A federal judge in Maryland, U.S. District Judge Paul Grimm, ordered the U.S. Food and Drug Administration (FDA) to advance the regulation of e-cigarettes and other deemed tobacco products. Grimm’s judgment is the latest in an ongoing case between the agency and public health groups.
The case is American Academy of Pediatrics et al. v. FDA, which I reported on for Vaping Post in May. We additionally reported last week that Grimm’s order now only gives e-cigarette manufacturers ten months to submit PMTA documentation for product approval, per the Tobacco Control Act of 2009.
The initial ruling ordered the more immediate issuance of PMTA requirements.
Specifically, Grimm’s initial decision forces the FDA to vacate a 2017 guidance delaying premarket tobacco applications (PMTA) for e-cigarette and vape products to a later date. The agency utilized its discretionary power as the enforcing agency to implement the deadline for PMTA applications and similarly allowed products that would be technically deemed as non-compliant to remain on the market during the interim. Courts typically allow enforcing agencies to determine compliance policies under the specific federal statutes. However, the public health organizations suing as the plaintiff class were able to challenge several legal precedences in this case.
“Manufacturers [are] responsible for the public harm a holiday from meeting the obligations of the law.”
Grimm wrote in his first summary judgment that the FDA’s delay on the premarket approval process allowed the “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.” Such a claim demonstrates a bias.
As of this case, no firms have submitted PMTA applications which have been accused of being costly, time-consuming, and unfair to small manufacturers and mom and pop shops.
“The record before me shows a purposeful avoidance by the industry of complying with the premarket requirements despite entreaties from the FDA that it can do so,” Grimm wrote in his most recent judgment. “The record offers little assurance that, in the absence of a deadline for filing, the industry will do anything other than raise every roadblock it can and take every available dilatory measure to keep its products on the market without approval.”
Ned Sharpless, the acting commissioner of the FDA, noted that his agency “stands ready to accelerate the review of e-cigarettes and other new tobacco products.” Cigar Aficionado notes that this will cover all deemed products, including high quality “craft” products like handmade cigars.
“This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation’s youth and especially the potential for them to become traditional cigarette smokers,” Sharpless noted in an agency commentary. “We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes.”
Former commissioner Scott Gottlieb initially issued guidance that allowed for firms to submit PMTA applications some years ahead. He changed his tune when he declared the “youth vaping epidemic” and demanded more aggressive policies on products that are scientifically proven to be safer than cigarettes.
One thing that does not sit well with this judgment and the FDA’s eagerness to accept it was how they managed to come out of the case with such a compromise — the ten-month deadline. My colleagues for another publication, Filter, noted that the agency essentially argued in defense of e-cigarettes as a potential smoking cessation aid for adult smokers.
However, I highlight this point because it seems like the agency did these things in order to save its own ass from legal insurrection. Not to mention, this was a matter of containing public reaction to a plane that recognizes that the FDA will comply with Grimm’s order to regulate e-cigarettes and deemed tobacco products.
As I noted in prior commentary related to this case, the FDA found cause to argue in defense of the industry with the industry. To be fair, the FDA was expected to make a better appeal defense to minimize the impact from the judge’s findings on the agency’s workload and ability to regulate in a timely fashion. Industry groups, on the other hand, filed amici curiae defending the FDA’s regulatory discretion.
Since the ten-month timeline is naturally a compromise, industry investment involved in defending the agency along such lines appears to be wasted. Pardon me for being so negative, but this willingness to bow to the court from the FDA is exactly what public health groups that value tobacco control over harm reduction want.
Did we travel back in time? Because it feels like Gottlieb is still in charge.