SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued new draft guidance on how to submit tobacco product perception and intention studies that may be submitted as part of a tobacco product application.
That application could be a modified risk tobacco product (MRTP) application, premarket tobacco product application (PMTA) or substantial equivalence (SE) report.
Tobacco product perception and intention studies are used to assess individuals’ perceptions of tobacco products, understanding of tobacco product information and intentions to use tobacco products, the FDA said. Its draft guidance provides an overview of general scientific principles to consider regarding the studies’ design and methods. While not legally binding, it is intended to help applicants prepare studies that can help demonstrate a tobacco product meets the applicable marketing authorization standard, the FDA said.
The administration is accepting public comments related to the draft guidance through Dec. 28.
The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time. To market new products that have come out since then, manufactures must submit one of the following three: A PMTA, SE report or a Request for Exemption from Demonstrating Substantial Equivalence.