02.15.23

Durbin Invites FDA Commissioner To Visit Vape Shop To See Firsthand The Abundance Of Kid-Friendly E-Cigarettes On The Market

Durbin to FDA Commissioner: On the one year anniversary of your confirmation, your lack of urgency to clear the market of unauthorized vapes is creating serious public health harm for children

WASHINGTON – On the one year anniversary of the Food and Drug Administration (FDA) Commissioner Dr. Robert Califf’s Senate confirmation, U.S. Senate Majority Whip Dick Durbin (D-IL) today sent a letter to FDA slamming the agency for its continued lack of urgency to address youth tobacco use.  For years, FDA has failed to regulate e-cigarettes, refusing to enforce the law and take action against companies marketing illegal vaping products to children.  Due to this inaction, Durbin invited Dr. Califf to join him in visiting one of the many vape shops located in the District of Columbia to see firsthand the sheer volume of unauthorized and flagrantly kid-friendly e-cigarette products that FDA is allowing to be sold to our children. 

FDA is currently 16 months past a court-ordered deadline to finish reviewing e-cigarette applications.  Earlier this month, FDA submitted filings disclosing that it will take nearly another year for FDA to complete its work—until December 31, 2023—for the e-cigarettes with the largest market share.  Approximately one million children are at risk of newly picking up vaping in the intervening time that FDA misses the court order.  

Durbin wrote, “After numerous meetings and calls about the urgency of addressing youth tobacco use, I voted in favor of your confirmation.  I took that leap of faith because I hoped you—unlike your predecessors—would take swift, decisive action to protect our children from a lifetime of nicotine addiction.  One year later, I realize I was wrong… To my dismay, and contradicting federal law, FDA has allowed unauthorized e-cigarette products to enter and remain on the market for years.  And just recently, on your watch, FDA stated that it will not finish review of applications for the most popular e-cigarettes until December 31, 2023—more than two years past a court-ordered deadline to finalize review of these products.  That is stunning.” 

“Your lack of urgency to address this situation is creating serious public health harm,” Durbin continued. “Therefore, I would like to invite you to join me in visiting one of the many vape shops located in the District of Columbia.  Perhaps you would have a greater appreciation for the seriousness and scope of FDA’s failed enforcement if you could see, with your own eyes, the sheer volume of unauthorized and flagrantly kid-friendly e-cigarette products that FDA is allowing to be sold to our children.  For too long, FDA has turned a blind eye to its tobacco enforcement duties.  I hope you will be willing to observe the consequences.” 

The U.S. District Court for the District of Maryland ordered FDA to finish reviewing e-cigarette applications by September 9, 2021, and yet the agency has only completed reviews of about half of those e-cigarettes with submitted applications that represent a large share of the market—leaving dangerous, kid-friendly e-cigarettes, available on store shelves to hook children. 

Most troublingly, the vast majority of e-cigarettes being sold and addicting children today are only on the market because FDA has exercised enforcement discretion and allowed these products to remain on store shelves despite not having authorization as the law requires.  

The letter follows a scathing independent report from the Reagan-Udall Foundation that found FDA’s, “failure to take timely enforcement action jeopardizes public health and undermines creditability and effectiveness in tobacco product regulation.”  It further stated that, “the Agency has not been transparent regarding the reasons it has failed to clear the market of illegal products.” 

Full text of the letter is available here and below:

February 15, 2023 

Dear Commissioner Califf: 

            Exactly one year ago today, you were confirmed by the Senate to once again serve as Commissioner of the Food and Drug Administration (FDA).  After numerous meetings and calls about the urgency of addressing youth tobacco use, I voted in favor of your confirmation.  I took that leap of faith because I hoped you—unlike your predecessors—would take swift, decisive action to protect our children from a lifetime of nicotine addiction.  One year later, I realize I was wrong. 

            FDA is responsible for regulating e-cigarette products.  Under the law, FDA is required to review applications from these tobacco product manufacturers and determine whether each product is “appropriate for the protection of the public health” before entry onto the market.  To my dismay, and contradicting federal law, FDA has allowed unauthorized e-cigarette products to enter and remain on the market for years.  And just recently, on your watch, FDA stated that it will not finish review of applications for the most popular e-cigarettes until December 31, 2023—more than two years past a court-ordered deadline to finalize review of these products.  That is stunning.

            Each day that these products remain on the market absent FDA authorization, more children pick up vaping—ask any teacher, parent, or student across the country.  We can estimate that between now and FDA’s projected timeline, up to one million children are at risk of starting to use e-cigarettes.  I have called on FDA repeatedly to end its dangerous decision to grant enforcement discretion to these unauthorized products.  Put simply: FDA should remove all unauthorized e-cigarette products from the market unless/until these products receive FDA authorization.  This is what the law requires, and it is the responsible thing to do to protect children’s health.

            Your lack of urgency to address this situation is creating serious public health harm.  Therefore, I would like to invite you to join me in visiting one of the many vape shops located in the District of Columbia.  Perhaps you would have a greater appreciation for the seriousness and scope of FDA’s failed enforcement if you could see, with your own eyes, the sheer volume of unauthorized and flagrantly kid-friendly e-cigarette products that FDA is allowing to be sold to our children.   

For too long, FDA has turned a blind eye to its tobacco enforcement duties.  I hope you will be willing to observe the consequences.  Thank you.

Sincerely,

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