The vaping community has been hopefully optimistic by the appointment of Scott Gottlieb as the new Head of the FDA, but we tend to forget that the notorious Mitch Zeller is still lurking in the background. The Obama-appointed Zeller was the key player in the design and implementation of the controversial FDA deeming regulations which threaten to wipe out nearly 99 percent of the American vaping industry.
While Gottlieb recently issued a brief reprieve from the impending Pre-Market Tobacco Applications process by granting a nearly 5-year delay, Zeller seems to be busy drafting new regulations that would theoretically prohibit the sales and distribution of flavored vape juices nationwide. Are the two seemingly opposing issues somehow secretly linked?
The drafted document is entitled The Advanced Notice of Proposed Rulemaking (ANPRM), and it is not yet finalized. While the document is published under the moniker of the Department of Health and Human Services (DHHS), the fine print indicates that the Center for Tobacco Products is the agency actually driving the conversation. And Mitch Zeller runs that agency.
Mitch Zeller, FDA deeming regulations, and vape juice flavor bans
Contained in the drafted version of the ANPRM are brief mentions of flavored e-liquids being potentially beneficial in helping smokers to quit, but it also outwardly blames these same flavors for a perceived rise in teen smoking.
“Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Evidence also shows that the presence of flavors in some non-combustible tobacco products may play a role in helping some tobacco users transition away from combusted tobacco products, which are likely the most harmful currently marketed form of nicotine delivery for an individual user. This ANPRM will seek information on how it might regulate flavors in tobacco products to limit appeal to youth while taking into account the potential role that some flavors may play in helping some users transition away from combusted products. Certain flavors are generally recognized as appealing to youth, such as gummy bear and cotton candy, while others, such as coffee and cinnamon, may not be as obvious. In this notice, FDA would request information on how best to regulate flavors in tobacco products to limit appeal to youth and prevent youth initiation and use of tobacco products.”
Oddly, a recent report issued by the CDC entitled Tobacco Use Among Middle and High School Students – United States, 2011-2016 indicates that teen smoking is on the decline in recent years. The conflicting arguments of this initial ANPRM draft designed around alleged increases in teen smoking rates compared to the CDC report that suggests the opposite point of view begs the question:
“So, Mitch. Which is it? Is teen smoking on the rise or is it on the decline? And shouldn’t you be thanking the vaping community rather than attempting to regulate it out of existence?”
And let’s not forget, during a June 2017 press conference referencing these same CDC statistics, Commissioner Gottlieb praised the FDA deeming regulations for the rapid decline in teen smoking rates for 2016. Gottlieb never gave an ounce of credit to the American vaping industry whatsoever.
With the release of the new ANPRM draft, many insiders of the vaping community are now beginning to secretly wonder. When Gottlieb announced a delay of the PMTA protocols until 2022, was he throwing a bone to the U.S. vaping industry? Or is something more devious underway?
What is Scott Gottlieb’s role in this latest vaping ban nonsense?
Many are speculating that the arrival of the ANPRM document might be signaling that the Gottlieb’s FDA may no longer be worried about those nasty FDA deeming regulations with their uber-expensive and ultra-time-consuming PMTA process. Perhaps all along, the true mission of Gottlieb, Zeller, the FDA, and by extension Donald Trump is to eradicate the vaping industry in one fell swoop by simply outlawing flavored e-liquids altogether. After all, if a FDA flavor ban goes into effect, the PMTA controversy essentially goes away.
To be clear, the ANPRM document is only a draft. If history teaches us anything, it’s that these types of regulatory documents often go through an almost endless series of rewrites. But is that a good thing or a bad thing? Taking a look at the new tax regulations passed just before Christmas, those seemed to get worse rather than better the longer the process dragged on.
And isn’t it weird that Mitch Zeller is still hanging out in the halls of the FDA after Trump’s apparently pro-vaping appointment of Scott Gottlieb as his boss? On both issues (taxes and vape bans), perhaps only time will tell.