FDA Sets Final Guidelines for Tobacco Studies

Agency also updates 'grandfathered tobacco product’ term
FDA sign
Photograph: Shutterstock

SILVER SPRING, Md. —The U.S. Food and Drug Administration (FDA) has issued its final guidance on tobacco product perception and intention studies.

This guidance is intended to help applicants complete 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 (SE) report.

The TPPI studies can be used to assess individuals’ perceptions of tobacco products, understanding of tobacco product 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,” the FDA said.

In other tobacco news, the FDA in August updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to better define these products.

“Additionally, the term ‘grandfathered’—when used to describe someone or something exempt from a new law or regulation—has its roots in 19th century racist voting laws. Therefore, this terminology has been updated in accordance with [Center for Tobacco Products’] commitment to diversity, equity, inclusion and accessibility,” the FDA said.

A pre-existing tobacco product is any tobacco product, including those in test markets, that was commercially marketed in the United States as of Feb. 15, 2007.

Visit the FDA’s website for more information on the TPPI guidance.

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