Food and Drug Administration Commissioner Scott Gottlieb, M.D. released an announcement today regarding its ongoing policy to address the “epidemic” rates of e-cigarette use among youth, stating, “We’re committed to announcing a new action plan by mid-November that will set forth a series of new, forceful steps to firmly confront and reverse the youth addiction trends that are at epidemic levels.”
Dr. Gottlieb said his message to the vaping industry was clear – “Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use.”
Sounds like a good step forward, right?
Many vaping manufacturers agreed that preventing youth vaping should be a priority. And according to the FDA, the proposals received from the big five closed-system vaping manufacturers ranged from raising the minimum age to purchase tobacco to 21, to removing flavors from the marketplace that are appealing to kids (basically anything that’s not tobacco or menthol flavored), and enhancing age verification processes at the retail level. While this isn’t as draconian as the FDA flavor ban proposal that’s on the table, it’s still extreme.
Was there a reason that only the big closed-system companies were given a seat at the table? Actually yes. Back in September, the FDA made another policy announcement about how they would be addressing the youth vaping epidemic going forward. One of the FDA’s findings was that “The biggest youth use seems to be among cartridge-based e-cigarettes, and not the open-tank vaping products. So, we’re exploring policy options that could let us adjust the policy steps we take to account for different product use patterns between kids and adults. Our focus is on the products that are being misused by minors.”
Curbing youth vaping is a priority. And it should be.
But here’s the problem: The policy recommendations of removing flavored e-liquid from the market, and requiring e-liquid manufacturers to go through a costly and lengthy FDA approval process for each individual flavor while their entire business is out on hold will most likely decimate the e-liquid industry. Which seems pretty unfair, since the FDA has already made the determination that refillable tank systems (and the e-liquid that that fills them) are not what appeals to underage vapers.
And who steps in to fill the void when your favorite e-liquid manufacturer is wiped out? That’s right, Big Tobacco, and Big Vaping – the very same five companies that are “assisting” the FDA in their youth vaping prevention policy recommendations.
Soupwire reached out to at the FDA for details on how the more aggressive youth anti-vaping policy would impact e-liquid-only manufacturers, whether or not the FDA had any plans to invite e-liquid-only manufacturers to be part of the policymaking discussions, and whether or not the FDA had any concerns that three Big Tobacco companies, and the two largest closed-system manufacturers (Juul and Fontem Ventures) were making policy recommendations that could potentially wipe out the majority of the current e-juice industry (which is comprised of many small businesses and artisanal manufacturers) — without those companies having a seat at the table.
Michael Felberbaum, a Press Officer in the FDA’s Office of Media Affairs, responded, “Unfortunately I don’t have anything additional to share beyond the statement.”
There’s still a lot that’s up in the air right now.
Stay tuned, we’ll bring you all the breaking news on vaping and the FDA deeming rule as it happens.