FDA's Gottlieb Reaffirms Efforts to Stave Off New Youth Smokers

(Bloomberg) -- Avoiding creation of a new generation of smokers is key for the U.S. Food and Drug Administration as it decides whether to allow new tobacco products and flavors, Commissioner Scott Gottlieb said in an interview.

Philip Morris International Inc. and Altria Group Inc. are waiting to hear from the agency about whether iQos “heat-not-burn” tobacco products can be sold in the U.S. Philip Morris makes them and Altria holds the U.S. licensing agreement. A second application seeks to market them as reduced-risk compared with traditional cigarettes. As it weighs that decision, the FDA announced earlier this month it’s considering a ban on flavors, including menthol -- partly to combat the appeal of candy flavors in devices sold by companies like Juul Labs Inc.

Gottlieb outlined the agency’s approach to those decisions at Bloomberg headquarters in New York Monday that also touched on a coming crackdown on counterfeits.

“The two big things you’re looking at are the ability to migrate currently addicted adult smokers onto less harmful products, and the ability to prevent youth initiation,” Gottlieb said. The agency will give more weight to youth issues in its calculation on whether to approve iQos because Congress has specifically directed it to consider younger smokers.

Philip Morris has said its data from international rollouts of iQos in Japan, Germany and the U.K. show that 98 percent of users previously used tobacco products. Its studies also show toxicants are reduced by 90 percent to 95 percent as compared with traditional cigarettes. The FDA is reviewing data from the company and other sources on such issues, Gottlieb said.

The agency’s approach to flavor is also centered on youth because about 54 percent of kids who start using tobacco do so with menthol, he said. “Flavors are a key on-ramp both in the combustible products as well as non-combustible products.”

Timing is key and can complicate decision-making, Gottlieb said. “We didn’t want to create a marketplace where you walk into a store and the combustible tobacco products have features that make them potentially more attractive to an adult smoker or a child than the non-combustible.”

Another challenge for the agency that doesn’t get talked about a lot, he said, are fake products. Juul gadgets are heavily counterfeited, he said. “You’re going to see the FDA taking some significant steps” to target the fakes, Gottlieb said.

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