FDA pushes back date for finishing PMTAs (again)

The convenience store trade publication CSP reported that the FDA has pushed the anticipated date for finishing making decisions on premarket tobacco product applications (PMTAs) — mostly e-cigarettes — again, this time to the end of 2023.

According to CSP,

The Food and Drug Administration is going to need until the end of 2023 to review covered applications under the premarket tobacco product application (PMTA) process. Previously, the agency said it would be done by June, but challenges in court from e-cigarette suppliers Juul, Logic, Njoy and Fontem are delaying the process, the FDA said. … “Defending those lawsuits and undertaking multiple related application re-reviews continues to require substantial agency resources,” the FDA said in its filing, a copy of which was provided by the National Association of Tobacco Outlets (NATO). “The FDA’s revised projections also reflect the fact that, for some pending covered applications, the agency has received amendments that it has accepted and is considering.”

In response to lawsuits from health groups, the court put a deadline of September 9, 2021 on completing the review process.

And I doubt that the FDA will even finish by the end of 2023. They reported to the court that they expect to finish 52% of applications by March 31, 1% more (53%) by June 30, another 2% (55%) by September 30, then a whopping 45% (to 100%) by December 31.

Of course, it is not the FDA’s fault that the e-cig companies are suing them (although defending themselves would be easier if they accepted the reality that e-cigarettes as consumer products don’t help smokers quit), but the reality is that the e-cig companies are out there promoting and selling their products as the clock keeps ticking.

In the meantime, FDA should deny the remaining PMTA applications for menthol e-cigs. The companies will like sue over that, too, but at least it will start the clock ticking.

More important, the continuing failure of the FDA to successfully take meaningful action to protect the public — especially kids — from e-cigarettes reinforces the importance of local action to address the e-cigarette epidemic: bans on sales of all flavored tobacco products, including e-cigarettes in clean indoor air laws, and taxing e-cigarettes comparably to other tobacco products.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

3 thoughts on “FDA pushes back date for finishing PMTAs (again)

  1. Vaping as consumer products do help people quit. I smoked for over 30 years and none of the approved replacement therapies worked for me. Vaping did. I did however once try an “e cigarette” a decade ago but they were ineffective. Nobody uses those cig alikes anymore. Also, referring to vapes as “tobacco products” just confuses everyone. My vape set up has no tobacco and neither the hardware I use or the liquids used have any connection with the tobacco industry. Time for some honesty if you really are vested in reducing the harm caused by smoking.


    1. There is no question that vaping has helped some people quit smoking. There is also no question that vaping has made it harder for other people to quit smoking. So, the overall population effect — what FDA has to consider in deciding whether authorizing the sale of a specific e-cigarette is “appropriate for the protection of public health” — is that there is no cessation benefit for the population as a whole.

      Absent a real cessation benefit, whether or not the specific toxicity of e-cigarettes are lower, higher or the same as cigarettes is not even a relevant question.

      And, of course, there is no population health benefit for he millions of kids and former smokers e-cigarettes attract back to nicotine addiction.

      On the second point: Most vapes are “made or derived from tobacco” and Congress closed the loophole for the few that use synthetic nicotine last year.


      1. Here’s the Convenience Store News category:

        Convenience store tobacco smoking and vaping products including cigarettes, cigars, electronic cigarettes and cigars, smokeless RYO Tobacco and accessories.

        There’s no confusion. They know what they’re selling.

        These are all products made or derived from tobacco, designed to create and maintain nicotine addiction, and sold to a population that’s increasingly dual and multi using them as different tobacco products:


        Your local c-store is perfectly clear on what they’re selling and why it sells. There’s no reason anyone else should be confused.


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