In 2016, the Food & Drug Administration (FDA) deemed electronic cigarettes and other vaping products to be "tobacco" products for the purposes of federal law. This move gave the FDA's Center for Tobacco Products legal authority to regulate vaping products like combustible cigarettes. How the FDA has proceeded to regulate such products since, however, has been something of a mess, suggesting either some degree of administrative incompetence, malice against portions of the industry, if not both.
Last October, the U.S. Court of Appeals for the Fifth Circuit eviscerated the FDA for flouting the basic administrative law requirements of "reasoned decisionmaking" when it denied Triton Distribution's premarket tobacco applications (PMTAs) for a range of vaping products. This is a big deal because vaping companies cannot sell their products if their PMTAs are denied.
In November, the U.S. Court of Appeals for the Sixth Circuit also found fault with the FDA's attention to basic administrative law requirements, this time in the agency's review of PMTAs from Breeze Smoke, another vaping product company. While the Sixth Circuit did not grant Breeze Smoke the relief it wanted, it was critical of the FDA's "formulaic" review of the PMTA materials.
Turning Point Brands is another vaping company that challenged the FDA's denial of its PMTAs, but rather than try its hand in court, the FDA rescinded the PMTA denial because it "found relevant information that was not adequately assessed." Oops.
With this background, it should be understandable why many industry observers raised an eyebrow when the FDA denied PMTAs from Juul Labs, one of the larger and better resourced vaping companies. If any company was capable of submitting a vape product PMTA that meets the FDA's standards, one would think it would have been Juul.
Facing the prospect of a regulatory death-sentence, Juul challenged the FDA's decision, filing a petition for review with the U.S. Court of Appeals for the D.C. Circuit and an application for an emergency stay. Among other things, Juul pointed out that some of the FDA's reasons for denying the PMTAs, such as a lack of certain sorts of information, were simply wrong. In other words, the FDA gave Juul's applications the same sort of sloppy and arbitrary treatment it had given to those of Triton, Breeze Smoke, and Turning Point. In Juul's case, some also suspected the FDA was bowing to political pressure to target Juul.
The D.C. Circuit granted Juul's request, putting the effect of the PMTA denial on hold so the court could review Juul's claims. Perhaps recognizing that the D.C. Circuit would find the its conduct wanting, the FDA retreated, issuing an administrative stay of the PMTA denial so that it could conduct additional review of Juul's application materials. As the FDA tweeted that "The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review."
On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review. (1/3) https://t.co/DHDsFNVe1l
— FDA Tobacco (@FDATobacco) July 5, 2022
Faced with the prospect of having to defend its conduct in court, the FDA decided it should take the time to conduct the review it was legally required to undertake in the first place.
As the above should make clear, the FDA's shoddy treatment of Juul is not an aberration. The Agency has time and again flouted basic administrative law requirements in denying PMTAs from vaping companies.
Some may claim that the FDA is merely trying to be careful, due to concerns that vaping products pose risks of nicotine addiction and may encourage some to take up smoking. The reality, however, is that vaping products are far-less dangerous than combustible cigarettes, providing consumers with a safer way to consume nicotine and giving smokers a more effective means of quitting (although FDA regulations bar vaping companies from informing consumers of these facts). Moreover, there is growing evidence that restrictions on vaping products can actually increase smoking, particularly among youth. In other words, the FDA's treatment of vaping products is bad for public health.
The FDA's decision to backtrack on Juul under fire is merely the latest example that something is wrong with the way the Center for Tobacco Products is seeking to regulate vaping products. Unless the FDA changes its ways, its legal losses will mount. And in the meantime, public health will suffer.
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