Signals of Potential Overreach

Scott Gottlieb, FDA, FDA regulations, over regulation on vaping, signals of overreach

On Wednesday, September 12, Commissioner Scott Gottlieb of the United States Food & Drug Administration released a declaration (link here) that might show to be exceptionally bothersome for the vapor market.

We wish to take you through the most relevant parts of that declaration today, however please do follow the direct link to read it in its whole.

Commissioner Gottlieb mentions rather fairly, near the start of the declaration:

“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 part of the declaration is just unassailable, and it’s exactly what vapor company entities, supporters, and customers have actually likewise been stating for several years. Commissioner Gottlieb continues later on in the declaration:

“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.”

This is where things start to obtain bothersome. Far, no research study yet carried out has actually shown toxicants even approaching, let alone going beyond, those produced in cigarette smoke– not without having actually been peacefully unmasked on the premises of defective method. Readers might remember a research study from a number of years ago with astonishing outcomes about atomizer coils producing such results– however with those impacts triggered by the scientists intentionally misusing the checked hardware in manner ins which customers never ever would.

If these debunked research studies are exactly what the FDA is focusing on when it concerns their dedication to taking a science-based method to vapor items. Most likely, that science-based technique needs to count on real science– not unmasked pseudo-science.

Gottlieb continues:

“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.”

There is, unfortunately, much to be lost by so doing.

This is where Commissioner Gottlieb’s declaration ends up being genuinely uncomfortable; this is not least of all because, as the Vapor Innovation Association mentions, research studies and studies now show that minor intake of vapor items is currently on the decrease (link here)— simply puts, existing enforcement technique is currently working. There is little to be gotten by a knee-jerk overreaction to hyper-sensationalized headings, at this moment.

*curated vape news article


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