FDA Targets Unauthorized Vapes With Lawsuit Threats, Destruction Orders

On September 6, Brian King, the relatively new director of the Food and Drug Administration’s Center for Tobacco Products (CTP), would not say in an interview with Politico whether the agency was willing to take unauthorized vaping products off the market. It was the first time that King had granted a media interview since beginning the role in early July. Though everybody was eager to hear what he’d divulge, they all likely ended up disappointed. He said that he was “committing to explore all viable pathways that are legally and scientifically defensible,” adding that “nothing is off the table.” He did not acknowledge anything about the commission of external experts looking into CTP procedures. And he offered no specifics about any upcoming FDA enforcement, much to the chagrin of public health groups like the Michael Bloomberg-funded Campaign for Tobacco-Free Kids (CTFK) and legislators like Senator Dick Durbin.

It turns out, though, the agency had already started to take action.

The feds are seeking court orders, threatening lawsuits and demanding the destruction of unauthorized products.

Filter has confirmed that the FDA, by September 1, advised the Department of Justice (DOJ) that at least two open-system vape companies were in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because the manufacturers did not file premarket tobacco product applications (PMTAs) and were continuing to sell their products. According to a letter to one of the vape companies, viewed by Filter, the feds are seeking court orders, threatening lawsuits and demanding the destruction of unauthorized products.

All vapor manufacturers had until September 2020 to file PMTAs. These had to show through extensive and costly studies, which many companies have said they only learned about after the deadline, that their products were more likely to transition adult smokers to their safer nicotine alternatives than introduce a new generation to nicotine. CTP has denied around 99 percent of these applications so far, and dozens of companies have sued over their denials, which they have largely argued were “arbitrary” and “capricious.”

“We plan to seek a court order to permanently enjoin you … from, among other things, directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product at or from any of your facilities, unless and until, among other things, the product receives, and has in effect, marketing authorization from FDA,” reads the letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and dated September 1. “The enclosed proposed consent decree,” it continues, “states the terms upon which the government would be willing to settle the suit that we plan to file.”

Filter agreed not to disclose the names of the individuals and companies that received the letters (one of the companies has now ceased business operations) because of the possibility that litigation could unfold. An FDA spokesperson told Filter that the agency “declines to comment on ongoing investigations.”

“Defendants shall bear the costs of destruction and the costs of FDA’s supervision.”

One industry insider, who requested anonymity so as not to affect his company’s PMTA process, said that the letter was “a clear escalation”—the first time, to his knowledge, that the FDA had gone beyond warnings and explicitly threatened to sue over sales of unauthorized nicotine vapes. (Both companies had received warning letters in the past.) Some manufacturers did not even bother to file PMTAs because of the associated labor and cost—and the knowledge that the FDA would probably just deny them anyway.

“Their exercise of enforcement discretion to date has reached almost legendary proportions, so this would be at least a small deviation from that,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the American Cancer Society’s former vice president for tobacco control, told Filter. “My sense is that there are many, many instances of such behavior across the country, which Mitch Zeller and others have referred to as requiring FDA to play whack-a-mole, so a big question would appear to be whether this signals a new direction or is a random example of enforcement action.”

The two companies known to have received letters, at least, have been ordered to physically destroy their own products, under FDA supervision.

“Within thirty (30) days after entry of this Decree, Defendants shall, under FDA’s supervision and pursuant to a written destruction plan approved in writing by FDA prior to implementation, destroy all Defendants’ ENDS products in their custody, control, or possession as of the date this Decree is signed by the parties,” the letter reads. “Defendants shall bear the costs of destruction and the costs of FDA’s supervision incurred under this paragraph.”

The financial penalties for ignoring the injunction would, naturally, be severe.

“If any Defendant fails to comply with any provision of this Decree, the Act, or its implementing regulations, including any time frame imposed by this Decree, then Defendants shall pay the United States of America: five thousand dollars ($5,000) in liquidated damages for each day such violation continues; an additional sum of four thousand dollars ($4,000) in liquidated damages per day per violation, for each violation of this Decree, the Act, or its implementing regulations; and an additional sum in liquidated damages equal to twice the retail value of any product distributed in violation of this Decree, the Act, or its implementing regulations,” the letter reads.

“It is just beyond outrageous that the FDA is now conscripting the Department of Justice in its misbegotten war on vaping.”

If the FDA were to take this all a step further, it could target the many manufacturers that have received PMTA denials and are continuing to sell their products anyway, especially if the agency keeps succumbing to what many observers have noted is misplaced political pressure.

Critics and the independent vapor industry have also repeatedly pointed out that smaller- and medium-sized manufacturers, particularly of open-system products, have not contributed to the past upticks in (and general panic around) youth vaping—and that the FDA has yet to pay similar attention to unauthorized disposables, many made in China, which have flooded the market and become the most popular vapes among teenagers. 

“It is just beyond outrageous that the FDA is now conscripting the Department of Justice in its misbegotten war on vaping,” Amanda Wheeler, a vape shop owner in Arizona and the president of American Vapor Manufacturers (AVM), told Filter. “We are talking about hard-working small businesses that are helping ordinary Americans to quit smoking, and they are now facing jaw-dropping threats from federal law enforcement agents.”

Update, September 14: This article was edited to include comment from the FDA.

Update, September 13: This article was edited to included comment from Cliff Douglas received after publication.

Photograph by Aaron Hall via Flickr/Creative Commons 2.0