Judge orders FDA to begin approval process for vaping devices immediately
On Wednesday, a federal judge ruled that the U.S. Food and Drug Administration (FDA) acted illegally by delaying self-established deadlines included within their deeming regulations of May 2016. Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered the FDA to take immediate actions to initiate the Pre-Market Tobacco Applications (PMTA) process on all vaping and tobacco products. The ruling is likely to be appealed, but it is nonetheless a significant blow to the American vaping industry.
According to the FDA deeming regulations released in May of 2016, PMTAs were to be submitted by manufacturers of vapor products initially released to market prior to the predicate date of February 15, 2007. The original deadline for submittal was one month later in August, but the FDA seems to have failed to consider just how massive an undertaking that would be.
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By May 2016, thousands of vapor products were already on the market, not to mention the unquantifiable number of applicable cigars, hookahs, and other tobacco products referenced in the new deeming regulations. The FDA almost immediately began to realize that the nations premier public health agency had a big, big problem. It lacks the necessary internal infrastructure required to accept, track, verify, and review the “data derived from nonclinical laboratory and clinical studies” necessary for eventual approval or denial of so many applications in a timely manner.
In July of 2017, an FDA News Release announced a nearly five-year extension for the submission of PMTA applications on non-combustible tobacco products like e-cigs and vaping devices. Vape vendors would now have until August 2022, and retailers of more conventional combustible products like cigars and hookahs would receive a similar extension of August 2021.
Judge Grimm blasts both the FDA and the American vaping industry
In his ruling document (Case No.: PWG-18-883), Judge Grimm reprimands the FDA for rolling out such obviously controversial regulatory requirements in such an unconventional and poorly planned manner. He also essentially outright accuses the American vaping industry of taking advantage of the five-year extension by intentionally kicking up their underage marketing tactics to increase future sales.
“Instead of addressing public health concerns associated with tobacco use by minors and others, the August 2017 Guidance exacerbates the situation by stating, in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market, like the “Apple Juice” e-cigarette discussed in Plaintiffs’ Complaint, at a time when minors’ use of tobacco products like e-cigarettes is at an epidemic level and rising.”
“Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that already are approved— results entirely contrary to the express purpose of the Tobacco Control Act. The publication of the August 2017 Guidance clearly was contrary to the Tobacco Control Act’s purpose and therefore an ultra vires action through which the FDA ‘exceeded the authority granted to it by Congress, and its . . . action cannot stand.’”
The judge is clearing ruling in favor of anti-vaping groups like the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics, two of the more notorious such organizations which often intentionally muddle the true definitions of tobacco and nicotine.
This practice of deliberately obscuring of the facts about vaping is also apparent in the wording of the FDA deeming regulations themselves which now legally classify electronic cigarettes as “tobacco products” even though they are 100 percent tobacco-free. The judge’s ruling is a significant setback for vaping, to be sure, but the War to Save Vaping continues.
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