Robert BarnesBrian King has finally offered insight into the happenings within the Food & Drug Administration through a recent interview with Politico. This ends a long period of silence since taking up his new position.
King was recently appointed as Director of the FDA’s Center for Tobacco Products division in May 2022.
The interview, conducted by Katherine Ellen Foley of Politico, comes at an incredibly uncertain time for the agency regarding the blunder that has become the outcome of the premarket tobacco application (PMTA) process.
Unsurprisingly, the interview gave little-to-no clarity for vaping companies, as King tactfully avoided providing any of the outcomes that can be expected in the near future.
What Was Said in the Interview
While Dr. King, of course, plays a huge role in just how little light was shed during the interview, it became clear that the right questions were not being asked either.
American Vapor Manufacturers (AVM) petitioned Foley to seek answers for a number of relevant “high priority policy issues” prior to the interview.
These questions range from the issue of the shutdown of multiple vaping businesses, to the repeated warnings to the agency regarding the potential uprising of gray and black markets in the U.S., which can already be seen in Australia.
“Despite our many attempts to initiate dialogue with the agency, neither Dr. King nor Dr. Califf has ever reached out to us for a discussion of any kind. Even as prohibition pressure groups routinely brag about their ongoing access to FDA leadership, the independent businesses and countless American consumers we serve have been left locked out of the conversation,” stated Amanda Wheeler, president of AVM. “Dr. Califf keeps insisting that it’s essential for industry to be included in the agency’s consortia, but he must think that’s Latin for drop dead.”
The above topics were all but ignored during the interview.
Another topic that demanded attention was King’s EVALI debacle, a topic which at this point has become synonymous with the mention of King’s name. This single incident left a perpetual notion in the mind of the public through misinformation.
It is fair to say that this was the birth of the false information that vaping causes lung injuries, one of the most common risks spouted by the anti-vaping public and advocates. And yet, in his very first interview whereby he has the power to rectify his mistakes, he remained silent on the matter.
After this, it is fairly clear that King will continue his history of flying in the face of truth and ethical practices.
Another point that could have been discussed in more detail during the interview is the continuum of risk for tobacco products. This is the the scientific concept that not all tobacco and nicotine-delivering products are equally harmful. King has demonstrated a clear lack of understanding of this hugely important concept in the past. However, he again glosses over his past indiscretions in this latest interview.
“There is no safe tobacco product and that includes e-cigarettes. But safety is also different than risk and there is a continuum of risk with certain products carrying greater risk compared to others,” King stated.
His lack of accountability can easily be considered a glaring flaw given his new leadership role during one of the CTP’s most scrutinized, high-pressure situations.
The State of the FDA
At this point in time, marketing denial orders (MDOs) have been issued to multiple companies, and many have taken up legal action of their own. The result is that it appears the FDA is seemingly unable to even enforce its own marketing orders.
The biggest of these concerns is the fate of companies that have already received MDOs.
“Much to his critics’ dismay, the new chief tobacco regulator won’t say whether the FDA will remove unauthorized electronic cigarettes from store shelves in the near term, even though the agency finalized a rule in 2016 making vape products without marketing orders illegal,” Foley wrote.
This demonstrates the lack of direction that the agency is showing at the current moment. Despite clear outcomes being outlined before the PMTA process began, the agency is either unwilling or unable to carry out its own rulings.
For some, this leaves questions as to what the whole purpose of the arduous PMTA process was in the first place if nothing is going to change.
More Information on the Interview
King’s appointment as the Director of the FDA’s Center for Tobacco Products was met with an admittedly understandable amount of criticism from the vaping community. His history of poor methodology made his name infamous, due to one event in particular.
“Brian King is among the worst choices for CTP that exists,” said one of the many critics in the vaping community. “He has no understanding of tobacco harm reduction or the continuum of risk and has demonstrated a fundamental misunderstanding of what an e-cigarette even is. I expect his reign to be plagued by litigation and that he never accomplishes any of his stated goals for the regulation of the industry.”
Under King’s new leadership, there have been little to no beneficial changes to the FDA’s methodology as of yet. Despite court intervention as a result of slow marketing orders, the agency is still very far behind in terms of producing results.
Politico is a political-focused newspaper outlet based in Arlington County, Virginia. They have covered a variety of aspects regarding vaping news in recent times. Interestingly, despite being seemingly hand-picked by King for this interview, they have appeared to not hold a bias for or against vaping.
To Wrap Up
Dr. Brian King, the Director of the Center for Tobacco Products, has finally broken his silence since his appointment in May 2022. His new leadership position was met with understandable criticism and skepticism from the vaping community, and this interview has only bolstered these worries.
King managed to completely avoid discussing hugely important points regarding his questionable history such as EVALI, as well as the future of companies currently faced with MDOs.
It appears the FDA division will be subject to problematic leadership for the foreseeable future, much to the chagrin of vaping companies.
Versed Vaper Team
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