Chairman Krishnamoorthi Rebukes FDA for Failure to Meet E-Cigarette Review Deadline

Sep 10, 2021
Press Release

Washington, D.C. (September 10, 2021)— Today, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter to Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock expressing deep concern about FDA’s failure to meet its September 9, 2021, deadline to rule on whether e-cigarettes can stay on the market.  

 

“Every day that FDA delays is another opportunity for a child to pick up a menthol JUUL and start on a path to addiction.  In your words, ‘any flavor of e-cigarette left on the market is likely to encourage youth to start vaping.’  If you are going to ignore your deadlines, we need an explanation,” Chairman Krishnamoorthi wrote to Acting FDA Commissioner Woodcock.

 

FDA’s failure to meet its deadline is particularly troubling because the agency failed to rule on any Premarket Tobacco Product Applications (PMTAs) from companies with significant market share, despite previous commitments from Acting Commissioner Woodcock to prioritize this effort. 

 

On June 23, 2021, the Subcommittee on Economic and Consumer Policy held a hearing entitled “An Epidemic Continues:  Youth Vaping in America.” 

 

At the hearing, Acting Commissioner Woodcock testified that FDA had prioritized review “by market share so that we have made sure that we are looking at the companies with large market share that would have the most impact,”  and that “there are only about five companies that have the vast majority of the market share.” She also committed to “do everything I can to make sure that we have reviewed and finished all the high market share company applications because they will have the most impact on this problem.” 

 

FDA has not ruled on a PMTA from any company with significant market share.

 

Today’s letter follows an extensive investigation into flavored e-cigarettes by the Subcommittee on Economic and Consumer Policy.

 

On July 24, 2019, and July 25, 2019, the Subcommittee on Economic and Consumer Policy held two hearings entitled:  “Examining JUUL’s Role in the Youth Nicotine Epidemic:  Part I,” and “Examining JUUL’s Role in the Youth Nicotine Epidemic:  Part II.”

 

On December 4, 2019, the Subcommittee on Economic and Consumer Policy held a hearing entitled “The Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, and the Food and Drug Administration’s Compliance Policy.”

 

On January 2, 2020, Chairman Krishnamoorthi condemned the Trump Administration’s weakened vaping guidance, which broke the former President’s promise to protect America’s youth by clearing the market of all e-cigarette flavors, including menthol.

 

On January 23, 2020, the Chair sent a letter to FDA about its plans to enforce the Trump Administration’s partial ban on flavored vaping pods, requesting the FDA monitor, in real time, the large number of children who will migrate to menthol e-cigarettes from other now-banned flavors.

 

On June 23, 2021, the Subcommittee on Economic and Consumer Policy held a hearing entitled “An Epidemic Continues:  Youth Vaping in America,” to examine the scope of the youth vaping epidemic and the role of the federal government in addressing youth e-cigarette use and addiction going forward.

 

On April 29, 2021, the Chair applauded FDA’s announcement of its plan to ban menthol cigarettes to protect public health and contribute to racial justice.

 

Click here to read today’s letter.

                

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117th Congress