The American Vapor Manufacturers (AVM) recently held a forum with the Food & Drug Administration Center for Tobacco Products Director Brian King.
The virtual Q&A, titled “The Future of Vaping in the US: A Conversation with FDA’s Dr. Brian King,” ran roughly an hour. It was aired on February 24, 2023.
The forum marks the first public meeting between King and vaping advocates since his appointment in mid-2022.
As its name indicates, the hope for the forum was to gain an understanding of the agency’s future plans for vaping, as well as get to the bottom of a number of long-standing questions that vaping advocates have had for both the FDA and King himself.
- So-called vaping epidemic is gone
- FDA may authorize vaping products more freely
- CTP to spread proper information on nicotine products among the public
- Reagan-Udall Foundation recommendation response
What Was Discussed?
The forum itself did not cover a great deal, disappointing a number of people tuning in. However, there were certainly some small pieces of information worth discussing.
It quickly became clear King would be characteristically sly. It took only a few moments for the director to avoid answering whether it is unethical to spread misinformation in regards to likening the dangers of vaping to that of traditional cigarettes.
This may have been a clear sign that the rest of the Q&A would not be too enlightening for the future of vaping in America.
One of the biggest of these that King stated is that the FDA is willing to consider easing up on the PMTA process. This would allow more vape products to actually get the exceedingly rare marketing authorization.
The caveat for this is that the FDA will only do so if the so-called ‘youth vaping epidemic’ shows signs of declining.
Of course, the key here is that the epidemic has been widely disputed as being fear mongering jargon and nowhere near what the agency is claiming.
AVM: “Do you acknowledge that U.S. studies, some funded by your own agency, show that millions of people who formally smoked now vape in America?”
Director Brian King: “Yeah, absolutely.”
For anyone paying some semblance of attention to the PMTA process, the FDA is no stranger to moving the goalposts.
Coupled with a seemingly imaginary epidemic, there is no way to know if they will ever release any kind of structured milestones that could help discern whether progress is actually being made in a fact-based way. It is far more likely that the FDA will simply continue reneging.
In fact, King seemingly rewrote his own history in this interview alone. The director claimed that he has never used the term ‘epidemic’ since being appointed at the FDA.
Reagan-Udall Foundation (RUF) Evaluation
This forum certainly came at an interesting time in the agency’s history. Just a few days before King joined AVM, the CTP released their response to the RUF evaluation that was submitted September 2022.
This evaluation was done after the independent expert panel was urged to do so by FDA Commissioner Dr. Robert Califf.
The evaluation included 15 recommendations for the agency to undertake to bring itself up to the standards expected of it. These were deemed necessary steps in combating the shortcomings highlighted during the evaluation.
The FDA’s response seemed to address each of these recommendations, including the steps they may implement to meet each recommendation.
Why Is This Important?
It is very likely that the agency’s response to the RUF evaluation played a huge role not only in what was said by King during the Q&A, but even the forum coming together in the first place. After all, this is the very first time King has met with vaping advocates since his appointment.
Two recommendations in particular seemed to be honed in on as talking points on King’s behalf during the Q&A.
Attention should be drawn to Recommendation 6 and the FDA’s response for it. This is something that directly relates to what was said by King during the Q&A.
- Develop a Clear and Predictable Framework for Application Reviews
King mentioned that the CTP would be willing to authorize more products, should the underage vaping population decline. And as mentioned earlier, this needs to be given a clear and predictable framework so that all parties – the FDA, the vaping industry, the government, and the public – are in the know.
As per the FDA response, a public forum will hopefully be held by the end of 2023 in which the CTP will explain the updated review process. This is something that the entire vaping industry in the US will likely be keen to hear, particularly those hoping to one day acquire authorization.
Recommendation 15 offered a certain amount of irony, given King’s caginess during the interview.
- Improve Transparency
“By spring 2023, CTP will develop an operational strategy that facilitates a culture of enhanced transparency and information sharing, both internally within CTP and externally with stakeholders and the public,” the FDA response reads.
The response continues to state that the CTP plans to initiate more activities to enhance transparency.
This may be one of the driving factors for the AVM forum. This would have been a fairly strategic first public forum as it would have had many vape advocates in attendance, which could have bolstered hopes that the FDA is changing for the better.
Despite actually being a part of the forum, spring of 2023 is around the corner, and yet, King could be considered anything but transparent.
The forum held by the American Vapor Manufacturer and the FDA’s Center for Tobacco Products Director Brian King was held recently, hoping to give insight into the agency’s plans for the vaping industry in the future.
It appeared King’s main talking points – albethey rather unenlightening – were linked to what the CTP had given as their response to the recent Reagan-Udall Foundation evaluation.
With the scorching evaluation highlighting transparency and communication, it may be that this meeting will be the first of many.