FDA chief stays mum on plans for banning flavored vapes

By Virginia Langmaid, CNN

Members of Congress pressed acting US Food and Drug Administration Commissioner Dr. Janet Woodcock on Wednesday to ban all flavored e-cigarettes, saying the sweet and fruity flavors are attracting too many children and teens.

But Woodcock would not be drawn on whether the agency plans to ban or otherwise limit the sale of flavored vapes later this year.

E-cigarette makers must apply to the FDA for permission to keep their products on the US market. The agency has until September 9 to decide.

“If the FDA banned all flavored e-cigarettes, would less kids continue to vape, among those who have started, in your opinion?” Rep. Katie Porter (D-CA), asked in a House Oversight and Reform Committee hearing.

“While I can’t predict the future, I think that might be likely. We also would have to, regardless, limit advertising and sales in targeting children and other practices,” Woodcock said.

“Well, if they’re not on the market, it’s tough to advertise then, right?” Porter asked.

According to the FDA’s data on youth tobacco use, more than 80% of youth e-cigarette users consume flavored products. The FDA has been under pressure to simply ban the flavored products.

“If kids have the choices of any tasty flavor, they’re going to go for it, and I’m speaking to you from experience here as a mom of three school-aged kids,” Porter said.

“If there were no watermelon snow cones, my kids are happy with blue raspberry. No blue raspberry? They’ll take mango. No mango? They’ll take strawberry. But if their only choice was a brown, tobacco-flavored snow cone, they are going to walk away,” she said.

Pressed multiple times over the course of the hearing, Woodcock would not commit to denying the applications at this time.

Medical groups and advocacy groups such as the Campaign for Tobacco-Free Kids have been pressing hard for a ban. But e-cigarette manufacturers say their products are a safer alternative to combustible cigarettes and argue the flavors also attract adult smokers.

Woodcock said the FDA will look at the scientific evidence. “As I have said already, I can’t prejudge the scientific,” she said, before being cut off.

“Dr. Woodcock, you may not be willing to do it, but I just want to make sure America understands. You have the authority to commit today to preventing millions of kids from becoming addicted to vaping by making the decision and the commitment today to us,” Porter said.

Rep. Raja Krishnamoorthi (D-IL), chairman of the Oversight Subcommittee on Economic and Consumer Policy, said after the hearing he felt Woodcock would do as Democratic members of Congress wished.

“I am more optimistic than ever that Commissioner Woodcock will do the right thing and deny the premarket tobacco product applications (PMTA) for all flavored vaping products, and all high-nicotine vaping products,” Krishnamoorthi said in a statement.

“E-cigarette manufacturers have acted with a complete disregard for the health of young people across this country. Their actions are appalling, and the federal government can no longer allow this industry to foster youth addiction as a long-term marketing strategy for its deadly products,” House Oversight Committee Chairwoman Carolyn Maloney (D-NY) said in opening remarks.

“Our nation’s regulatory agencies must take immediate action to turn the tide on this crisis. FDA can build on the steps it’s taken so far by prohibiting the sale of remaining flavored products, capping nicotine levels in e-cigarettes, and pulling illegal products — like those sold by Puff Bar — off the market. I strongly urge the agency to take these commonsense steps.”

Woodcock would also not commit to removing menthol-flavored e-cigarette products from the US market — even though she said she believes menthol flavoring could heighten the effects of nicotine.

“I was so pleased that you banned menthol combustible cigarettes, which was the right thing to do,” Krishnamoorthi said during the hearing. “Will you pledge to clear the market of menthol e-cigarettes?”

“I can’t prejudge our decisions,” Woodcock replied.

“What I can say is that menthol has additional properties — pharmacologic properties — that I believe potentiate the effects of nicotine addiction and make it harder to stop either vaping or smoking,” Woodcock said. “It’s, to my mind, like actually having a higher concentration of nicotine in whatever delivery system.”

In a news release from April following the FDA’s ban on menthol products in combustible cigarettes, the agency said evidence indicated menthol “increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults.”

“That is my belief based on the data,” Woodcock said in Wednesday’s hearing. “I don’t think it’s totally settled, but evidence shows it’s harder for people who smoke menthol cigarettes to stop smoking.”

Plus, the new products make it harder to treat nicotine addiction, Woodcock said. She said doctors and other health care providers may not know how to help kids addicted to nicotine through vaping and other alternatives to combustible cigarettes.

“I really think we are going to have to focus on recovery for teens to get them off their nicotine addiction. I don’t know that the health care community is well aware of how it might work for youth who are addicted to nicotine but not to cigarettes,” Woodcock said.

“We have a group of kids who are now addicted to nicotine, that we probably need to think about ways, how can we assist them in recovery, getting off of nicotine,” she added.

“There’s evidence that early exposure to various addictive products or drugs will act on the brain in ways that may make it more difficult for these individuals to stop those behaviors.”