New documents reveal that despite that not having done so yet, the US Food and Drug Administration (FDA) may in the future be authorizing vape flavours other than tobacco and menthol.
Documents obtained by Filter earlier this year, had clearly indicated a bias towards flavoured vape products. While PMTAs for small to medium-sized businesses were being rejected by the thousands, these documents revealed that PMTA reviewers had created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without even reviewing their submitted documents.
Called the “Fatal Flaw” strategy, the method would involve a “a database query to identify the top twelve manufacturers with the largest number of pending” PMTAs for non-tobacco flavoured e-liquid products not in scientific review—and determine if any of them contained randomized control trials (RCTs) or longitudinal cohort studies,” explained another recent article.
The FDA’s ties to Big Tobacco
Meanwhile despite possible plans to authorize flavours, the new documents discussed by Filter also indicate the agency’s ties to Big Tobacco and its tendency to favor the largest companies, instead of the smaller businesses.
“Though the general plan remains consistent with the FDA’s broad messaging—that its PMTA review process would focus on the companies with the largest market share—it reveals how rigid that prioritization became,” reported Filter.
“‘As the application submission deadline approaches, OS anticipates a significant increase in the number of premarket applications for all three premarket pathways,” the plan reads. “In preparation for the increase … OS determined that updates to the review process are necessary to ensure that we can efficiently initiate and complete review of as many applications as possible during the one-year compliance period while applying the same scientific rigor.’
The PMTA’s process guiding principles
The memo includes a list of “guiding principles”:
·Simple: Selected approach should be easy to manage, explain, & implement
·Defendable: Decisions are not arbitrary & capricious
·Flexible: Process offers the opportunity to easily pivot and adjust the strategy, if needed
·Supports our public health goals: 1. Minimize youth initiation 2. Ensure a variety of ENDS have an opportunity to remain on the market to facilitate adult smokers switching to less harmful tobacco products”