Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies August 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-4188
• Issued by: Center for Tobacco Products

This final guidance is intended to help applicants (or “you”) design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report). TPPI studies are studies that 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. It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this final guidance. This final guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications: 

• Developing TPPI study aims and hypotheses 
• Designing quantitative and qualitative TPPI studies 
• Selecting and adapting measures of TPPI study constructs 
• Determining TPPI study outcomes
• Selecting and justifying TPPI study samples
• Analyzing TPPI study results

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