Steps to address a non-existent problem

 

Yesterday demonstrated the effects of a coordinated effort to discredit one of the most disruptive technologies that has several groups within ‘public health’ worried. Not only for their funding source, which is neither here nor there, but also for the steadily decreasing relevance.

Naturally, the media headlines don’t really get to the bottom of the issue:

FDA puts e-cig makers on notice: Fix ‘epidemic’ teen use or products may be pulled from market

Except, there isn’t really an ‘epidemic’ in teen use. There never really has been. It’s all been skewed out of all proportion by the useful idiots – most notably the Campaign for Tobacco-Free Kids. After all, they were most likely behind the planted news stories about “juul-ing” which subsequently prompted Juul Labs to become yet another public health useful idiot.

Gottlieb has now effectively put brands such as Juul on notice. Buck up, or pack up:

But since electronic nicotine delivery system (ENDS) products had only been recently brought under FDA’s regulatory jurisdiction, few of the foundational rules and guidance documents for defining and clarifying the premarket authorization process for such products had been established at the time I joined the FDA 17 months ago. So, to create this regulatory framework for how we’d properly evaluate the electronic nicotine delivery products, we’ve committed to the development of guidance and regulations, including product standards, that will better spell out the rules of the road. And we’re making significant progress toward achieving these procedural goals.

I’ve written about this before, the “progress” thus far has all been to benefit the pharmaceutical industry.

If we succeed in our overall plan, the public health impact can dwarf anything else we’re able to accomplish in any reasonable stretch of time. It can dwarf the introduction of any new medical technology. Analysis shows that our plan has the potential to drop smoking rates from the current 15 percent to as low as 1.4 percent. It can prevent more than 33 million people – including children – from becoming smokers; avoiding a lot of the death and disease that’s going to be caused by cigarettes. Yet despite our progress, and these metrics, we find ourselves at a very challenging crossroads in the execution of this plan.

Thing is, there are existing products that carry minimal risk already available which – as has been demonstrated in Sweden – has a significant impact on smoking rates, but in the US Snus is treated in much the same way as smoking. Remember, Swedish Match went to the FDA to try to get some leniency in the mandatory labelling which was summarily dismissed – despite reams and reams of evidence.

That’s because we didn’t foresee the extent of what’s now become one of our biggest challenges. We didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers. Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer. Hindsight, and the data now available to us, reveal these trends. And the impact is clearly apparent to the FDA.

Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth.

I use the word epidemic with great care. E-cigs have become an almost ubiquitous – and dangerous – trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.

Thing is, neither the NYTS or the MTF data shows this “epidemic” trend that Gottlieb mentions. In fact, in each of his interviews yesterday, Gottlieb hinted at “secret data” to substantiate his ‘epidemic’ claim. The NYTS data only shows a slight increase in e-cigarette “use” to 11.7% while combustible use continues to decline. Anyone with an ounce of common sense would see this as a win.

This fundamental commitment is why FDA launched our Youth Tobacco Prevention Plan earlier this year.

That plan encompassed a series of actions to stop youth use of tobacco products, especially the rising use of e-cigarettes. Our Youth Tobacco Prevention Plan focuses on three key strategies. First, preventing youth access to tobacco products. Second, curbing the marketing of tobacco products aimed at youth. And finally, educating teens about the dangers of using any tobacco products.

Recognizing that our most immediate tool to address youth use is enforcement, this has been a cornerstone of our approach. And it’s a tool that we’ll continue to deploy, and with growing vigor, to directly address this challenge.

Yesterday, the FDA sent multiple warning letters to retailers and manufacturers related to “the sale and marketing of e-cigarettes to kids”. I do wonder exactly how many of those that got a warning letter is actually guilty of such an offence. After all, the ‘marketing of e-cigarettes to kids’ is a rather broad brush which apparently includes:

misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and cookies.

Naturally, with so many useful idiots continuing to describe various flavours as “kid friendly”, the FDA won’t be running out of targets anytime soon.

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.

Hah, there’s another shot across the bow. In light of this ‘epidemic’ the FDA might very well decide that the extension it granted could be revoked. As Gottlieb went on to say in his speech:

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.

Except that there is no data to suggest there is an accelerating use among youth. This is, quite simply, manufactured outrage as the biggest useful idiot org states in its press release (emphasis mine):

The actions the U.S. Food and Drug Administration announced today to address an “epidemic” of youth e-cigarette use have the potential to make a fundamental difference, but will only have a major impact if the FDA quickly follows up and requires that flavored e-cigarettes that have not been reviewed by the agency be removed from the market because of their appeal to kids, forces changes in the marketing and sales practices of e-cigarette manufacturers that have fueled this epidemic, and requires that all e-cigarettes undergo review by the FDA without further delay.

Anyone who has been paying attention to Gottlieb’s actions since he took office shouldn’t be at all surprised by yesterday’s statement, this was always going to happen.

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.

Along with the VLNC debacle, flavours were always going to be the biggest target, both in combustible tobacco and e-cigarettes.

When we set that comprehensive plan in motion, we also knew we didn’t have all the regulations and guidance that we wanted in place to more clearly define the application pathway for these non-combustible alternatives. While the statute places the burden on manufacturers to show with scientific evidence that the public health standards in the law are met, we also understood that many manufacturers were new to regulation. And many novel products were already on the market. Given the circumstances, we felt that it was important to provide clear, transparent, and predictable rules of the road for industry. And so, for these reasons, we wanted to give the e-cig industry time to come into compliance while we wrote the guidance and regulations to better define and explain how the new products would meet those application requirements. It was an exercise in good government that was taken to accommodate the continued availability of innovations that we believe have potential value.

Except for one fatal flaw, the rules – such as they are – are onerous and ambiguous at best and without guidance, many retailers and vendors wouldn’t be able to complete the PMTA documentation. Guidance which, as Gottlieb notes, wasn’t even complete.

The legal standard for FDA premarket review of a new tobacco product includes consideration of whether the product would be appropriate for the protection of the public health. We must factor in whether these products get kids addicted to nicotine. It’s that simple. And we are taking aggressive actions today to address this.

This may create some obstacles for some adults who also enjoy e-cigs. These are the hard tradeoffs that we’re grappling with. But the youth risk is paramount.

It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.

In order to “prevent youth uptake”, Gottlieb is willing to piss off a large number of adults, many of whom will most likely revert back to smoking. Talk about a classic bait and switch! Invent an epidemic, plant stories to make things sound a lot worse than they are, then announce that you’re going to do something about it. All to rapturous applause.

Today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement blitz and that, collectively, represent more than 97 percent of the current market for e-cigs — JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.

One independent manufacturer and four owned by a tobacco company. Guess what happened next?

Anyone with investments in the tobacco industry must be very happy right now.

Fictional dragon slaying at its finest.

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