The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by the President in June 2009, created the FDA Center for Tobacco Products and granted it authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Under the law, FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. The law also gave FDA the ability to regulate additional tobacco products, commonly referred to as “deeming” them through rulemaking.
FDA finalized the “deeming” rule, effective August 8, 2016 “to regulate all tobacco products that were not under its jurisdiction that meets the statutory definition of “tobacco product”, including Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products, but not including accessories of newly deemed products.” Products deemed under this rule are subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, including but not limited to: (1) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (2) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use; and (3) premarket review requirements. These actions will improve the public health by affording FDA information regarding the health risks of such products, evaluating whether marketing of new products would be appropriate for the protection of public health or are substantially equivalent to an identified predicate product, and preventing misleading claims about the relative risk of tobacco products. In addition, FDA has the authority to develop product standards, when appropriate for the protection of public health.
Applications are due July 17, 2020.