FDA sends warning letters on synthetic nicotine, missing deadline for more severe action

By Jen Christensen, CNN

Wednesday was the deadline for the US Food and Drug Administration’s Center for Tobacco Products to take action on popular synthetic nicotine products, but the agency stopped short of the drastic moves demanded by lawmakers and anti-tobacco advocates.

Synthetic nicotine is the industry’s attempt to sidestep FDA oversight with lab-made nicotine, which doesn’t come from tobacco and thus wasn’t considered within the agency’s purview. But the national spending package enacted in March “makes clear that FDA can regulate tobacco products containing nicotine from any source,” the agency said in April, just before the law took effect.

Companies had until May 14 to submit a premarket application to keep their products on the market. Those that did not win the FDA’s authorization of e-cigarettes that used synthetic nicotine would need to be pulled by July 13.

On Wednesday, the FDA announced what it called “its first two warning letters” to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorizations.

The letters went to AZ Swagg Sauce LLC and Electric Smoke Vapor House, which have a combined 10,000 products, according to the FDA. Neither company submitted a premarket application by the deadline, the agency said.

Under the law, anyone who makes or sells “non-tobacco nicotine” must comply with FDA regulations, which also include not selling to people under 21, not giving away samples and not making claims that their products are less harmful than cigarettes without FDA authorization.

The FDA said Wednesday that it also sent 107 warning letters to retailers in the past two weeks for illegally selling synthetic nicotine products to underage buyers.

“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, director of the Center for Tobacco Products. “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.”

After Wednesday, any new synthetic nicotine product without premarket authorization from the FDA cannot be legally marketed. The FDA says it is processing 1 million applications for synthetic nicotine products submitted by more than 200 makers.

Anti-tobacco advocates say the FDA’s action is not enough.

“It’s not even a step forward. It’s them lifting their foot,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Taking action against the retailers does not cut the beast off at the head. They need to cut the beast off at the head and deal with the manufacturers and order the products off the market.

“All products are supposed to be ordered off the market [Thursday], and there’s no excuse for any of them to remain,” Sward said.

The FDA didn’t address the most popular player on the market, Puff Bar, a disposable brand that comes in a variety of flavors including mango, strawberry banana and peach ice. The product was the most popular among students in 2021, with more than a quarter of kids in high school who currently vaped saying Puff Bar was their usual brand.

“This deadline was significant because it involves the product most popular and the brand most popular among kids, and that’s Puff Bar,” Sward said. “If FDA is going to really act to protect kids, Puff Bar needs to be the place it starts. We were fully expecting and hoping to see Puff Bar off the market, and I think that was pretty clear that was what Congress wanted.”

Puff Bar did not respond to a request for comment.

Sens. Susan Collins, R-Maine, and Dick Durbin, D-Illinois, sent a letter to the FDA to urge it to meet its deadline, and Durbin criticized the agency from the Senate floor on Wednesday.

“The FDA is supposed to protect all Americans, and particularly our children. I’m calling on FDA to finally come to its senses. Err on the side of public safety, on the side of kids, not tobacco companies. This free fall in the legal department at the FDA is unimaginable. It’s not safe for America. And it’s not safe for our future,” he said.

Anti-tobacco groups have voiced their frustration with the FDA for its inaction on this and other issues.

“In March, Congress gave clear deadlines to FDA when it passed a law requiring FDA to regulate tobacco products made with synthetic nicotine,” said American Lung Association President and CEO Harold Wimmer. “The FDA has the tools it needs and now must act to immediately remove these products from the market as Congress required.”

In May, the FDA announced that it would not finish reviewing all the premarket applications from e-cigarette companies until June 2023, nearly two years past its court-ordered deadline to make a decision about those products.

More than 2 million middle and high school students used e-cigarettes in 2021, according to the National Youth Tobacco Survey.

“The continued delay by the FDA puts more kids at risk of becoming addicted to these products. We urge FDA to swiftly remove all synthetic nicotine products from the market and put strict enforcement measures in place,” Wimmer said.

Last week, the FDA announced a stay of its order to remove all of Juul Labs’ vaping products from store shelves, after a US appeals court entered a temporary administrative stay June 24. The agency cited “scientific issues” and said they warranted additional review. Anti-tobacco groups accused the agency of sending mixed signals.

The Biden administration has made some moves to discourage smoking. In June, it signaled that it will develop a proposed rule to establish a maximum nicotine level in cigarettes and other tobacco products.

The FDA also proposed a rule to ban menthol cigarettes and flavored cigars in April. It held listening sessions on the topic this summer, and the agency is reviewing the comments before a rule becomes finalized. However, tobacco companies are expected sue to keep the rule from going into effect.

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CNN’s Michael Nedelman contributed to this report.