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Tobacco-Free Vape Makers Face First FDA Enforcement Moves (1)

July 14, 2022, 2:31 PMUpdated: July 14, 2022, 7:23 PM

The FDA said it’s issued warnings to more than 100 retailers for illegally selling synthetic nicotine products to underage Americans, marking its first enforcement steps in an area that has long gone without federal oversight.

The Food and Drug Administration announced late Wednesday that it sent 107 warning letters to convenience stores and tobacco shops across the country for selling non-tobacco nicotine products, including some e-cigarettes, to customers under 21. Two synthetic nicotine makers—AZ Swagg Sauce LLC and Electric Smoke Vapor House—also got warning letters for not submitting pre-market applications for a combined total of 10,000 products by a May 14 deadline.

The steps signal the approach the agency will take on products from companies like Puff Bar that have become increasingly popular among youth. After Wednesday, any new non-tobacco nicotine product that hasn’t received premarket authorization from FDA will be considered illegal and subject to enforcement action, the agency said.

Vaping industry and consumer advocates said the FDA didn’t give companies adequate time to complete applications and that the agency is bowing to political pressure to crack down on the tobacco industry. Anti-tobacco groups say the actions don’t go far enough in making sure the products most popular among youth are quickly removed from the market.

A government spending package for fiscal 2022 gave the FDA the authority to regulate synthetic nicotine, closing a loophole that some companies had used to skirt federal oversight. Under the law, companies had until May 14 to apply, and all existing products that haven’t won authorization must be off the market as of Wednesday.

“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, the newly appointed director of the FDA’s Center for Tobacco Products.

A total of 200 manufacturers submitted roughly one million synthetic nicotine product applications by the May 14 deadline, the FDA said Wednesday. The agency said it’s preparing to issue “refuse-to-accept” letters soon for applications that don’t have the necessary components and don’t meet the criteria for FDA review.

“In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate,” King said.

The FDA didn’t give a specific timeline for its non-tobacco derived nicotine application review, but King said the agency is “working diligently” to process them and “will make marketing decisions based on the best available science” and “pursue compliance and enforcement actions when warranted.”

Synthetic nicotine use among youth has risen in recent years, due in part to many featuring fruit and candy flavors that the FDA had previously banned in tobacco-based e-cigarettes. Among middle and high school tobacco users, roughly 39% reported using e-cigarettes in 2021, and Puff Bar was the most commonly reported brand at nearly 27%, according to an annual survey from the Centers for Disease Control and Prevention.

The two manufacturers sent warning letters Wednesday didn’t immediately respond to requests for comment.

Industry, Consumer Pushback

Vaping industry members framed the FDA’s actions this week as another step in a regulatory approach that they argue is unfair and targeted.

“This latest crackdown shows that the FDA would rather pander to politicians who believe they know better than the millions of Americans who will now be forced back to cigarettes as more and more vaping products are banned,” American Vapor Manufacturers President Amanda Wheeler said in an emailed statement.

Industry and consumer groups have argued that e-cigarettes are less harmful alternatives for adult smokers looking to quit combustible cigarettes. The FDA considers in its e-cigarette reviews whether a product’s benefit to adult smokers outweighs the risk of new smoking initiation, especially among youth.

Alex Clark, CEO of the Consumer Advocates for Smoke-free Alternatives Association, said in an email that “the impossible application deadline for synthetic nicotine products was never intended to ensure that consumers are protected.”

“Removing these products will do very little to decrease demand among curious youth and will certainly make it more difficult for people to quit smoking,” he argued.

‘Minimal Action’

Anti-tobacco advocacy groups say the FDA isn’t complying with the deadlines set by Congress because the majority of synthetic nicotine products remain on the market.

“Every one of these synthetic nicotine products is now illegal, and by law, it is now illegal to sell them,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in an emailed statement. “The FDA should act immediately to remove these products from the market while reviewing the applications.”

The agency is “taking only minimal action to enforce a law the FDA itself sought from Congress,” Myers said.

“FDA’s failure to meet another deadline has real world implications for our nation’s public health and especially the health of our nation’s youth,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. She added that the lack of action on Puff Bar “is particularly troubling.”

Lawmakers have long called for the FDA to act swiftly on synthetic nicotine products. Senate Majority Whip Dick Durbin (D-Ill.) and Sen. Susan Collins (R-Maine) sent a letter to the FDA Tuesday instructing it to “clear the market of all unauthorized e-cigarettes that use synthetic nicotine” by July 13.

“Congress took swift bipartisan action to provide FDA with the tools needed to properly regulate synthetic nicotine,” they wrote. “We find it deeply disappointing and unacceptable that FDA appears to be on the brink of failing yet again at protecting our nation’s children from the dangers of nicotine addiction.”

(Updated with additional reporting throughout.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com