Home Medicine FDA appears to hold off on crackdown on synthetic nicotine products

FDA appears to hold off on crackdown on synthetic nicotine products


WASHINGTON — Congress gave the Food and Drug Administration a clear directive to crack down on vape companies skirting the agency’s rules. But there are growing signs the agency is not ready to do as instructed.

Now, advocates are apoplectic.

This March, Congress acted remarkably swiftly to give the FDA the power to regulate so-called synthetic nicotine products — vaping products, often sold in fruity flavors like ”watermelon berry,” “banana ice,” and “rainbow cloudz,” that were only on the market because of a loophole in the agency’s tobacco regulation. That loophole allowed companies to sell their products so long as they made them using nicotine produced in a lab, rather than extracting it from a tobacco plant.


Federal data show that youth have increasingly switched to these products because they still provide the fruity flavors that previously popular companies, like Juul, have discontinued. An annual survey conducted by the FDA and Centers for Disease Control and Prevention found that one synthetic vaping brand, Puff Bar, was the most popular e-cigarette among current youth tobacco users.

When Congress gave the FDA power to regulate these products, it also gave the agency clear deadlines: The law says synthetic tobacco companies had to have submitted so-called premarket applications by May 14, 2022, and that any company that didn’t submit an application by that date would be considered illegal. Congress also said that any product not authorized by the FDA as of July 13 — next Wednesday — would also be considered illegal.


But an FDA spokesperson told STAT Friday that the agency has not taken action to date against any company selling synthetic nicotine that hasn’t submitted an application.

“I am outraged,” said Matt Myers, the president of the Campaign for Tobacco-Free Kids. “If FDA allowed products to remain on the market that didn’t file an application, it is both directly contrary to the law and puts America’s kids at risk. … There is no excuse.”

The FDA also said it was “not in a position” to say how many companies selling these products actually submitted an application — making it impossible to estimate how many products are currently on the market illegally — prompting further scorn from advocates.

“It’s stunning that the FDA has not yet figured out a system by which it can count and track applications — let alone disclose the companies that are already selling products,” said Erika Sward, the assistant vice president of national advocacy at the American Lung Association. “It is stunning that the FDA after all of these years has apparently not figured out this system.”

The FDA has vocally supported the synthetic tobacco law. Officials penned an op-ed in April praising the law, writing “the critical need to clarify the FDA’s authority over these products has been met.”

STAT asked several of the largest synthetic nicotine manufacturers whether they submitted applications to the FDA. Only one company, Puff Bar, replied. The company confirmed it had submitted an application to the FDA, but declined to specify when the application was submitted or what products it covered.

It’s likely that advocates’ outrage will continue into next week. Many expected the FDA to take swift action by then to pull all products with pending applications off the market — given the law’s clear language that those products are now illegal.

Asked whether the FDA would initiate enforcement action against all companies with pending applications for synthetic products, an agency spokesperson declined to make that pledge.

Instead, the spokesperson said that products with pending applications will be “subject to enforcement action at FDA’s discretion.”

The FDA’s answer had advocates on high alert that the agency may not pull a large swath of products off the market.

There is precedent for their concern. The FDA previously blew past a court-ordered deadline for reviewing traditional tobacco-based vaping products — letting products with pending applications stay on the market for months while the agency finished its reviews.

Sward, of the American Lung Association, called the FDA comments “highly troubling” and argued that the agency was “hiding behind” enforcement discretion to not go after companies clearly violating the law.

“The Lung Association would certainly hope that given the ample time that FDA has had to handle the synthetic nicotine applications that all of these products would be removed from the market after July 13,” Sward said, adding that if FDA grants an application that product can then go back on the market.

Myers responded similarly, saying: “If FDA allows these products to stay on the market at all it will be directly contrary to the congressional mandate.”

It is possible, however, that the FDA may still take action against some companies next week, though it’s impossible to say for sure. A total lack of FDA enforcement would surprise even tobacco industry attorneys.

Azim Chowdhury, a partner at Keller and Heckman, told STAT before the FDA’s statements that he would be “shocked” if the agency didn’t take enforcement action against at least some synthetic nicotine companies after Wednesday’s deadline given the clear directive from Congress.

“You have a statute telling [the FDA] that these products are unauthorized to sell after July 13 unless they have an authorization,” Chowdhury said, adding that he expects the FDA to go after big companies known for marketing to kids, and hopes the agency does not try to put small vape shops out of business. “It’s telling the FDA that members of Congress believe they need to come after these products.”

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