FDA Issues Guidance on Perception and Intention Studies

Source from:  Tobacco reporter 08/24/2022

The U.S. Food and Drug Administration Today issued a final guidance on guidance perception and intention studies.

The guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” 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, according to the FDA.

These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.

The final guidance addresses several 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

The guidance document is intended to provide clarity to applicants regarding existing requirements under the law, according to FDA.

“FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited,” the release states.