US FDA may revisit evidence rules for newer tobacco products

The US Food and Drug Administration is expected to announce that it will revisit its 2021 rules on the scientific evidence needed to authorize newer tobacco products, including flavored vapes and nicotine pouches. Possible changes could make reviews simpler or faster, but they have also raised concerns about flavored products and youth access.

The Wall Street Journal’s Liz Essley Whyte and Laura Cooper reported that the FDA may reconsider the rule, citing people familiar with the matter. The rules set out what companies must submit when seeking authorization for products such as vapes and pouches. These products cannot use the simplified application route available to cigarettes.

Review timelines and competing arguments

Companies have said reviews that were expected to take about six months have instead lasted for years. Options under consideration reportedly include simplifying study requirements and speeding up reviews.

An HHS spokeswoman said the administration was committed to keeping nicotine away from children, addressing counterfeit vaping products and providing safer alternatives for adults who want to quit smoking cigarettes. Industry representatives argue that a strong legal market could displace illicit Chinese vapes. Public-health groups counter that flavors can attract young people.

The potential review would mark a shift from Trump’s first term, when the FDA banned fruit-flavored vapes. Earlier this month, a group that includes Altria-owned NJOY sued over the 2021 rule, describing applications as caught in an “insurmountable logjam.” In May, the FDA allowed most products to be sold before completing a full scientific review, prompting a lawsuit from the Campaign for Tobacco-Free Kids.

Concerns about flavored products

Mitch Zeller, a former director of the FDA’s tobacco center who helped write the rule, argued that enforcement—not lowering the evidence required for authorization—is the way to address illicit flavored vapes.

Lawmakers from both parties have objected to approvals for flavors such as blueberry and mango. Senator Susan Collins, a Republican from Maine, said such flavors make vaping more attractive to young people.

The source report said a confirmation hearing for FDA nominee Dr. Heidi Overton was expected on Thursday. Her predecessor, Dr. Marty Makary, had clashed with the White House over flavored tobacco before resigning under pressure.