Former FDA Center for Tobacco Products director Mitch Zeller will join the advisory board of a pharmaceutical company attempting to shepherd a nicotine inhaler through the FDA drug approval process. The company once shared lies about Public Health England’s 2015 e-cigarette report and the report’s authors.
Zeller will provide regulatory and policy guidance to Qnovia, Inc., a Virginia-based company formerly known as Respira Technologies. Qnovia is seeking FDA Center for Drug Evaluation and Research (CDER) approval for the RespiRX—a nicotine replacement therapy (NRT) product that looks vaguely like a pod-based vape, but is actually a nebulizer that delivers a metered dose of inhalable, nicotine-containing mist.
Inhaled mist delivers nicotine more quickly than oral products like gum or transdermal patches—which means it also has the potential to be addictive like other inhaled nicotine products. The RespiRX is intended to help users to step down their nicotine intake over a 12-week period, and then quit.
Vaping360 reported last year that Respira Technologies engaged in a smear campaign against vaping that included sharing disinformation about Juul Labs and other manufacturers of nicotine vapes that Respira suggested may have caused some of the 2019 “EVALI” lung injuries.
The company also shared lies about British academics commissioned by Public Health England, accusing one or more of them of having financial ties to the tobacco industry. The baseless accusations were shared (and possibly written) by company founder and former CEO Mario Danek.
Last September, Respira Technologies changed its name to Qnovia, Inc., soon after hiring former Altria Group executive Brian Quigley to replace Danek as the company’s CEO. The company’s website no longer hosts the accusations against Juul Labs or Public Health England. Danek is currently the company’s chief technology officer.
Zeller is hardly the first former FDA official who converted his regulatory knowledge and connections into a lucrative pharma job after leaving the federal agency. For example, Zeller’s former boss at the FDA, ex-commissioner Scott Gottlieb, walked out of the FDA and into a Pfizer board position. And current FDA Commissioner Robert Califf’s nomination to the position faced serious questions partly because of Califf’s ties to drug companies.
While at the CTP, Zeller frequently referred to the tobacco product “continuum of risk” that he suggested should guide policy. But during his time as the top tobacco regulator, that didn’t happen. In fact, the most dangerous products—combustible cigarettes—got a pass on the safety and scientific requirements less risky products were expected to meet. And Zeller’s agency never created public messaging that explained the huge risk gap between cigarettes and non-combustible nicotine products.
Mitch Zeller to @cecelou18 of Bloomberg after he has been hired by a pharma company: “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.”
Mitch Zeller to the U.S. Senate: https://t.co/PAUPnRLBJU
— Gregory Conley (@GregTHR) March 31, 2023
In a Bloomberg Law article published today, Zeller said the RespiRX nebulizer could benefit people who currently smoke but will no longer have access to standard cigarettes when the FDA imposes its planned very low nicotine standard. The agency has also announced it will pass a rule banning the sale of menthol cigarettes.
“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,” Zeller said, according to Bloomberg.
The very low nicotine and menthol rules were planned and announced during Zeller’s tenure as CTP director. Further, the only reason e-cigarettes are considered to be “tobacco products” is because the FDA defined them as such in the agency’s 2016 Deeming Rule—a set of regulations overseen and executed by Zeller.
Zeller retired from the CTP last April, after serving as director since March 2013. He was succeeded last July by Brian King. Zeller had also worked at the FDA in the 1990s, becoming as associate commissioner of the agency and director of the Office of Tobacco Programs (which preceded the 2009 Tobacco Control Act, which gave the FDA tobacco regulatory authority and created the Center for Tobacco Products). He later worked at the American Legacy Foundation (now called Truth Initiative) for two years, and then for more than 10 years at private firm Pinney Associates, where he consulted to companies like pharma giant GSK (GlaxoSmithKline), manufacturer of NRT products and quit-smoking drug Zyban.
Photo courtesy the U.S. Food and Drug Administration