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FDA Vape News

Time: 2022-05-22

Views: 574

New head of FDA's Center for Tobacco Products sparks huge controversy, once confused vaping pneumonia

Brian King will succeed Mitch Zeller as head of the FDA's Center for Tobacco Products (CTP).


King most recently served as Deputy Director of Research Translation for the Office of Smoking and Health (OSH) at the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention (CDC).


"After a robust executive search, I have selected Dr. Brian A. King as Director of the FDA's new Center for Tobacco Products," FDA Commissioner Califf tweeted. "King brings extensive and impressive expertise in tobacco prevention and control, with over 10 years at the CDC and extensive knowledge of the FDA."


Just a few days ago, the FDA submitted a status report for a product currently under review for a Premarket Tobacco Product Application (PMTA). The regulator said it expects 63% of applications listed in its original priority to be resolved by June 30, 2022, and 72% of applications listed in its original priority by the end of the year. However, the agency does not expect to complete its review of timely submissions until June 2023.


In a House subcommittee meeting following the report's release, Califf said the agency needed more resources to expedite its review of e-cigarettes and avoid hasty decisions that could spark lawsuits in the industry.


"It's an industry with amazing legal capabilities," Califf said. "If we make a mistake in the process, we could be going back years in these procedures."


Many vaping industry leaders said they were dismayed by the announcement and that there is no longer any hope for flavored products other than tobacco.


Matt Meyers, the controversial leader of the movement for smoke-free children and an anti-nicotine advocate, called King a legend and an icon.


During his tenure at CDC, King was responsible for providing scientific leadership and technical expertise to CDC/OSH, the primary federal agency responsible for comprehensive tobacco prevention and control.


King joined the CDC in 2010 as an Epidemiological Intelligence Service Officer, and prior to that served as a Research Assistant in the Division of Cancer Prevention and Population Sciences at the Roswell Park Comprehensive Cancer Center in Buffalo, New York. During his tenure at Roswell Park, his primary research focus was related to tobacco prevention and control.


King has worked for more than 15 years to provide sound scientific evidence for tobacco control policy and effectively communicate this information to key stakeholders, including policymakers, the media and the public.


He has authored or co-authored more than 200 peer-reviewed scientific articles related to tobacco prevention and control, was a contributing author to the 50th Anniversary Surgeon General's Report on Smoking and Health, and was the lead author of the CDC's 2014 Update on Evidence-Based Medicine Country Guidelines, Best Practices for Comprehensive Tobacco Control Programs, and Senior Associate Editor of the 2016 Surgeon General's Report on E-Cigarette Use in Adolescents and Young Adults and the 2020 Surgeon's Report on Smoking Cessation.


He was also the CDC's senior official in the 2019 outbreak of vaping or vaping product use-related lung injury (EVALI) emergency response.


King holds a Ph.D. in Epidemiology and an M.P.H. from the State University of New York at Buffalo. King will succeed Zeller, who retired in April. The FDA has yet to make an official announcement.


But the appointment sparked huge controversy.


Many observers pointed to King's role at the CDC as a botched presentation of a lung disease that emerged in the summer of 2019 -- misleadingly called vaping or e-cigarette use-related lung injury, or EVALI. Three years later, the Centers for Disease Control and Prevention has still not made it clear that the cases were only related to illicitly manufactured adulterated THC pods, not nicotine, as the agency initially suggested.


King's longstanding confusion on tobacco harm reduction cannot be ignored.


He has also been criticized for his comments on e-cigarettes in the past. He was accused of over-emphasizing the harms of vaping products to teenagers at the expense of their harm-reducing effects on adult smokers, and by claiming that e-cigarettes could be modified to contain "heroin, methamphetamine, powdered cocaine and bath salts."


Greg Conley, president of the American Vaping Association (AVA), said that while optimism is always valuable, King's longstanding confusion on tobacco harm reduction cannot be ignored. In his work with the Office of Smoking and Health, King ignored or downplayed the CDC's own survey showing that millions of adult smokers used e-cigarettes as a complete alternative to smoking, while seizing the opportunity to raise questions about the effects of e-cigarettes in youth Ridiculous claim. We hope the FDA hires a theoretician to serve as a so-called neutral regulator, which will lead to renewed interest in this issue among members of Congress.


“Brian King is one of the worst CTP options out there,” said an industry insider who asked not to be named so as not to influence his company PMTA. What shows a fundamental misunderstanding. I expect his management to be plagued by lawsuits and he will never achieve any of the goals he has set out to regulate the industry.”


In a letter to FDA staff, the agency's commissioner, Robert Califf, praised King's expertise, writing:


"He has a broad and detailed understanding and appreciation of the Family Smoking and Prevention Act of 2009, a detailed understanding of the premarket review pathway, premarket tobacco product application, substantially equivalent and modified risk tobacco products, and Experience in interagency scientific review of regulatory documents related to product standards, ingredient testing and reporting, and health information.”


"There is still a lot of work to be done to further prevent people from starting to use tobacco products, encourage tobacco users to quit and reduce the harm caused by tobacco use," King said in a press statement. "During my time at the CDC, I have had the privilege of working with staff in the FDA's Center for Tobacco Products on some important tobacco issues, and I am excited to lead the CTP in advancing these efforts."



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