FDA plans to speed authorization of flavored vapes and nicotine pouches

Move contrasts with first-term ban on fruit-flavored vapes

The 2021 rule, proposed during President Trump’s first term and finalized under President Biden, set the scientific-evidence standards companies must meet to keep new tobacco products on the U.S. market. Vapes and nicotine pouches are not eligible for the simplified path that exists for older products like cigarettes.

One option under consideration is to simplify requirements for scientific studies and speed review times, according to one of the people familiar. The administration wants products it considers less harmful for smokers — flavored vapes among them — to reach the market more easily, the people said.

“The Trump administration is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets, and providing safer alternatives for adults who want to quit smoking cigarettes,” an HHS spokeswoman said.

Tobacco companies and some policy experts have argued that a more vibrant legal market, with more flavors available, would help displace the flood of illegal Chinese vapes they say are marketed to teens. Public-health groups counter that the flavors appeal to children and can introduce people to tobacco for the first time.

Frustrated with the slow pace of approvals, a group of manufacturers and retailers — including Altria-owned NJOY — sued the FDA earlier this month over the 2021 rule, saying the agency’s “regulatory roadblocks” had produced an “insurmountable logjam” of applications that kept new products off the market.

The shift marks a contrast from Trump’s first term, when the FDA banned fruit-flavored vapes in an effort to curb teen use. This year the agency authorized several new nicotine pouches and allowed some to be marketed as less harmful for smokers than traditional cigarettes.

In May, the FDA issued guidance allowing companies to sell most tobacco products legally after they have filed applications but before receiving a complete scientific review. Public-health groups including the Campaign for Tobacco-Free Kids sued the administration over that guidance, arguing the agency violated federal law by failing to allow public comment on the change.

Mitch Zeller, the former director of the FDA’s tobacco center who helped write the 2021 rule, said he was skeptical of the agency’s recent direction on flavored products. “The solution to the massive problem of illicit flavored vapes today is the right kind of enforcement action, not new policy that lowers the evidentiary bar to get more flavored products authorized,” he said.

Lawmakers from both parties have objected to recent FDA approvals of flavored tobacco products, including blueberry and mango. “That only makes vaping more attractive to young people,” Sen. Susan Collins (R., Maine) said at a hearing earlier this month.

Flavored vapes are expected to be a flashpoint at Thursday’s confirmation hearing for Dr. Heidi Overton, Trump’s nominee to lead the FDA. The previous commissioner, Dr. Marty Makary, clashed with the White House over flavored tobacco products before resigning under pressure.