FDA is ‘exploring ways to accelerate enforcement” of the U.S. vaping industry
The 120-day FDA probe into the possible long-term effects of a nationwide flavor ban on the American vaping industry is now complete. Now comes the time for the bureaucrats to sort through the hundreds of thousands of comments to form some sort of clear path forward. If the joint statement issued on August 2 by FDA Commissioner Scott Gottlieb the Director of the Center for Tobacco Products Mitch Zeller is any indication, vapers should get ready for some very significant changes in the coming months.
The Gottlieb-Zeller statement appears on the FDA blog and has the somewhat foreboding title, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine. While the article begins with a rather positive tone, it quickly devolves into something more conspicuous.
While many vaping enthusiasts may already be aware of Scott Gottlieb as the head of the FDA, Mitch Zeller may have slipped their collective memories. In fact, for those new to vaping in the past two years, they many have never heard of him – ever. As a reminder, Gottlieb is the Trump-appointed FDA Commissioner. He is also a former financial investor in the e-cig company KURE, and the vaping industry had very high hopes that Gottlieb would eventually fight for the right to vape.
Who is Mitch Zeller of the FDA?
On the other hand, Mitch Zeller was appointed by Barack Obama. The fact that Zeller is still working for the FDA even after the election of Donald Trump and the appointment of Scott Gottlieb is truly noteworthy. Why? Because many credit Zeller for the creation, implementation, and management of the FDA deeming regulations that threaten vaping’s very existence to this day. Thanks to these deeming regulations, it is now illegal for vape shop employees to help customers fix or repair equipment, provide taste-tasting of e-liquids, and lots of other silly rules.
Now we have this joint statement co-authored by the allegedely pro-vaping Gottieb and the notoriously anti-vaping Zeller. To their credit, the article begins by pointing out that nicotine is not the real enemy. The smoking of combustible tobacco is. However, since the American public simply is unable or unwilling to make the distinction between the two, the FDA apparently feels pressure to step in and regulate.
“A principal reason people continue to smoke cigarettes — despite the dangers — is nicotine. Our plan recognizes that nicotine isn’t directly responsible for the morbidity and mortality from tobacco, but creates and sustains addiction to cigarettes. It’s the delivery mechanism for nicotine that’s more directly linked to the product’s dangers. That’s why our plan focuses on minimizing addiction to the most harmful products while encouraging innovation in those products that could provide adult smokers access to nicotine without the harmful consequences of combustion and cigarettes.”
Despite this encouraging preamble, the Gottlieb-Zeller article eventually devolves into a lengthy discussion involving everything from kid-appealing e-liquids to the confusion over the Premarket Tobacco Application (PMTA) process. The FDA officials attempt to pacify the American vaping industry by claiming that any and all regulatory decisions will be “science-based.” However, they also freely admit that their positions toward flavored vaping are also being directly influenced by “parents, educators, and health professionals” who are openly hostile towards teen juuling.
“We look at the marketplace for tobacco products today and see increasing concern from parents, educators, and health professionals about the alarming youth use of tobacco products like JUUL and other e-cigarettes. Our mission at the FDA is to protect the public’s health, and we want to assure the public we’re using all of our tools and authorities to quickly tackle this public health threat. We will not allow our efforts to give manufacturers time to file premarket applications with FDA — that are informed by the foundational rules and guidance that we’re now advancing — to become a back door for allowing products with high levels of nicotine to cause a new generation of kids to get addicted to nicotine and hooked on tobacco products.”
Even with “science-based” research showing that juuling is significantly less harmful than smoking, these ill-informed “parents, educators, and health professionals” are clearly the driving force behind the proposed flavor ban legislation. Gottlieb and Zeller also mention in their joint statement that the FDA is "exploring ways to accelerate enforcement" regarding regulatory violations.
Science be damned, the FDA seems poised to pounce on the American vaping industry. And with the ending of the previously mentioned FDA probe, the new official smackdown may be just around the corner.
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