The FDA is getting rid of the little companies that created the vaping industry while using the big companies to take the industry to new heights of scientific overkill.
By George Gay
Amanda Wheeler is angry.
I know this because I listened to her presentation on day two of the Global Tobacco and Nicotine Forum (GTNF), which was held in London in September 2021.
I know, also, that she has every right to be angry—very angry. But despite the provocation she has suffered, her anger was not immoderate or discourteous. It was a controlled, calmly articulated anger—the sort that, if it had been aimed at me, would have had me checking where the door was. Indeed, I think I checked anyway—you can never be too careful.
Who is Wheeler? She is the founder and owner of the U.S.-based e-liquid manufacturer and retail store JVapes and president of the American Vapor Manufacturers’ Association.
Who is she angry with? I think it would be fair to say she is angry with a lot of people and organizations, but mainly she is angry with the U.S. Food and Drug Administration, some politicians, large swathes of the U.S. media, “scientists” who put their names to the findings of flawed research into vaping and people who use their wealth and influence to spread misleading stories about vaping, sometimes based on flawed research.
Why is she angry? Well, the shenanigans and pettifoggery the above organizations and individuals have been getting up to has resulted in almost the entire U.S. vaping industry being faced with an existential threat. And just in case you have been on an interplanetary mission for the past 10 years, let me explain why this is, to say the very least, disappointing. Vaping comprises a harm reduction tool that actually works—that, because it mimics reasonably closely all the enjoyable and satisfying aspects of tobacco smoking but at a tiny fraction of the risk, provides people who want to quit smoking with an exit route that leads to a significantly improved quality of life. To put things in perspective, I am told, even by those opposed to vaping, that in the U.S., more than 400,000 people die of smoking-related diseases each year.
Undermining an Obvious Solution
And yet, outside the vaping industry and the village of smokers and vapers, vaping generally goes down like a lead balloon in the U.S. Why? Well, a cynic such as me can think of a whole raft of reasons, none of which reflect well on the intellects or ethics of those opposing vaping. But it’s the inconsistency I simply cannot understand. Why would politicians charge the FDA with reducing the problems caused by tobacco smoking, but then, when a solution—vaping—dropped into its lap, undermine that solution wholesale? It makes no sense. Why, when given the current circumstances, you have to assume politicians wanted smoking—and the flow of money it draws in—to continue, did they ask the FDA to intervene in the first place? After all, they didn’t, as far as I know, ask the FDA to intervene in the case of alcohol, even though the U.S. comes fourth on the worldwide league table of populations who get drunk the most.
“Oh, but what about the problem of vaping among young people?” will come the anguished cry from some politicians, the FDA and an army of other organizations. Well, let’s examine the facts. I am told that about 11 percent of U.S. high school students recently reported using a vape once in the previous 30 days while 3 percent of U.S. high schoolers reported vaping nicotine daily. Also recently, about 20 percent of 10th graders and about 34 percent of 12th graders reported using alcohol in the previous 30-day period while about 9 percent of 10th graders and 20 percent of 12th graders reported being drunk in the past 30 days. By the way, for the sake of our interplanetary travelers, I should include the reminder that it is not possible to become drunk by vaping nicotine.
Perhaps the answer to these inconsistencies lies in tradition or tradition’s running mate, inertia. In Australia, which comes top of the worldwide league in respect of the number of times people report getting drunk during any one year and in respect of seeking emergency medical treatment because of alcohol poisoning, you can buy alcohol at drive-through bottle shops. But you must have a prescription to buy nicotine-based vaping products, and you can buy them only from pharmacies or through the Personal Importation Scheme. Come on, you know it makes sense.
A Flawed Process, Not Flawed Products
In can be illuminating to discover what some individuals and organizations think of as making sense. In a piece on Open Access Government on Dec. 13 titled, “Tobacco control and prevention efforts in the U.S.,” the director of the FDA’s Center for Tobacco Products (CTP), Mitch Zeller, was quoted as saying, in part, “After receiving millions of premarket applications [premarket tobacco product applications—PMTAs] for e-cigarette products last year, the agency has recently issued marketing denials [marketing denial orders—MDOs] for over one million flavored ENDS [electronic nicotine-delivery systems].” And later, he was quoted as saying, “… R.J. Reynolds Vapor Company [RJRVC] … received marketing authorization in October 2021 for an ENDS device and tobacco-flavored e-liquid pods after FDA determined ….” This, a more or less one-in-a-million approval rate, is what the FDA seems to see as a success.
OK, it would be easy to accept the FDA’s glee at having blocked a million products if these products had been flawed, but, on any reasonable judgment, this seems not to be the case. The million products seem to have fallen foul of a flawed process, one in which the goalposts might have been moved after applications were submitted. I would direct anybody interested in what went on to a piece in Filter by Alex Norcia, “FDA Memos Reveal its ‘Fatal Flaw’ Rejection Plan for Flavored Vapes” (see https://filtermag.org/fda-memos-flavored-vapes). As Norcia makes clear, the situation is complex, but some things seem reasonably clear, at least to the cynic in me. The FDA seems to have found an expedient way of getting itself out of a trap created by a pincer movement in which, on one side, anti-vaping organizations, using the courts, had forced onto the FDA a totally unrealistic deadline for approving or denying millions of vaping product marketing applications while, on the other side, baying politicians had picked up the scent of a populist crusade—one opposed to vaping flavors.
Simply put, the vaping scene in the U.S. seems to be chaotic. The regulatory environment in which the vaping industry operates should and could be effective but simple. After all, it concerns a consumer product, not something to blast you into interplanetary space. But this environment has instead been rendered enormously complex and chaotic. And, as a consequence, the industry has been rendered at one and the same time both chaotic and, product-wise, moribund, an almost miraculous misachievement.
Playing Catch-Up
The odd thing is that things could be worse. At present, what is happening in the U.S. amounts to a phony war. While the existential threat exists, within the chaos and complexity, life goes on, in part covered by a legal fudge. Vaping product owners and vaping shops are still selling some of their products, and consumers are still able to access some of their favorite brands. This is because some products, especially tobacco-flavored and menthol-flavored ones, while not having been approved, have not been issued with MDOs, even though the deadline for PMTA decisions has passed. In addition, some MDOs are the subject of court challenges, some products that have been the subject of MDOs have been left on the market, presumably because their owners figure it is going to take time for the FDA to catch up with them, and some brand owners have switched their e-liquid formulations from tobacco-derived nicotine to synthetic nicotine, which does not come under the authority of the FDA.
Not yet, it doesn’t. At his FDA commissioner nomination hearing on Dec. 14, Robert Califf reportedly said there were in synthetic nicotine two enantiomers of nicotine, one of which did not occur in nature and whose properties were not known. He then went on to say that because of this, it would be necessary to close this loophole, which I take to mean he thought it was time for the FDA to take authority over synthetic nicotine. There are at least three problems with this as far as I can see. Firstly, synthetic nicotine does not comprise a loophole. It has been around long enough that the FDA must have been aware of it and have chosen not to include it when it performed its nontobacco-into-tobacco deeming sorcery.
Secondly, Califf was apparently saying synthetic nicotine and tobacco-derived nicotine were different, so they had to be treated the same, which is a non sequitur. Thirdly, it seems as though, in saying what he did, Califf has created a false and ultimately unhelpful dichotomy. I am told by people who know about such things that the important issue is not about the difference between tobacco-derived nicotine and synthetic nicotine but between nicotine that complies with U.S. and European pharmacopeias and nicotine that doesn’t comply. I believe that in some cases, synthetic nicotine outperforms tobacco-derived nicotine in this regard.
Favoring the Big Guys
There is one other notable thing about this fatally shambolic situation, and that concerns the wedge that is being driven between the major tobacco manufacturers and the smaller vaping companies. During a panel session at the GTNF mentioned at the start of this piece, somebody asked how long the U.S. public should be patient with the FDA while it got its vaping act together. In response, another participant seemed to defend the FDA, in part by saying that even given most products fell foul of the agency’s PMTA process, the public would still have the choice of two products. Both of these products were owned by major tobacco companies—one was an oral product and one was IQOS.
I cannot help feeling that though the PMTA process favors the major tobacco manufacturers and is clearly helping them in their competition against the smaller companies, the majors need to look at and be seen to look at the interests of the smoking and vaping public, which are clearly not being served by the FDA. Like Wheeler, they need to state publicly that what is going on is counterproductive. As somebody once said in relation to another matter, if you economize on the foundations of a building and spend the money saved taking it higher, sooner or later, the whole edifice is going to come tumbling down. And this is what the FDA seems to be about. It is de facto getting rid of the little companies that formed the foundations of the vaping industry while using the big companies to take the industry to new heights of scientific extremism and overkill.
Just how dangerous such a strategy can be has been demonstrated by the fact that one of the two “products of choice,” IQOS, has been banned from the U.S. market over a patent dispute. Does anybody think it’s okay to reduce consumer choice to one oral product—and, of course, let’s not forget the RJRVC product—no matter how good it might be? We’re talking more than 400,000 lives a year, remember.
To my way of thinking, the major manufacturers need to join Wheeler and become constructively angry.
