Mitch Zeller, the former head of the FDA Center for Tobacco Products, is going to become a member of the advisory board of a pharmaceutical company that is trying to get FDA approval for a nicotine inhaler. Previously, the firm disseminated false information on the authors and Public Health England's 2015 e-cigarette report.
Zeller will advise Qnovia, Inc., a Virginia-based business that was formerly known as Respira Technologies, on regulations and policy. For the RespiRX, a nicotine replacement therapy (NRT) device that resembles a pod-based vaporizer but is actually a nebulizer that provides a metered dose of inhalable, nicotine-containing mist, Qnovia is requesting FDA Center for Drug Evaluation and Research (CDER) approval.
Like other inhaled nicotine products, inhaled mist has the potential to become addictive since it delivers nicotine more quickly than oral treatments like gum or transdermal patches. RespiRX users are supposed to gradually reduce their nicotine intake over a course of 12 weeks before quitting.
Smear campaign directed on Juul, Public Health England, and vaping
Vaping revealed last year that Respira Technologies launched a defamation campaign against e-cigarettes, including spreading false information about Juul Labs and other nicotine vaporizer makers, which Respira claimed could be responsible for some of the 2019 "EVALI" lung ailments.
Additionally, the business disseminated false information on British academics that Public Health England had commissioned, alleging that one or more of them had connections to the tobacco industry. Mario Danek, the former CEO of the company, shared (and possibly wrote) the unfounded claims.
Soon after Danek was replaced as CEO of Respira Technologies by Brian Quigley, a former leader of the Altria Group, the business changed its name to Qnovia, Inc. in September of last year. The allegations made against Public Health England and Juul Labs are no longer available on the company's website. Currently serving as the company's chief technology officer is Danek.
The FDA's "revolving door" policy
Zeller is by no means the only former FDA employee to leave the government agency and turn his regulatory expertise and contacts into a lucrative pharmaceutical position. For instance, Scott Gottlieb, the former commissioner of the FDA and Zeller's boss, left the agency to take a board seat at Pfizer. Furthermore, there were major concerns raised about incumbent FDA Commissioner Robert Califf's nomination for the role, in part due to Califf's connections to pharmaceutical corporations.
Zeller often mentioned the "continuum of risk" associated with tobacco products when he was at the CTP, suggesting that this should inform policy. But that did not occur while he served as the principal tobacco regulator. In actuality, the safety and scientific standards that less hazardous items were supposed to achieve were waived for the riskiest products—combustible cigarettes. Furthermore, Zeller's organization never disseminated public information outlining the significant danger difference between non-combustible nicotine products and cigarettes.
Zeller stated that the RespiRX nebulizer could help smokers who will lose access to regular cigarettes when the FDA implements its proposed extremely low nicotine standard in a Bloomberg Law story that was published today. The agency also declared that it will enact a regulation that forbids the selling of cigarettes with menthol.
According to Bloomberg, Zeller stated, "The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product."
During Zeller's time as CTP director, the extremely low nicotine and menthol regulations were developed and made public. Furthermore, e-cigarettes are only regarded as "tobacco products" since that is how the FDA categorized them in the 2016 Deeming Rule, a set of rules Zeller is in charge of enforcing.
After acting as director of the CTP since March 2013, Zeller retired in April of last year. Brian King succeeded him in July of last year. Prior to the 2009 Tobacco Control Act, which granted the FDA tobacco regulatory authority and established the Center for Tobacco Products, Zeller had also worked for the FDA in the 1990s, rising to the positions of assistant commissioner and head of the Office of Tobacco Programs. Later, he spent two years working for the American Legacy Foundation (now known as Truth Initiative) and then over ten years working as a consultant for Pinney Associates, a private organization, where he advised businesses like GSK (GlaxoSmithKline), a major pharmaceutical company that makes Zyban, a medicine used to help people stop smoking, and NRT products.
