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PMTA or Bust

July 30, 2019

    The FDA clock counting down to the demise of the vast majority of the vaping industry has officially started ticking.

      As previously reported on this blog, a current court case brought against the FDA by the American Academy of Pediatrics and assorted others seems to be deciding the future for vapers.

      The FDA had previously set a deadline of 2021 for vape manufacturers to submit Premarket Tobacco Product Applications (PMTA's) in order to stay in business. This represented an extension from the original deadline set in 2017. A coalition of pediatricians and other public health related entities sued the FDA claiming that pushing the deadline back by four years was "so extreme as to amount to an abdication of [the FDA's] statutory responsibilities."

      Judge Paul W. Grimm sided with the pediatricians and has now set the deadline for PMTA's. The official due date is now May 11, 2020.

      "Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry's recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary," Grimm wrote in his order.

      This gives vape companies 10 months to submit what most in the industry see as impossibly expensive and voluminous documents that will effectively close down all but a handful of players in the vaping industry, pull 95% of vape products off the market and (surprise!) hand the industry to Big Tobacco since they may be the only ones able to afford the crushingly expensive application process.

      There is one remaining glimmer of hope. Contrary to early reports, the FDA does still have the option to appeal this ruling by filing a Notice of Appeal within 30 days. The FDA can also request a stay on the appropriately named Judge Grimm's decision which would basically put the ruling on ice while the appeal worked its way through the court system.

      But will the FDA appeal?

      SFATA's April Meyers

      I reached out to the President and CEO of Smoke Free Alternatives Trade Association (SFATA), April L. Meyers. She said that SFATA does not believe that the FDA will appeal. The reason for their belief is two fold. First, the FDA is under great political pressure on this issue and, second, the current acting Commissioner of the FDA, given that he is essentially a placeholder, will likely be reluctant to stick his neck out by intervening or appealing.

      Indeed, if you look at some of the statements by acting FDA Commissioner Ned Sharpless, the future looks pretty dismal for vapers.

      “Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth,” said Sharpless after the order was handed down.

      FDA's Acting Commissioner Ned Sharpless

      Sharpless seems to be following in the footsteps of his predecessor, Scott Gottlieb, by taking a bizarre and illogical anti-vaping stance. Take, for instance, the recent press release Sharpless put out entitled How FDA is Regulating E-Cigarettes. Sharpless began the press release with this baffling statement:

      "When I was Director of the National Cancer Institute (NCI), I would be frequently asked 'What topic in cancer research and cancer care keeps you up at night?' I always answered this question the same way: 'tobacco control in the era of e-cigarettes.'"

      Is Sharpless saying that e-cigarettes cause cancer? That e-cigarettes are somehow preventing people from quitting smoking? That vaping is the new menace to cancer researchers? As a director of the National Cancer Institute, surely Sharpless knows that while tobacco use causes cancer, nicotine itself is NOT designated as a carcinogen.

      "Does nicotine cause cancer? No." --- European Code Against Cancer, World Health Organization - International Agency for Research on Cancer

      World Health Organization

      "4 in 10 smokers and ex-smokers incorrectly think nicotine in cigarettes is the cause of most of the smoking-related cancer." --- Public Health England

      "The biggest misconception: Well over half of surveyed smokers believed that nicotine was the cancer-causing culprit in cigarettes. Nicotine does not cause cancer, but dozens of other chemicals found in tobacco products do." --- WebMD

      "One assessment of the published data on emissions from cigarettes and e-cigarettes calculated the lifetime cancer risks. It concluded that the cancer potencies of e-cigarettes were largely under 0.5% of the risk of smoking." --- Public Health England

      Public Health England

      "While it is biologically plausible that nicotine can act as a tumor promoter, the existing body of evidence indicates that this is unlikely to translate into increased risk of human cancer." -- 2018 report by the National Academies of Sciences, Engineering, and Medicine

      Given these facts, you would think, since e-cigarettes contain nicotine in isolation without all of the carcinogens present in cigarettes, that vaping would be enabling a director of the Cancer Institute to sleep more soundly. What gives?


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