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

Docket Number:
Issued by:
Guidance Issuing Office
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

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-4188.


Contact Point
Contact CTP
Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
Twitter: https://twitter.com/FDATobacco
FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco
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