WASHINGTON — The FDA should be doing more to stop kids from getting addicted to e-cigarettes, House members told FDA Acting Commissioner Janet Woodcock, MD, at a hearing on youth vaping on Wednesday.

“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,” Rep. Katie Porter (D-Calif.) said at the House Oversight and Reform Subcommittee on Economic and Consumer Policy hearing. “And if you don’t make that decision today, in this oversight hearing, then the alternative is going to be years and years of delay, while Congress tries to pass a bill, and millions more kids getting addicted … I hear you — you’re not willing to make that commitment to youth today, but I do want the American people to understand, you do have that power.”

Problem in Middle School and High School

Subcommittee chairman Raja Krishnamoorthi (D-Ill.) began the hearing by laying out statistics on the problem. “Today, more than 20% of high schoolers vape, and 5% of middle schoolers vape,” he said. “Those are the same levels that compelled the Surgeon General to first declare a youth vaping epidemic 3 years ago, in 2018. For as long as this subcommittee has existed, we have been investigating this epidemic. This is our fourth hearing on the matter, and I sincerely hope it’s our last, because the problems are solvable.”

Krishnamoorthi focused some of his questions on flavored e-cigarettes, noting that the agency’s 2020 e-cigarette “flavor ban” included two exemptions: one for tobacco and menthol flavors for Juul and other cartridge-based devices, and another for all flavors of disposable e-cigarettes. He said that while 44% of youth vapers used mint Juul e-cigarettes, “and when mint was banned in February 2020 … Guess what — 44.5% of youth [now] use menthol Juuls.” He asked Woodcock whether she would pledge to clear the market of menthol e-cigarettes. She said she couldn’t “prejudge” what the agency would do but added, “What I can say is that menthol has additional properties and pharmacologic properties that I believe potentiate the effects of nicotine addiction, and make it harder to stop either vaping, or smoking.”

Rep. Hank Johnson (D-Ga.) zeroed in on the 6 million Pre-Market Tobacco Applications (PMTAs) that e-cigarette makers and vape shops have submitted in order to market their products. “A significant number of those PMTA’s were submitted by vape shops, which are required to submit a PMTA for every flavor that they mix,” Johnson said. “This means that a single small vape shop might have applications for, say, 30,000 products,” so those applications make up most of the 6 million, he explained. But looking at the application list in terms of which applicants are responsible for the biggest share of the youth vaping market, “the list goes down to about 44 companies, which is a much more manageable number,” he said.

“Commissioner, the FDA is under court order to finish ruling on applications by Sept. 9, 2021, but has signaled that it will likely miss that deadline,” Johnson said. “Can you commit today to ruling on all of those applications from the 44 companies that create products that children are most likely to use by that September 9 deadline?”

“I cannot commit; I have to see the list,” Woodcock said. “I will tell you we have prioritized market share, so that we have made sure that we’re looking at companies with some large market share that would have the most impact … I think there are only about five companies that have the vast majority of the market share.” She said she couldn’t name them but would get back to the committee with that information. “I will commit to do everything I can to make sure that we have reviewed and finished all the high-market-share company applications, because that will have the most impact on this problem we’re mutually facing,” she added.

Use of “Enforcement Discretion”

“The possibility that a company like Puff Bar might gain months of profit off children because of a backlog at the FDA is troubling and unacceptable,” Johnson said. “If you fail to rule on all PMTA’s from the five companies, and the 44 companies with pod and disposable applications that the committee has identified by the September deadline, will you commit to pulling those products from the market until the applications have been reviewed?”

Woodcock seemed agreeable but declined to commit, saying that those products were currently only being marketed under “enforcement discretion” — that is, the FDA was allowing them on the market even though they haven’t officially been approved — and would be subject to enforcement discretion again after the September deadline has passed, meaning the agency could enforce the rules against those companies and make them drop those products at any time.

Rep. James Comer (R-Ky.), ranking member of the full Oversight and Reform Committee, was concerned about illegal e-cigarette products containing vitamin E acetate, which is found mostly in THC. “What steps has FDA taken to crack down on these illicit market e-cigarettes, and are imports from other countries like China playing a role?” Woodcock said they were.

“We certainly work with Customs and Border Patrol; we have seized fraudulent products coming from China, among other places,” she said. “We make every attempt to keep these from crossing our border. We also send warning letters — many to companies who failed to submit applications. They then submit an application in response to that warning letter.” Krishnamoorthi picked up on the warning letter comment. “There’s a perception that too many warning letters are sent and not enough enforcement action is taken, so that’s something that I hope that we will take under advisement,” he said.

Higher Nicotine Content in the U.S.

Rep. Debbie Wasserman Schultz (D-Fla.), who is not a subcommittee member but was permitted to participate, noted that the European Union, the U.K., and Israel all cap the amount of nicotine allowed in e-cigarettes to 20 mg/mL, while in the U.S., where there is no limit, Juul is selling e-cigarettes with 59 mg/mL. “Would you agree that these countries have helped reduce youth e-cigarette use by capping nicotine levels?” “It appears that way,” Woodcock replied.

“In the U.K., 94% of kids have never vaped and only 1.8% of youth are using e-cigarettes more than weekly. Because of the lower nicotine levels, even Juul isn’t popular with kids in the U.K.,” Wasserman Schultz said. “Would fewer kids become addicted to e-cigarettes if there were no e-cigarettes in the U.S. over 20 mg/mL of nicotine?” “Yes,” Woodcock said. Wasserman Schultz asked her whether she would consider lowering the allowable level of nicotine. Woodcock demurred, saying she couldn’t comment on what action the agency might take, although she did say the FDA was looking at the levels of nicotine for the products included in the PMTA applications.

Wasserman Schultz also addressed the issue of whether e-cigarettes were often used to help people quit smoking regular tobacco cigarettes. “Over half of 18-to-24-year-olds who vape never smoked cigarettes,” she said. “Vaping introduced and hooked them on nicotine. That’s evidence of the products as an on-ramp, not an off-ramp to nicotine use, isn’t it?” she asked. “Yes,” Woodcock agreed. Wasserman added that while 41% of youth vapers say Juul is their preferred brand, only 5.6% of adults say the same, adding more evidence to the theory that Juul’s high-nicotine products are not helping many adult smokers to quit.