On October 27, FDA issued a new draft guidance, entitled “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.” The draft guidance describes the FDA Center for Tobacco Products’ proposed recommendations on designing and conducting tobacco product perception and intention studies (TPPI). Such studies may be submitted as part of FDA tobacco product applications, including modified risk tobacco product (MRTP) applications, premarket tobacco applications (PMTA) and substantial equivalence (SE) reports.
TPPI studies are studies that can address consumers’ perceptions of tobacco products, intentions to use tobacco products and understanding of product labeling. The draft guidance provides an overview of principles to consider regarding the design of TPPI studies, including identifying appropriate study outcomes, selecting study samples and reporting study results.
Although the draft guidance does not identify the circumstances under which TPPI studies might be required or warranted in connection with tobacco product applications, the guidance does provide examples of potential TPPI study outcomes, such as addressing whether product quantity changes may have an impact on consumer use, showing whether the introduction of the tobacco product will be appealing to non-users or cause existing users to switch to less-hazardous alternatives, and addressing the extent to which consumers comprehend product labeling and instructions.
While not legally binding, the draft guidance reflects the agency’s recommendations for TPPI studies that can support MRTPAs, PMTAs or SE reports. Notably, however, the TPPI draft guidance was issued several weeks after the September 9 deadline for requests for marketing authorization for deemed tobacco products. And industry continues to await FDA’s finalization of proposed rules for PMTAs and SE reports.
The draft guidance is open for public comment, which comments may be submitted through December 28, 2020.