According to a report by Filter, the United States Food and Drug Administration (FDA) may authorize electronic cigarette flavors other than tobacco and menthol in the future.
New documents reveal that the FDA's relationship with big tobacco companies is not ordinary, as the FDA seems to favor big tobacco companies over small businesses.
Documents obtained by Filter earlier this year clearly indicate bias by FDA towards flavored electronic cigarette products. While PMTA applications from small and medium-sized businesses were rejected, PMTA reviewers created a process to swiftly reject many of these companies' tobacco products without reviewing their submitted files, allowing for the backlog of millions of PMTAs to be addressed.
Another article from Filter explains that this method is called the "deadly flaw" strategy, which involves "database queries to identify the top twelve manufacturers in the unscientifically reviewed non-tobacco flavored e-cigarette products by pending count," and determine if any of them include randomized controlled trials (RCTs) or longitudinal cohort studies.
Although the FDA may plan to authorize flavors, new documents discussed by Filter indicate that the FDA's relationship with large tobacco companies and its tendency to favor big corporations over small businesses are also factors to consider.
According to a report by Filter, while the overall plan is consistent with the FDA's extensive information, the focus of its PMTA review process will be on the companies with the largest market share, revealing how ridiculous this priority has become.
The guiding principles for the PMTA application process are as follows:
1. Simplicity: The chosen method should be easy to manage, explain, and implement.
Defensible: The decision was not arbitrary or capricious.
3. Flexibility: If necessary, the process provides an opportunity to adjust strategies easily.
4. Supporting public health goals: Minimize youth initiation as much as possible; ensure that various nicotine electronic cigarettes (delivery systems) ENDs have the opportunity to remain on the market to help adult smokers switch to less harmful tobacco products.
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