The FDA has added new guidance to the PMTA process on how to conduct a study on product intention that is to be submitted with applications.

FDA Changes PMTA Application Process Again



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FDA

The FDA has added new guidance to the PMTA process on how to conduct a study on Tobacco Product Perception and Intention (TPPI) that "may be" submitted along with applications to gain approval for market.

The PMTA deadline has already passed (Sept. 9 2020), after being extended by several months due to the pandemic. 

Many small vape companies had already decided to close their business, laying off employees in the face of the already expensive and burdensome approval process. Adding more study requirements, even in the form of guidance, after the application deadline has passed seems very strange. 

From the FDA.gov guidance document -- Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies:

This draft guidance is intended to help applicants (or “you”) design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a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use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance. This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications: 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

FDA.gov

The @FDATobacco twitter account had a small thread on the guidance document:

Today, FDA issued a draft guidance that describes the agency’s recommendations on designing and conducting tobacco product perception and intention (TPPI) studies that may be submitted as part of a tobacco product application.

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.

The draft guidance provides, among other things, an overview of general scientific principles to consider regarding TPPI study design and methods, selection and justification of study samples, data collection, and analysis and reporting of study results.

With this draft guidance, FDA aims to help applicants prepare TPPI studies that can help demonstrate that a tobacco product meets the applicable marketing authorization standard.

Starting tomorrow, Oct. 28, public comments related to this draft guidance may be submitted through Dec. 28, 2020.

@FDATobacco on Twitter

Public comments on this guidance are accepted at the Federal Register.

Why add this guidance now?


From the proposed guidance document

This guidance communicates FDA’s current thinking on these applications to improve the efficiency of application submission and review; however, the recommendations in this guidance are non-binding. When FDA reviews PMTAs for ENDS, it will base decisions on the obligations that arise from the FD&C Act and its implementing regulations.
FDA guidance document on Tobacco Products

Reading between the lines, it seems that these studies aren't required but "encouraged".

As we are not regulatory compliance lawyers, it is unclear whether the companies may want to conduct these studies on each product application which would just add to the already crippling costs and lengthy approval process. 

One potential upside would be the products submitted by vape companies may be able to remain on the market for a more extended period of time, assuming most applications are going to be denied for of filling out the forms incorrectly. 

During our research for this article, we were unable to find a reference to the exact phrase, "tobacco product perception and intention" or TPPI, in a tobacco related context, before this new guidance was released. 

We did find this sort of terminology in a proposed rule, a pre-written regulation, that was drafted by Stanton Glantz and friends over at the UCSF Center for Tobacco Control and Research in late 2019.