When the FDA deeming regulations were first announced on May 5, 2016, Nicopure Labs was the first to file a lawsuit arguing the legality of the new requirements. The controversy involves several factors, perhaps the most important of which is the new regulation for all e-liquid manufacturers to undergo a Pre-Market Tobacco Applications process (PMTA). This is the same approval process used by Big Tobacco products, such as conventional cigarettes, pipe tobacco, and chewing tobacco. The PMTA could also cost in upwards of $1 million per product and essentially wipe out the entire American vaping industry within the next two years.
Several other companies followed the lead of Nicopure Labs. Eventually, so many similar lawsuits were filed against the FDA that Judge Amy Berman Jackson was forced to combine eleven of them into one consolidated lawsuit. On August 16, 2016, the FDA released a 101-page response to the many combined allegations. Just four days ago on September 9, 2016, the agency issued another. In both cases, the tone of the document might be considered a bit arrogant if not condescending. It will be interesting to see what effect this latest response plays in the final ruling. Below is a portion of the official document for Case 1:16-cv-00878-ABJ.
I. E-CIGARETTES—AND THEIR COMPONENTS AND PARTS—ARE PROPERLY REGULATED UNDER THE TOBACCO CONTROL ACT
II. THE FDA’S DEEMING AUTHORITY IS COMMITTED TO AGENCY DISCRETION, AND THE AGENCY’S EXERCISE OF THAT AUTHORITY WAS IN ANY EVENT REASONABLE
III. THERE IS NO BASIS TO SECOND-GUESS THE FDA’S DETERMINATION THAT THE BENEFITS OF THE DEEMING RULE JUSTIFY ITS COSTS
IV. THE FDA FULLY COMPLIED WITH THE REGULATORY FLEXIBILITY ACT
V. THE DEEMING RULE IS CONSISTENT WITH THE FIRST AMENDMENT
Plaintiffs do not deny the many health risks of e-cigarettes—from nicotine addiction, to the inhalation of toxins and carcinogens, to the risk of explosion. Nor do they dispute that e- cigarette use has skyrocketed, particularly among youth. Nevertheless, while they may claim not to oppose “all” regulation of e-cigarettes, that is the obvious consequence of many of their arguments.
Plaintiffs’ rendering of the Tobacco Control Act (“TCA”) bears no relation to its text. Their reading of “tobacco product” to exclude open-system e-cigarettes writes the phrase “any component, part, or accessory” out of the statute. They think it irrelevant that the statute permits the FDA to subject tobacco products to the TCA as the agency “deems” fit. They seek APA review of a cost-benefit analysis that the statute does not require—and then not only cook the books, but ask the Court to examine only one side of the ledger. And they urge the Court to simply delete the statutory premarket review requirement—or at least to amend the grandfather date set by Congress—which would exempt as many as 800 e-cigarette devices and 8,000 e- liquids from premarket review entirely.
This is not the statute that Congress wrote. More than enough is already known about the health risks of e-cigarettes to warrant regulatory oversight. And Congress’s choice to ban free sampling and to require premarket review of “modified risk” products is fully consistent with binding precedent, and would in any event survive First Amendment scrutiny. Those provisions are reasonably tailored to protect the public—especially youth—from the harms of addictive products. The Court should not require the FDA to turn a blind eye to those risks.
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Plaintiffs also argue that the addictive nature of their products is irrelevant because they have an interest in “communicating information” about “legal” products. But the addictive nature of e-cigarettes underscores the importance of verifying at the outset that they present a modified risk, rather than waiting until potentially misled consumers are thoroughly addicted to them. Premarket review protects those who would find it hard to stop using an addictive product upon learning that they were misled, and is thus an effective and narrowly tailored means of promoting government interests.
(Related Article: NICOPURE MAKES HISTORY; FILES FIRST LAWSUIT OVER FDA E-CIG REGULATIONS)
(Related Article: FDA RESPONDS TO NICOPURE LABS AND R2B SMOKE-FREE LAWSUITS)