Amid a months-long wait for clarity on the future of vaping in the United States, people on all sides of the tobacco harm reduction debate are growing anxious.
On January 14, a collection of public health nonprofits and tobacco control groups—including the Campaign for Tobacco-Free Kids (CTFK), the American Heart Association and Truth Initiative—sent a letter to Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products (CTP). The groups—many of which are funded by billionaire Michael Bloomberg and all of which want to clamp down on vaping—urged the agency to “expedite” its decisions on products that remain on the market without authorization. It had been more than four months, they noted with palpable agitation, since CTP had blown past court-ordered deadline to review vapor companies’ premarket tobacco product applications (PMTAs)—submissions, the FDA has stressed, that would be considered on a case-by-case basis.
In short, they called for the FDA to “complete [the] public health review of all e-cigarettes without further delay”; “issue marketing denial orders [MDOs] for all non-tobacco flavored products including menthol-flavored products, based on the continuing adverse impact of those products on public health, and particularly their impact on youth”; “immediately prioritize enforcement against e-cigarette products that continue to be sold without marketing authorization,” if they are “flavored products with the highest market shares” or “products with the highest prevalence of youth usage; and “identify, on an on-going basis, the products, and their flavors, that receive MDOs, including all menthol-flavored products.”
The letter was hardly a surprise.
“Such groups going off on tangents evincing both ignorance and arrogance, and ignoring the sort of risk-benefit analysis and human rights that should be such a key part of public health policy making, is disappointingly consistent behavior,” David Sweanor, an industry expert and chair of the advisory board for the Centre for Health Law, Policy and Ethics at the University of Ottawa, told Filter.
The trouble is, with youth vaping rates decreasing, the landscape isn’t getting better for prohibitionists.
Their message hasn’t changed: We must prohibit everything we can to keep vapor products out of the hands of teenagers, even though countless experts have praised their ability to help adult smokers transition to a safer alternative.
The trouble is, with youth vaping rates decreasing—and the FDA having set a precedent of sorts by authorizing one vaping product and not yet denying others made by the biggest companies—the landscape isn’t getting better for prohibitionists. These nonprofits have decided that now is the time to ramp up the pressure on the FDA, which is in the position of trying to regulate overnight a robust, lucrative industry that has existed for more than a decade.
Sensationalist stories of the youth vaping “epidemic” have dominated the media over the past few years, but we will soon enter new territory. By the end of January, federal judges will be evaluating not the seriousness of youth vaping but rather determining if the FDA failed to act in the bounds of the law. The distinction is important: What’s about to be at stake is the FDA’s process itself.
Two things are happening concurrently: While anti-nicotine, prohibition-leaning entities are pillorying the FDA for ignoring a dwindling youth vaping “crisis,” manufacturers (along with vapers and harm reductionists) are criticizing the agency for not treating them fairly. The political, mainstream attention for the former tends to shroud the latter.
To understand all this, we need to recall the origins of the bureaucratic mess: Manufacturers had until September 2020 to file their PMTAs; the FDA had a further year to decide on the applications it received.
A federal judge had set that time line after the organizations behind the recent letter sued the FDA to move the PMTA dates up; the rapidly approaching deadline meant that many small- and medium-size vape producers had to send in whatever they had. The FDA issued little-to-no practical guidance, and smaller companies banded together to send in millions and millions of rushed, sometimes half-completed PMTAs for each individual product variation.
Probably looking to slash through the amassed paperwork, the FDA then created a fresh “Fatal Flaw” standard that would determine if a PMTA could remain under review. This allowed the agency to deny thousands of applications based on whether or not they contained two types of studies—determining, essentially, whether a certain product would more likely help an adult smoker switch to it than introduce a new generation to nicotine. Meanwhile, the FDA punted on the largest players (except for a single, outdated vape), which can still sell their products as they await a formal decision.
Should the judges in the Triton suit order the FDA to put the company’s PMTA back under review, it may well open the door for other smaller companies to follow.
Now, several of the smaller companies are suing the FDA, arguing that the agency acted in an “arbitrary and capricious manner,” shifting PMTA goalposts and not providing an adequate chance to address the changes: The need for those studies, they insist, was not clear from the onset.
In one such case, a federal court of appeals appeared to agree with the plaintiff, Triton, and granted the vape manufacturer a full stay, meaning that the company could continue selling its products pending the outcome of the lawsuit. Oral arguments for the Triton suit are set to begin on January 31.
The federal government is not known for its speed, and there are other things in flux at the agency: It’s still up in the air if President Joe Biden’s pick for commissioner, Robert Califf, will be confirmed, and Zeller has announced that he’ll retire by April. (CTP will have to install a new director.)
But should the judges in the Triton suit order the FDA to put the company’s PMTA back under review, it may well set a model for future cases. In legal terms, the agency will have failed, opening the door for other smaller companies to follow Triton’s path. If that happens, no letters will be able to change that.
Photograph by Helen Redmond
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