August 23, 2022
On August 23, FDA issued a final guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.”
This guidance is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report). TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products. These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.
This final guidance addresses the following scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:
- Developing study aims and hypotheses
- Designing quantitative and qualitative studies
- Selecting and adapting measures of study constructs
- Determining study outcomes
- Selecting and justifying study samples
- Analyzing study results
This guidance document is intended to provide clarity to applicants regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited.