The Vape Company at the Center of the FDA Storm

    On the outskirts of Dallas, Texas, at an unassuming warehouse, two young men in scrubs carefully weigh out liquid nicotine. All they do is measure, actually. They move back and forth in a clean room, a carefully engineered space intended to keep out unwanted airborne particles. It almost sounds windy when you open the door.

    A computer spits out what they need—this much propylene glycol, this much vegetable glycerin, this much flavoring—before the e-liquid barrel moves onto a gyroscopic mixer. (Imagine a washing machine, and you won’t be too far off.) From there, about a dozen or so employees will bottle and label the e-liquid in an assembly line, readying it for either immediate distribution or storage.

    All the while, each ingredient has been tracked and has the potential to be traced—so, if necessary, you could take an individual bottle and know exactly what’s in it. Each label corresponds to a batch number, and each batch number corresponds to the respective batches of propylene glycol, vegetable glycerin, liquid nicotine and other ingredients in the final e-liquid.

    None of this meticulous handling is technically required.

    The hybrid scenario here—where e-liquids are created, extensively tracked, and distributed in the same place—is not that common in the vaping industry. It is, in many ways, a model constructed by Todd Wages. This is the company he co-founded: Triton Distribution. The vapor distributor—large-scale, but no behemoth—produces and ships e-liquid for a handful of companies like Jimmy the Juice Man, Vapetasia, Suicide Bunny and Cold Fusion.

    But you enter Triton’s building, the facility seems to be more of a run-of-the-mill office. A few sales representatives in headsets make phone calls and complain to their colleagues about the weather. It’s only after you walk through a door into the back that you see the unusual process moving, more or less, in a circle. A batch created in the clean room travels first to the nearby gyro mixer, then into the room where workers bottle it, and finally into a storage space or onto a palette.

    For all the frequent talk of an unregulated and irresponsible industry, the precision is striking. And it doesn’t stop there: Triton is also picky about who it does business with. The company monitors the down-market, for example, with a retailer’s agreement that explicitly bars sales to minors. If a retailer were caught selling underage customers, Triton would have the right to confiscate its products.

    The company frames all this technology and meticulous handling as consumer protection for the former smokers who use its products. None of it, however, is technically required.

    The Food and Drug Administration (FDA), which officially “deemed” vaping products and e-cigarettes under its authority in 2016, does not have those sorts of stringent rules—at least not yet. While vapor manufacturers must register their ingredients with the agency, other regulations remain notoriously up in the air. So with little, if any, direction from the FDA, Wages believes that he has built a template for self-regulation—an evolving process, he once figured, that could be considered by the agency for the basis of some more formal regulations.

    A legal battle had begun that many observers think could redefine the vaping industry.

    “We want to be regulated,” Wages told Filter. “We want to be regulated with guidance. We’ve simplified the process, as much as we could, for future regulations. Anyone can come to Triton and see the whole process under one roof.”

    At Wages’ invitation, I did just that. When I went to Triton on February 1, a winter storm threatened to cancel my flight. No less dramatically, a legal battle had just begun that many observers think could redefine the vaping industry. The day before my visit, the Fifth Circuit Court of Appeals had heard oral arguments for Triton’s lawsuit against the FDA. The company filed it because the agency had determined, in mid-September, that Triton’s flavored vaping products could no longer be sold on the US market. 

     

    Trying to Make Sense of the FDA

    Todd Wages, who co-founded Triton with a friend, has a familiar origin story. Born and raised in Oklahoma, he stopped smoking by accident a decade ago, when he first tried an electronic cigarette at the age of 29. He described what happened next as an “evangelical experience.”

    Vaping was a lifesaver that quickly became his life: He opened a vape shop with some partners, and in time, he began working for Wolfpack Wholesale, a distributor that he pushed worldwide. By 2016, he had formed Triton.

    Wages, who often sports a backwards hat, wants to “do things,” he said, “for the right reason.” That hasn’t been easy.

    They don’t cling to a delusional belief that regulation can be avoided; they simply think the FDA has messed up, time and time again.

    A well-worn saga has unfolded over the past few years. By September 2020, vape producers had to submit individual premarket tobacco product applications (PMTAs) to the FDA for every single product in their inventory. These had to show that products would be “appropriate for the protection of public health” (APPH)—meaning, in most people’s interpretation, more likely to help adults swap smoking for a safer alternative than to introduce a new generation to nicotine.

    It’s a threshold that many companies have argued only became clear in retrospect—that is, after the FDA denied their applications. Internal memoranda made public in court proceedings suggested that the agency, deluged with literally millions of applications, applied a catch-all method to slash through some of its paperwork. The agency seems to have looked for longitudinal cohort studies and randomized control trials (RCTs)—two types of onerous, expensive scientific studies. Applications that did not contain at least one of them—those from small- and mid-sized companies, rather than the giants with well-funded science departments—were summarily nixed.

    The FDA has rejected or denied millions of applications—up to 99 percent—and has tens of thousands left to evaluate, including the companies with the largest market share. The agency has authorized just a handful of products: the high-nicotine Vuse Solo, along with two tobacco-flavored cartridges, and a couple of other high-nicotine, tobacco-flavored products made by Logic. Both are owned by Big Tobacco: Vuse by R.J. Reynolds, and Logic by Japan International Tobacco (JTI).

    There seems to be a widespread misconception that vape producers are either large, well-resourced companies with ties to the tobacco industry or fly-by-night opportunists with anti-government leanings, mixing e-liquid in their parents’ basement.

    Triton is neither. And in my experience, vape shop owners and manufacturers tend to be similar to Wages: They don’t cling to a delusional belief that regulation can be avoided; they simply think the FDA has messed up, time and time again.

    “The bar was always a cigarette. The goal was to make a product that’s safer than a cigarette.”

    One of Wages’ main sticking points is what the FDA chooses to focus on. It has not differentiated, for example, between the pod-based or disposable products favored by youth (some adults use them too) and the open-system vapes preferred by many adults (and clearly not preferred by teenagers). Neither has the agency made it a priority to see how companies like Triton operate. Jon Rose, the general manager at Triton, told Filter that the FDA visited the facility only once to do a spot inspection. (Through a spokesperson, the FDA told Filter that it “doesn’t comment on pending or ongoing litigation.”)

    Wages also contends that the agency’s authorizations have not provided a step-down cessation channel, and that an obsession with flavors has led policymakers to overlook vaping’s unique ability, through gradual reduction of dosage, to help people who wish to quit nicotine entirely.

    “The bar was always a cigarette,” he said. “The goal was to make a product that’s safer than a cigarette.”

    It’s a goal that seems to have been lost long ago. Certainly, few political or media portrayals of vaping’s alleged risks make a direct comparison with those of smoking—the difference that defines vaping as harm reduction. And when high levels of nicotine are routinely characterized as a problem, despite the substance’s benign risk profile, the FDA’s decisions make even less sense to Wages.

    “Now the FDA has gone ahead and authorized the Vuse Solo, which uses 50 milligrams of nicotine,” he said. “Triton’s most popular products are 3 milligrams. That’s almost 20 times less nicotine, now, than an FDA-authorized product.”

     

    A  Hotly Anticipated Verdict

    In mid-October, about a month after the FDA issued its denial, the Fifth Circuit Court of Appeals granted Triton a full judicial stay. This allows the company to continue selling its products as its lawsuit remains active, and is the reason the gyroscopic mixer was still whirring when I visited.

    When issuing the stay, a panel of judges wrote an impassioned opinion—20 scathing pages—that slammed the FDA for botching its regulatory responsibilities. The agency, they said, had “simply ignored Triton’s [marketing] plan” and “pull[ed] a surprise switcheroo by requiring long-term studies that manufacturers did not anticipate.”

    They added that “the public-interest factor [was] at worst neutral” if Triton’s products stayed on the market. Youth vaping, in other words, would not go up should Triton remain in business. They determined, too, that Triton would “ultimately succeed” in its petition.

    Success, however, is a tricky word.

    Months later, in late January, a different group of judges in the Fifth Circuit heard oral arguments from Triton and the FDA. The signs from these judges, such as they were, sounded a little more equivocal.

    “You have to believe that somebody somewhere has some sense.”

    As Filter previously reported, there are essentially three potential outcomes: The court upholds the FDA’s denial, and Triton can no longer sell its products; the court vacates the marketing denial order and enjoins the agency from taking adverse action against Triton’s application for some time to allow the company to complete long-term studies (while potentially continuing to sell its products in the interim); or the court vacates the denial but does not enter an injunction, putting the PMTA back under review to be reevaluated over an indeterminate period.

    Though dozens of other manufacturers have filed similar lawsuits, alleging the agency acted “arbitrarily” and “capriciously” in reviewing their respective PMTAs, many observers are paying particular attention to Triton, given the initial judges’ opinion and the fact that the decision will likely be the first verdict of its kind. Whatever happens could serve as a kind of precedent, a reasoning that other federal appeals judges across the country might take into consideration.

    In the end, the court could conclude that the APPH standard the FDA applied was not exactly within its regulatory power. The bar to entry, after all, was that these vaping products must be safer than cigarettes—not that they would necessarily lead a smoker to quit.

    “You have to have some hope,” Wages said. “You have to believe. You have to believe that somebody somewhere has some sense.”

     


     

    Photograph by DreamQuest via Pixabay

    The Influence Foundation, which operates Filter, has received grants from Reynolds American, Inc. Filters Editorial Independence Policy applies.

     

    • Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism Review, The Los Angeles Times and The New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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