Durbin Slams FDA On Failure To Regulate E-Cigarettes Two Years After A Missed Federal Court Order
A recent investigation by Durbin’s office found 22 vaping products that currently appear to be sold online by the manufacturer in violation of the law and in defiance of repeated enforcement actions by FDA
WASHINGTON – In a speech on the Senate floor today, U.S. Senate Majority Whip Dick Durbin (D-IL) slammed the Food and Drug Administration (FDA) forits failure to complete its long-overdue review of pre-market tobacco product applications (PMTAs) from e-cigarette manufacturers following the two-year anniversary of a federal court deadline. Since FDA missed the September 9, 2021, deadline, an estimate of approximately two million children may have picked up vaping.
Durbin said, “And despite missing this deadline by two years—FDA remains nowhere close to meeting its legal mandate to regulate these addictive e-cigarettes. You see, under the law, a vaping product is required to apply to FDA before entering the market, and prove to the agency that the e-cigarette is ‘appropriate for the protection of public health.’ This has not happened. Instead, tens of thousands of dangerous, highly addictive e-cigarettes have illegally shown up on store shelves without FDA review, and hooked a generation of children. In fact, studies have found that there are more vaping devices on the market today than there were two years ago when FDA was ordered by a federal court to do something. That’s unacceptable.”
The speech follows a letter Durbin sent today to FDA’s Commissioner Dr. Robert Califf and a letter to Attorney General Merrick Garland urging them to immediately address the youth vaping epidemic. Durbin has slammed FDA for its continued lack of urgency as millions of children have begun using addictive e-cigarettes. For years, FDA has failed to regulate e-cigarettes—currently falling more than two years past a court-ordered deadline to review applications from vaping companies, and refusing to enforce the law and take action against companies marketing illegal vaping products to children. Under the Tobacco Control Act(TCA), e-cigarette companies are required to obtain authorization from FDA prior to entering the market, which the agency has neglected to properly enforce.
Durbin’s office examined FDA’s public data files to identify e-cigarette manufacturers who have received both marketing denial orders and warning letters yet continue to sell unauthorized products, in order to assess FDA’s effectiveness in taking enforcement action against some of the most obviously defiant examples. Durbin’s office found at least 22 vaping products that currently appear to be sold online by the manufacturer in violation of the law and in defiance of repeated enforcement actions by FDA. In addition to those products sold online by the manufacturer, several other such products remain available for purchase from third-party retailers, including one of the most popular e-cigarettes, Breeze Smoke. These products are on the market illegally and pose a significant public health threat, yet FDA has repeatedly and inexplicably shied away from using its full arsenal of enforcement tools granted to the agency by Congress. Durbin’s investigation also found that FDA has only issued “closeout letters” to 10 percent of the 685 tobacco warning letters it has issued since January 1, 2021. A closeout letter indicates that FDA has verified that corrective action has taken place to address the violations contained in the warning letter.
“I just don’t understand it. The Food and Drug Administration is cowardly refusing to use its full arsenal of enforcement tools—like fines and injunctions—for even these most-flagrant cases,” said Durbin. “FDA has only issued ‘closeout letters’ to 10 percent of the tobacco products that it had warned were violating the law… I have referred all of this information to the Department of Justice. Let me be clear: none of the most popular e-cigarettes used by kids have been granted the authority to be sold in the United States by the Food and Drug Administration—and yet they remain on the market in violation of the law putting our children and teenagers in harms way.”
During his speech, Durbin also addressed FDA’s failure to finalize rules to prohibit menthol-flavored cigarettes and flavored cigars.
“This isn’t the only instance where FDA’s delays are dangerous. Last month, FDA also blew through a deadline to finalize rules to prohibit menthol-flavored cigarettes and flavored cigars,” said Durbin. “This regulation is long-overdue and has the potential to save thousands of lives. FDA must end its delays.”
This week, the Senate will consider three government spending bills—including the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill. In light of FDA’s continued delays, Durbin is preparing amendments to this appropriations bill to improve regulatory and enforcement efforts, which he announced in his speech.
“I hope my colleagues will join me in this effort to protect children from Big Tobacco. We have to do something,” said Durbin. “I'm glad to see the bills we're considering this week include bills that have had strong overwhelming bipartisan support.”
In addition to Agriculture, the appropriations bills being considered this week also includes the Military Construction and Veterans Affairs; and the Transportation, Housing, and Urban Development spending bills. These bills would provide veterans with the mental health services they deserve, strengthen and improve our nation’s infrastructure, and ensure women, infants, and children can get the nutrition they need. During his speech, Durbin praised Appropriations Chair Patty Murray (D-WA) and Ranking Member Susan Collins (R-ME) for their work on this bipartisan bill.
“The leaders of each subcommittee drafted bills to the levels agreed upon in the debt ceiling deal made between the Republican-controlled House of Representatives and President Biden,” said Durbin. “The Senate is making good on its promise on this side of the rotunda for the American people by working to fund the government through regular order. I wish Republicans in the House could say the same thing.”
During his speech, Durbin highlighted Speaker Kevin McCarthy’s (R-CA) spending bills, which make significant cuts to education, research, public safety, public health programs, and more. They have yet to pass all of these partisan drafts out of committee.
“Here in the Senate, we are following regular order and working to avoid a shutdown and fund the government without interruption, because we’ve seen the ramifications of putting politics above our duty to the American people. Shutdowns severely reduce GDP, force families to go without paychecks, and signal to our adversaries that we hesitate to make the critical investments necessary to remain competitive and keep our country secure. Last week, I was pleased to hear the Senate Minority Leader say we need to ‘keep the lights on’ by funding the government through regular order. I couldn’t agree more, and I hope House Republicans will meet this moment in history,” Durbin concluded.
Video of Durbin’s remarks on the Senate floor is available here.
Audio of Durbin’s remarks on the Senate floor is available here.
Footage of Durbin’s remarks on the Senate floor is available here for TV Stations.
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