Subcommittee Hearing Offers Insight into Future of E-Cigarette Regulation

Jun 23, 2021
Press Release
FDA Commissioner Appears Dedicated to Ending the Youth Vaping Epidemic

Washington D.C. (June 23, 2021)— Today, Congressman Raja Krishnamoorthi, Chairman of the Oversight Subcommittee on Economic and Consumer Policy, held a hearing on “An Epidemic Continues:  Youth Vaping in America.”

 

“Today, the Acting Commissioner of the FDA agreed that flavored e-cigarettes are dangerous to the public health because they attract kids, and that if any flavors are left on the market, kids will flock to them,” said Subcommittee Chairman Krishnamoorthi.  “She said that menthol makes e-cigarettes more addictive.  She said that high-nicotine e-cigarettes are dangerous because they lead to youth addiction.  And she said that JUUL is responsible for the youth vaping epidemic.  In short, she agrees with what I have been telling FDA for years.  I am more optimistic than ever that Commissioner Woodcock will do the right thing and deny the PMTA applications for all flavored vaping products, and all high-nicotine vaping products.”

 

At today’s hearing, the Subcommittee heard testimony from Senator Richard Durbin and the Food and Drug Administration’s (FDA) Acting Commissioner Dr. Janet Woodcock.

 

Commissioner Woodcock agreed with Members that JUUL is a “public health problem of significance,” and that menthol e-cigarettes and flavored e-cigarettes pose significant dangers to children.

 

  • When asked by Congressman Mark DeSaulnier if JUUL, “a nicotine product used by 41% of youth vapers is hurting the overall public health for generations to come,” Commissioner Woodcock replied “It’s hurting that generation,” and “it’s definitely a public health problem of significance.”

 

  • Commissioner Woodcock stated that menthol in e-cigarettes is “like having a higher concentration of nicotine in your delivery system,” that “menthol heightens the addictiveness of nicotine in e-cigarettes,” and that menthol “makes it harder to stop vaping.”
  • Commissioner Woodcock agreed that “any flavor of e-cigarette left on the market is likely to encourage youth to start vaping” and that “if FDA banned all flavored e-cigarettes, less kids would continue to vape.”

 

Commissioner Woodcock acknowledged that FDA’s 2020 partial flavor ban was fundamentally flawed.

 

  • Commissioner Woodcock acknowledged that wide exemptions (for menthol and disposable e-cigarettes) in FDA’s 2020 partial flavor ban made it a “fundamentally flawed policy,” stating that the flawed policy had “very negative consequences.” 

 

  • Commissioner Woodcock stated that even after the ban, “there were certainly continued youth using of these products at really unacceptable levels.”

 

Commissioner Woodcock and Members discussed the ways in which high nicotine products are dangerous.

 

  • Commissioner Woodcock recognized that other countries “have helped reduce youth e-cigarette use by capping nicotine levels” at 20 mg/mL.  For comparison, that’s one-third the amount in a JUUL:  59 mg/mL.

 

  • Commissioner Woodcock agreed that “fewer kids would become addicted to e-cigarettes if there were no e-cigarettes in the U.S. with over 20 mg/mL of nicotine.”

 

  • Commissioner Woodcock acknowledged that the fact that “over half of 18 to 24-year olds who vape, never smoked cigarettes,”…“is evidence of the products as an on-ramp, not an off-ramp to nicotine use.”

 

Commissioner Woodcock offered new insights on the premarket tobacco product applications (PMTA) process, including that past bad acts will count against e-cigarette makers in considering their PMTA applications.

 

  • When asked by Congresswoman Jackie Speier, “if there are bad actors who have previously shown that their conduct is violative or is thumbing its nose to the government regulation, will that be taken into account in their application,” Commissioner Woodcock answered affirmatively, stating that “It will definitely be taken into account.”

 

  • Commissioner Woodcock stated that the agency is prioritizing review of the five vaping companies with the highest market share. 

 

  • Commissioner Woodcock signaled that any product whose PMTA application FDA does not rule on by its September deadline will be subject to enforcement action.  She stated that those products are “only on the market under enforcement discretion by the FDA,” and subject to enforcement action.

 

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117th Congress