FDA’s Scott Gottlieb Releases Concerning Statement

Commissioner Scott Gottlieb of the U.S. Food & Drug Administration released a statement today which is of particular concern to the vape industry. To read the entire statement, please click here. 

The Statement from Gottlieb

Gottlieb said, to start, “Our comprehensive tobacco plan to combat the ill effects of smoking was founded on a central animating principle. That what primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation. While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.”

This is a very reasonable statement, which many in the vaping industry would agree with. Many people falsely assume that it is the nicotine in vape juice, or in cigarettes, that is dangerous. However, it is the combustible nature of the product that is the danger inherent in smoking. However, it is what Gottlieb says next that is scaring many in the industry:

“We need to make sure that we properly evaluate the net public health impact of products like e-cigs before they get marketing authorization from the FDA and that these products meet their regulatory responsibilities. Such products may still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes [emphasis added], and these potential risks require closer scrutiny.”

What? Which study (that hasn’t been proven wrong), says this? This is pseudo-science and is a dangerous precedent to set. The FDA is actually buying into the propaganda and denying the scientific facts, at the detriment of all the good the vaping industry is doing. But some people may say, “wait, I remember a study that said…”. However, these studies have been faulted for bad methodology, where the scientists purposefully misused the hardware to produce fake results. The FDA recently committed to following science in order to make decisions about vaping and vaping regulations. But, if that is the truth, then why are they following these debunked studies? One might even think there is an ulterior motive for purposefully punishing small vape businesses.

Here is another excerpt from the statement:

“We’re announcing the largest ever coordinated initiative against violative sales in the history of the FDA. This is the largest single enforcement action in agency history. It’s aimed at retail and online sales of e-cigarettes to minors.
We sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors. In addition, we issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors.

But we must do more to stem what I see as an epidemic of use of e-cigs among teens, and deeply disturbing trends that show no sign of abating. So, we’re also going to re-visit the compliance policy that we announced last summer to extend the application compliance periods for certain deemed products, including and especially the e-cigarettes that were on the market as of Aug. 8, 2016. Under the current policy, the compliance date for filing applications for such products was extended to Aug. 8, 2022.
We exercised that discretion for ENDS products because, as part of the tobacco and nicotine regulatory framework that we developed, which includes pathways to transition smokers off combustible cigarettes, we wanted to allow time for FDA to establish and more clearly explain the series of appropriate regulatory gates ‒ and for companies to prepare quality applications for new products like e-cigarettes. That’s where the e-cigarettes and other non-combustible products come into play. We wanted to make sure ‒ before we began enforcement of the application requirements ‒ that there was a clear, viable pathway to seek FDA authorization to market alternative products for adult smokers who still sought access to nicotine.

But in view of the accelerating use among youth, we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.
One factor we’re closely evaluating is the availability of characterizing flavors. We know that the flavors play an important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.”

Actually, as many of you know, teen vaping is on the decline. In other words, policy does not have to be changed. Changing policy could, in fact, seriously harm public health. The FDA needs to re-evaluate how they are handling the industry and decide whether or not they want to help or harm the progress of helping smokers quit.

You may also like our article on a new CDC study saying e cig vapor contains no toxic chemicals!

 

Writer, Vaper, Advocate

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7 thoughts on “FDA’s Scott Gottlieb Releases Concerning Statement

  1. When NJ was pushing to ban all flavors of liquid except tobacco/menthol/clove, they cited teen vaping as well. I made the comment to our senators that if they want to “restrict” these flavors to be sold only in vape shops, that would be a more prudent move. Why? Well, vodka comes in similar flavors as vape juice, right? Cotton candy, swedish fish, bubble gum…you name it. But it’s only sold in stores where it can be easily monitored. By that I mean that a teenager walking into a liquor store raises red flags for everyone. So why not go that route with vape shops?
    Honestly, I don’t think there is a single person out there that wants vape products to be readily accessible to minors. But instead of alienating all the folks who have been positively affected by vaping, why not work with us to come to an agreement that suits both sides?

  2. This is continuing the inaccurate (and ignorant) statements by the government. Only lighting it causes disease? DUH! What about chewing tobacco? All I can do is shake my head at these people.

  3. The problem I have with his statement is he is going to punish all sellers of e-cigs and liquid instead of just the ones that are to blame. The convenience stores that are selling these kids the cig a likes. So he is going to make an example out of everyone? Isn’t that like cutting off your nose to spite your face? This government is just plain ridiculous when it comes to vaping.

  4. COPD sufferer who quit smoking cigarettes a year and 10 months ago by vaping. Haven’t had a cigarette since. Health and breathing so much better. By all means regulate the sale to minors, but don’t punish people who find vaping a great alternative to smoking. It’s time the government created regulation by using facts not overreactions. I will find a way to continue vaping no matter what the FDA decides. And also take into account that vaping is creating service and manufacturing jobs.

  5. First of all, the statement “Actually, as many of you know, teen vaping is on the decline ” is misleading, depending on your intended definition of “teen.” The FDA study does show a decrease from the peak usage year of 2015 in vaping among high school students, but there was also a year-over-year increase in vaping from 2016 to 2017, the most recent year for which data is available. Middle school students do show a very consistent decline in use from that peak year, including from 2016 to 2017.

    I think it’s safe to say that when the average person reads the word “teen” they are more likely thinking of high school students than of middle school students and vaping in this group cannot fairly be said to be “on the decline” as there was only one year of decline, from 2015 to 2016 (though a fairly large drop) and the next year saw an increase.

    There is a very important positive outcome to be highlighted here, which is that the youngest group of children seems to be showing a large and consistent decrease in vaping, and indeed in all-source tobacco/nicotine use. That’s worth celebrating, and is a win for the vaping industry. In addition, an overall decline in high school vaping from the peak is a good thing, but let’s not oversell it in a manner that makes the argument open to very easy refutation.

    Secondly, it is concerning that the source you chose to cite is a column from an agenda-focused contributor at The Washington Examiner, an extraordinarily biased outlet that is, fairly or unfairly, seen as a very low quality source by a large portion of the population. Neither of these two things makes the report untrue, or the central message of the study, but they color your conclusions in a counter productive manner. Why not just cite the actual study itself? It’s freely available from the CDC at https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm

    The study has the important results and conclusions, along with the actual data and graphs that add even more credibility to the claims that you could make.

    As a vaper myself, as well as an analyst for the federal government, I would like to see the results of high quality studies being disseminated and promoted. The truth is something we all value, and the more high quality studies like this that we can show to people like the FDA and other skeptics, the better our case is not only for regulatory reform but also for winning the public relations battles that can be nearly as important. And as a very long-time customer of Mt Baker Vapor, I would hate to see this blog being used as an example of the industry falsely misinterpreting scientific results to boost their preferred narrative. The dishonest interests on the side that wants to see vaping destroyed already have sympathetic ears at the FDA, let’s try to avoid giving them additional ammunition for their “the vaping industry is clearly just self serving” arguments.

    I realize that your last paragraph is only a small part of this overall article, but it’s one that most readers will see, and most search engines are likely to pick up on if someone is researching this matter either for personal reasons or for advocacy research.

    Overall it’s a great write-up, and you clearly show that the FDA has some serious credibility issues on this topic. I appreciate your part in pushing back on their agenda. I don’t know how widely read this blog is, but some of us definitely pay attention, and your voice is important. Thanks for what you do.

  6. What we need to do is go after those that aid underage smoking, and vaping…..An idea that I entertained the other day, was that we should roll all our online E-verification systems into one..Do it once, through one place, and obtain a verification number..This will be your number that any retailer can use and check.. After you make a purchase, your number is now associated with it, and all your purchases will be visible in this system..So , if your making normal purchases…No big deal…On the other hand if your ordering excessive amounts of things…You may be one of those that’s aiding this”epidemic”…Somebody out there is apparently doing this, or we wouldn’t have this current situation..The other thing about this verification system is it would allow the FDA, or the public to actually see it…Complete transparency…..They would see your number and what you buy…You realize, you really cant stop someone from doing something…But we could prove that it’s only a select few thats helping it along….

  7. This is like saying curb alcohol flavors. I mean peppermint schnapps attracks or youths. Quit the bull and do your job and monitor e cigs like you do with alcohol. If a store or a web site is selling to minors deal with that store or company. Don’t punish the companies doing the right thing. Do not punish the people that quit smoking do to electronic cigarettes. Thanks to e cigs I haven’t touched a cigarette in five years. Even my Dr. is happy and yes I do have COPD!

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