protect kids and significantly reduce tobacco-related disease and death. This includes developing new guidance and regulations that will better spell out the rules of the road for industry and taking steps to improve efficiency, predictability and transparency of our regulatory work.”
Today, the U.S. Food and Drug Administration issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products. Among other things, it outlines the kind of information the agency intends to consider in making enforcement decisions regarding the use of investigational tobacco products, including potential human subject protection concerns or other impacts on public health. This revised draft guidance is part of the agency’s work on its comprehensive plan for tobacco and nicotine regulation, in which the FDA committed to developing new guidance and regulations to make the science-based regulatory review process more efficient and transparent while upholding the agency’s public health mission.
Researchers and manufacturers may choose to sponsor studies of investigational tobacco products to support premarket applications or other submissions such as modified risk tobacco product applications. Researchers and manufacturers may also seek to study investigational tobacco products for general knowledge. For example, a researcher may study tobacco products with special characteristics (such as low nicotine content, or reduced harmful and potentially harmful constituent delivery) and/or evaluate their use in a particular situation (like their impact on specific populations).
After receiving numerous comments on the September 2015 draft guidance, the FDA is issuing this revised draft guidance to make a number of clarifications. For example, the agency has clarified that it is not proposing to recommend that investigators correspond with the FDA about the use of investigational tobacco products in nonclinical studies. However, sponsors of nonclinical studies may elect to meet with the FDA early in the development process to discuss what, if any, animal testing is appropriate and the suitability and acceptability of non-animal tests for a particular tobacco product. The agency also has modified the proposed form for sponsors who would like the FDA’s feedback on a particular proposed use of an investigational tobacco product to make it clearer and more user-friendly.
- Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death
- Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
- FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.