Scott Gottlieb on FDA Deeming regulations: ‘It’s really all or nothing’
When Donald Trump announced his intentions to install Scott Gottlieb as the new FDA Commissioner, many in the vaping community were hopefully optimistic. The FDA deeming regulations as set forth by the previous Obama Administration are largely viewed as nearly impossible to achieve full compliance for the majority of vape shops. Even Clive Bates, a former UK Minister of Public Health, is on-record as claiming that the FDA deeming regulations essentially set the entire vaping industry up for failure.
Gottlieb is a former business associate of Peter Thiel, the founder of PayPal and a major investor in the NJOY e-cig company. But his professional history also includes strong ties to Big Pharma companies like GlaxoSmithKline and a rather odd 2013 article in Forbes Magazine that left many vaping enthusiasts scratching their heads about Gottlieb’s true opinions of the FDA deeming regulations.
Is Gottlieb for or against the FDA deeming regulations?
During his Senate confirmation hearing, Gottlieb insisted that he would recuse himself from major decisions regarding the vaping and electronic cigarette industries due to his former relationship with Thiel. However, this recusal was almost immediately called into question by anti-tobacco lobbyists when the new FDA Chief offered up a nearly 5-year deadline extension to the deeming regulations’ Pre-Market Tobacco Application (PMTA) process. The vaping community may have temporarily won a significant battle, but the war on vaping was still not won.
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In the very same press release, Gottlieb also seemingly took aim at Big Tobacco. In a bold move, the agency announced legal nicotine levels of combustible cigarettes. Again, some vapers were confused. If the new FDA Commissioner is planning to lower nicotine levels in tobacco cigarettes, is he also planning on coming after the nicotine extract of e-liquids?
‘An addictive chemical mix of disease and death’
In perhaps the most coherent explanation of the differences between nicotine and tobacco, Gottlieb recently took to the public speaking trail once again. During a July press conference, Gottlieb read a prewritten statement that tries to educate an American public that has been perhaps intentionally led astray by the anti-tobacco lobby regarding the dangers of nicotine.
“And when nicotine is attached to cigarette smoke particles, it’s not only highly addictive, but an addictive chemical mix of disease and death.“
Like millions of vapers already know, Gottlieb essentially claims that it’s not the nicotine in smoking or vaping that kills people. It’s the nasty, carcinogenic chemicals of combustible cigarette smoke that will. He then goes on to set the stage for what appears to be a more vaping-friendly FDA administration of the future.
“Nicotine is by no means a completely safe and benign compound. But a family and population-focused approach to reducing tobacco-caused disease and death must start from the premise that, as far as nicotine is concerned, the problem isn’t just the nicotine. The bigger problem is the delivery mechanism -- how the nicotine gets delivered. Attach it to smoke particles created by burning cigarettes and the mechanism is deadly.”
Continuing forward in his prepared remarks, Gottlieb then stressed the importance of continued research and innovation into vaping technology as a tobacco harm reduction tool. As if anticipating the glaring question sure to be coming from an ever-critical anti-tobacco lobby, he then clarifies how the FDA can seemingly demonize nicotine by introducing regulations for reduced concentrations in combustible tobacco products while simultaneously calling for e-cig innovation and a delay in the PMTA process. Don’t the two issues contradict one another?
“As a comprehensive public health package, it’s really all or nothing. For example, we cannot make certain accommodations on compliance deadlines or give ourselves the time to put in place foundational rules, or take a different approach to the sunset policy or the provisional applications, if we’re not also pursuing the regulation of nicotine in combustible cigarettes. It’s only in a world where we will work to eventually render cigarettes minimally addictive that we can take on some of the other challenges or provide the greater flexibility outlined here when it comes to e-cigarettes and any other noncombustible products.”
In this closing remarks, Gottlieb states that the United States is at a crossroads. We have a wonderful opportunity to reduce or even eliminate millions of smoking-related deaths in the coming years while preventing future generations of children from becoming addicted to smoking. The FDA is now committing to taking a “hard look” at its entire approach to tobacco while focusing more strictly on nicotine specifically. And electronic vaping devices may just be the alternative nicotine delivery system that can save these millions of lives.
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