PMTA or Bust

July 30, 2019 3 Comments

    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 uselessly bureaucratic 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 will 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,” chirped 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 "Epidemic" 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 promotor, 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?

      Sleep

      The more I try to break down Sharpless's statement, the less I can understand what he could possibly be saying other than to incorrectly link vaping to cancer in the minds of the public. To try to untangle the intent behind his statement, let's read a bit further down the page of his press release:

      "On the one hand, as someone trained in internal medicine and oncology, I am all too familiar with the devastating impact of combustible cigarettes on the public health: The 480,000 deaths per year in the U.S. from tobacco-associated cancers, emphysema, heart disease, stroke and the 34.3 million Americans who still smoke combustible cigarettes despite decades of efforts to help them quit. So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear. Though there are some data, both epidemiological and from direct clinical trials, that some electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”) can reduce the use of combustible cigarettes and may be less harmful than traditional cigarettes. What is clear is the explosion of use and nicotine addiction in children."

      If you reduce that mouthful of a paragraph into a few sentences, Sharpless says:

      "I am all too familiar with the devastating impact of combustible cigarettes. Any product that can diminish the use of cigarettes has value. Are e-cigarettes that product? Most e-cigarette users continue to smoke cigarettes [so] the answer is not clear. What is clear is the explosion of use and nicotine addiction in children."

      So if e-cigs were reducing the use of cigarettes, that would be one thing, but, according to Sharpless, that's not clear. Oh, and then we're back to the usual argument about the children (we've covered the FDA's manipulation of this data in another post).

      Scientific Studies

      I was curious, is there any actual scientific basis for Sharpless's claim that most vapers continue to smoke without "diminishing their use of cigarettes?" I've never heard that before.

      There's only one way to find out. Let's look at the scientific studies.

      I scoured PubMed and the internet for studies of dual users of both cigarettes and e-cigarettes. Here is what I found:

      A longitudinal study of electronic cigarette users

      Published in Addictive Behaviors, February 2014

      Results: 22% of dual users had quit cigarettes after 1 month of dual use and 46% had quit after one year. Of those dual users who didn't quit, cigarette consumption dropped by 5.3 cigarettes per day.

      Conclusion: "E-cigarettes may contribute to relapse prevention in former smokers and smoking cessation in current smokers."

      Factors associated with dual use of tobacco and electronic cigarettes: A case control study

      Published in International Journal of Drug Policy, June 2015

      Results: Smokers who started using e-cigs reduced their daily cigarette consumption from 20 cigarettes per day down to 4.

      Conclusion: "Less frequent use of, ECs (electronic cigarettes) was associated with dual use of ECs and tobacco cigarettes." Translation: these people weren't vaping enough!

      How does smoking and nicotine dependence change after onset of vaping? A retrospective analysis of dual users

      Published in Nicotine and Tobacco Research, March 2019

      Results: This study looked at 2,896 dual users. They decreased the number of cigarettes smoked after starting to vape and also decreased their combustible cigarette dependence.

      Conclusion: "Dual use leads to a reduction in the number of combustible cigarettes."

      No Smoking

      Differences between dual users and switchers center around vaping behavior and its experiences rather than beliefs and attitudes

      Published in International Journal of Environmental Research and Public Health, January 2018

      Results: Before starting to vape, the average number of cigarettes smoked in a day was 22. After starting to vape, dual users cigarette consumption went down by 82%.

      Conclusion: "After e-cig initiation, dual users decreased tobacco consumption by 82% and were low-to-moderately cigarette dependent."

      Vaping characteristics and expectancies are associated with smoking cessation propensity among dual users of combustible and electronic cigarettes

      Published in Addiction, January 2019

      Results: This study found that positive attitudes to vaping (rather than negative ones introduced by, oh, I don't know, the acting Commissioner of the FDA) influences whether a dual user keeps smoking or not.

      Conclusion: "Among e-cigarette users who also smoke combustible cigarettes, frequent vaping combined with positive e-cigarette expectancies appears to predict greater smoking cessation propensity."
      Stay Positive

      Changes in use patterns over one year among smokers and dual users of combustible and electronic cigarettes

      Published in Nicotine and Tobacco Research, May 2018

      Results: This study was a little different in that it looked at daily smokers who vaped at least once a week and who did not intend to quit either product. This means they weren't necessarily serious about vaping and might just use it when smoking cigarettes was not possible. After a year, 43.9% were only smoking cigarettes, 48.8% continued dual use, 5.9% quit cigarettes entirely and switched to vaping only and 1.4% quit both products.

      Conclusion: "In this community sample, the majority of dual users transitioned to exclusive smoking. A higher percentage of dual users quit smoking than smokers."

      This was the closest thing I was able to find in all of the studies I looked at (and I looked at every single study that came up on Pub Med using the search term "dual use vaping smoking") to some sort of support for Ned Sharpless's statement, but, despite the outcome, it still doesn't support his contention that "most e-cigarette users continue to smoke cigarettes." Most of these people were smokers who quit vaping.

      Nationwide Survey Reported by Interfax-Ukraine

      Results: Less than 8% of vapers continued to smoke cigarettes and 82% of vapers were ex-smokers.

      No to Cigarettes

      Ned Sharpless's statement that "Most e-cigarette users continue to smoke cigarettes" without "diminishing the use of cigarettes" is just not true. It's not supported by the facts. It's not backed up and, in fact, is contradicted by the scientific studies. And, to make matters worse, his prevaricating statements seeming to link vaping with cancer is, according to at least one study, reducing the chances of dual users actually successfully achieving smoking cessation!

      Pinocchio

      Bottom line: don't expect anything rational out of this FDA Commissioner and don't hold your breath waiting for him to appeal. Unfortunately, the pathological misrepresentation of the facts about vaping seems to have triumphed over reason, science and the free choices of adult vapers.

       

       



      3 Responses

      Jenna
      Jenna

      August 06, 2019

      Yes where does that leave your company? Will we lose you? I am kind of freaking out because I’ve been vaping your products for 5 years now and i can’t vape any other brand. This is all such political bullshit what they are doing to all these vape companies because they are all losing money! No one wants our people healthy in this country! Yet it’s totally fine to sell cigarettes that kill people!! Disgusting. Thank you for such clean pure products.

      Annette Rogers
      Annette Rogers

      August 06, 2019

      Hi Angela,

      The FDA estimates the cost PER SKU (which means a separate cost not just for each flavor but for each nicotine level we offer) will be “around $117,000 to around $466,000.” Industry experts and analysts believe that estimate is low and put the number as high as several million.

      Given this, the cost to get PMTA for our flavors would be tens to hundreds of millions of dollars. Not only could we not afford that but the regulations are not clear cut so gambling that much on the outcome would not be wise.

      We are looking at all of our options, including working together with other companies to jointly gain approval or only offering zero nicotine products. We have just begun a serious review of our options now that the official guidance to the PMTA process was finally released by the FDA. We will do everything we can to continue to offer our products but the outcome is very much uncertain.

      Very best wishes,
      Annette

      Angela
      Angela

      August 02, 2019

      How does KAI’s virgin vapor sit in this situation. Are you going to be able to afford the testing and requirements or will your products be no
      More?

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