Signs of anxiety in anti-vaping camp as big decisions loom

AAmid a month of waiting for more clarity on the future of vaping in the United States, people on all sides of the tobacco harm reduction debate are growing increasingly anxious.

On January 14, a collection of nonprofit public health organizations and tobacco control groups, including the Campaign for Tobacco-Free Kids (CTFK), the American Heart Association, and the Truth Initiative, sent a letter to Mitch Zeller, 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 whom want to crack down on vaping, have urged the agency to “speed up” its decisions on which products remain on the market without approval. It had been more than four months, they noted with palpable trepidation, since the CTP had passed the court-ordered deadline for reviewing vapor companies’ premarket tobacco product applications (PMTAs) – submissions, pointed out the FDA, which would be reviewed on a case-by-case basis.

In short, they called on the FDA to “complete [the] public health review of all e-cigarettes without further ado”; “Issue marketing refusal orders [MDOs] for all non-tobacco-flavoured products, including menthol-flavoured products, on the basis of the persistent negative impact of these products on public health, and in particular their impact on youth”; “immediately prioritize law enforcement on 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 use among young people; and “identify, on an ongoing basis, products and their flavors that receive MDOs, including all menthol-flavoured products.”

The letter was hardly a surprise.

“Such groups that go off on tangents that show both ignorance and arrogance, and ignore the kind of risk-benefit analysis and human rights that should be a key part of policy-making public health, are disappointing and consistent behavior,” said industry expert David Sweanor. and chair of the advisory board of the Center for Health Law, Policy and Ethics at the University of Ottawa, said Filtered.

The problem is that with declining vaping rates among young people, the landscape is not improving for prohibitionists.

Their message has not changed: we must ban everything we can to prevent teens from accessing vapor products, even though countless experts have praised their ability to help adult smokers switch to an alternative. more sure.

The problem is that with youth vaping rates declining – and the FDA having set a kind of precedent by allowing one vaping product and not yet denying others made by larger companies – the landscape does not improve for the prohibitionists. These nonprofits decided the time was right to step up the pressure on the FDA, which is in a position to try to regulate a robust and lucrative industry that has been around for more than a decade overnight.

Sensationalized stories of the youth vaping “epidemic” have dominated the media for the past few years, but we will soon be entering new territory. By the end of January, federal judges will not be assessing the seriousness of youth vaping, but rather determining whether the FDA failed to act within the bounds of the law. The distinction is important: what is about to be at stake is the FDA process itself.

Two things are happening simultaneously: As anti-nicotine and prohibited entities pillory the FDA for ignoring a waning youth vaping “crisis”, manufacturers (along with vapers and harm reductionists) criticize the agency for not treating them fairly. The political and dominant attention for the first tends to mask the second.

To understand all this, we must recall the origins of the bureaucratic mess: manufacturers had until September 2020 to submit their PMTAs; the FDA had an additional year to decide on the applications it received.

A federal judge had set that deadline after the organizations behind the recent letter sued the FDA to move the PMTA dates; the rapidly approaching deadline meant that many small and medium-sized vape producers had to send in whatever they had. The FDA issued little to no practical guidance, and small companies huddled together to send millions and millions of rushed, sometimes half-finished, PMTAs for every product variant.

Likely seeking to reduce the amassed paperwork, the FDA then created a new “Fatal Flaw” standard that would determine whether 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 be more likely to help an adult smoker switch to it rather than introduce a new generation to nicotine. Meanwhile, the FDA has bet on the biggest players (with the exception of a single obsolete vaper), who can still sell their products pending a formal decision.

If the judges in the Triton trial order the FDA to revisit the company’s PMTA, it could well open the door for other small companies.

Now, several of the smaller companies are suing the FDA, arguing that the agency acted “arbitrarily and capriciously,” shifting the PMTA’s goals and not giving an adequate chance to address the changes: The need for these studies, they insist, was unclear from the outset.

In one such case, a federal appeals court appeared to agree with the plaintiff, Triton, and granted the vaping maker a full reprieve, meaning the company could continue to sell its products. pending the outcome of the trial. Oral arguments in the Triton lawsuit are scheduled to begin on January 31.

The federal government is not known for its speed, and there are other things going on within the agency: it remains to be seen whether President Joe Biden’s choice for commissioner, Robert Califf, will be confirmed, and Zeller announced he would retire in April. (CTP will need to install a new director.)

But if the judges in the Triton trial order the FDA to re-submit the company’s PMTA, it could well serve as a template for future cases. In legal terms, the agency will have failed, opening the door for other small businesses to follow Triton’s path. If that happens, no letter can change that.

Photography by Helen Redmond

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