The vapor industry may finally be able to be optimistic about the future after 2023’s roller coaster ride.
By Chris Howard
In February of this year, Vapor Voice published my reflections on my past 11 years affiliated with the vapor industry. And while many would say that the vapor industry has been a roller coaster, I remain firm in my belief that a place for vapor products exists in a United States harm reduction strategy. That said, the way things are going at present, it could be years before we see this materialize.
At the end of yet another tumultuous year for the vapor industry and the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), now seems like a good time to review my perceptions from February. What have we seen in 2023? On the one hand, the CTP is clearly reacting to the Reagan-Udall Foundation (RUF) process.
The center is prioritizing stakeholder engagement with, for example, in-person visits between Director Brian King and companies throughout the industry and a recent public meeting on the premarket tobacco product application (PMTA) process. Cynics, on the other hand, would be quick to criticize the center, as flavored disposable vapor products appear virtually unrestricted in retail stores across the nation and the PMTA process remains stagnant. Moreover, the progression to more vapor marketing denial orders (menthol) and the promotion of more bans and prohibitions (flavors, cigars, menthol) are also troublesome.
With the above in mind, let’s reflect on what I wrote earlier this year (see “Head in the Clouds,” Vapor Voice, Issue 2, 2023) and discuss what lies ahead in 2024 and beyond.
Make a Long Story Short
In February, I wrote about suggestions from the RUF for the CTP to provide “more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.”
The good news is that FDA leadership continues to signal this is a priority for the agency. Moreover, the FDA recently held a public meeting in which they provided additional insight regarding the PMTA process that many in the industry have been seeking. Unfortunately, thousands of PMTAs remain pending, and it is unclear how the FDA will handle this existing burden. Expectations remain high for 2024, and I am optimistic we will see progress soon.
You Get Out What You Put In
Reflecting on the difficulty of the PMTA process, I pointed out the exceptionally high standard the FDA has set for premarket review and that companies cannot take shortcuts and expect good results. We all recognize the standards set for tobacco-derived nicotine products are very high, and many applications fell short of even the minimum requirements.
Looking forward, we should expect this high standard to also be applied to PMTAs filed for nontobacco nicotine (NTN) products. The CTP will apply the same rigor when reviewing NTN products—likely with similar results. Industry cannot expect to file short shrift applications and receive market orders. Time, rigor and resources are required to be successful.
Don’t Hold Your Breath
Recall that I suggested it would take the FDA considerable time to increase the efficiency of the PMTA approval process. This continues to be true. And now even more stakeholders are voicing this same concern. Most recently, the Health and Human Services Office of the Inspector General (OIG) published a report titled “The Food and Drug Administration Needs to Improve the Premarket Tobacco Application Review Process for Electronic Nicotine-Delivery Systems to Protect Public Health.”
The OIG audit, in part, focused on the CTP’s inability to review PMTAs within the statutory timeframes and contained a key recommendation “that CTP work with the Office of Personnel Management to obtain direct-hire authority to assist CTP in reaching its full-time equivalent personnel goal and assess the PMTA review process and develop an action plan to resolve the backlog of PMTA applications and achieve compliance with the 180-day statutory timeline.” Ultimately, the report offers yet another series of solutions to what appears to be insurmountable obstacles faced by the FDA.
On the flipside, as the CTP learns more and, hopefully, becomes more efficient in application review, we will most certainly begin to see a more consistent and reliable process. While nothing on the horizon suggests the evidence required to satisfy the “appropriate for the protection of public health” (APPH) standard will lessen, my hope is that we are approaching some level of predictability that will enable companies to refocus on innovation and invest in reduced-harm products.
Two Wrongs Don’t Make a Right
In February, I suggested two wrongs were prevalent in the vapor space. One was the uptick of youth use of vapor products. The other was the sensationalized public health response prioritizing prohibition and often disregarding the opportunity lost by adult smokers seeking alternatives to cigarettes. While we certainly haven’t seen much movement from many in public health, we have seen progress when it comes to youth choices.
In 2019, the National Youth Tobacco Survey (NYTS) reported a shocking 20 percent past 30-day (high school and middle school combined) e-cigarette use. The 2019 report also indicated 27.5 percent of high school students and 10.5 percent of middle school students used e-cigarettes in the past 30 days. Fast-forward four short years and those numbers have decreased dramatically. In 2023, the NYTS reported significant reductions with 7.7 percent overall, 10 percent high school and 4.6 percent middle school past 30-day e-cigarette use. These results clearly indicate that tools like Tobacco 21, public education campaigns and parental engagement work to change youth behaviors.
And it’s worth noting that this reduction occurred despite the proliferation of the noncompliant flavored disposable e-cigarettes available throughout the nation. Unfortunately, instead of lauding success and working to make electronic nicotine-delivery systems more available to adult cigarette smokers, prohibition remains a priority for many, so we still have work to do to prioritize the benefits of reduced harm products for smokers.
When Life Gives You Lemons, Make Lemonade
In February, I indicated, “smokers deserve our efforts to offer satisfying, reduced harm products ….” I still believe that a place for innovation exists in the vapor space. As technology develops and youth vaping numbers continue to decline, new opportunities are inevitable. Of course, the pitfalls associated with long lead time (and expensive) PMTA data development and even longer agency review processes still impede modernization of the category.
That said, the hope is that a better, more predictable, timely and stable review process will take hold. To effect this change, vapor advocates must continue to hold the CTP accountable for implementing reforms in line with RUF recommendations. To be clear, this is a total industry effort. By weeding out bad actors, promoting compliance and continuing to advocate for the lives of smokers, we can succeed in this effort.
I closed my article in February with the hope that I would look back at the end of 2023 to see that the CTP has evolved and used the RUF report to prioritize the continuum of risk and move harm reduction forward. Are we there yet? Unfortunately, no. But that said, I am optimistic that the worst is behind us. Vapor advocates are not giving up, and they don’t seem like they will throw in the towel anytime soon.
More and more smokers are quitting cigarettes with vapor products. And the FDA is gradually making changes to increase efficiency and effectiveness. Hopefully by this time next year, we will be in an even better place with the increased certainty we are seeking.
Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.