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Shaheen Joins Bipartisan Group of Senators Urging HHS to Address Repeated Failures at FDA to Regulate E-Cigarettes

(Washington, DC) – U.S. Senator Jeanne Shaheen (D-NH) joined a bipartisan letter, led by Senate Majority Whip Dick Durbin (D-IL), to the Department of Health and Human Services (HHS) Secretary Xavier Becerra condemning the delays by the Food and Drug Administration (FDA) to regulate e-cigarettes, failure to enforce the law and take action against companies marketing illegal vaping products and the harm to children’s health from the agency’s inaction. The FDA is currently 16 months past a court-ordered deadline to finish reviewing e-cigarette applications. Last week, the FDA submitted filings disclosing that it will take nearly another year for the 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 the FDA misses the court order.

The Senators wrote, “We write to once again draw your attention to the repeated failures of the Food and Drug Administration (FDA) to regulate the tobacco and e-cigarette market. While we understand the incredible pressures that the FDA is under across its portfolio of regulated products, the FDA’s failures cannot be excused away by a heavy workload. For nearly a decade, the agency has neglected its duty under the law to regulate e-cigarettes, jeopardizing the health of millions of children. Now, after yet another delay in the FDA’s efforts to regulate the e-cigarette marketplace, it is now clear to us that the FDA is adrift and lives are at risk.”

They continued: “To be clear, the FDA’s hapless e-cigarette oversight began when the prior administration made the decision in 2017 to delay implementation of the Deeming Rule, which had provided the FDA with the authority to regulate vaping products. This delay led to millions of e-cigarettes illegally flooding the market without proper authorization as required under the Tobacco Control Act. These delays, coupled with aggressive and misleading advertising—targeted at children and pulled straight from Big Tobacco’s playbook—helped to ignite the youth vaping epidemic.”

The U.S. District Court for the District of Maryland ordered the 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, these e-cigarettes are being sold and addicting children today only because the FDA has exercised enforcement discretion, and allowed these products to remain on the market despite not having authorization as the law requires.

This week’s letter follows a scathing independent report from the Reagan-Udall Foundation that found the 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.”

In addition to Shaheen, the letter was signed by Senators Mitt Romney (R-UT), Jeff Merkley (D-OR), Lisa Murkowski (R-AK), Richard Blumenthal (D-CT), Ed Markey (D-MA), Tammy Duckworth (D-IL), Sherrod Brown (D-OH), Elizabeth Warren (D-MA), Tammy Baldwin (D-WI), Jack Reed (D-RI) and Sheldon Whitehouse (D-RI).

Full text of the letter is available here.

Senator Shaheen has prioritized efforts in the Senate to tackle the youth vaping crisis. Last year, Shaheen helped reintroduce the No Tax Subsidies for E-Cigarette and Tobacco Ads Act, which would crack down on e-cigarette companies and close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising for e-cigarettes and tobacco products. She led the bipartisan, bicameral introduction of the Resources to Prevent Youth Vaping Act, which would require that e-cigarette manufacturers pay user fees to the Food and Drug Administration (FDA) to help to fund more activity at the FDA to conduct stronger oversight of the e-cigarette industry and increase awareness for the danger of e-cigarettes. In the FY 2023 government funding bill, Shaheen helped negotiate more than $2.408 billion in funding for the Substance Abuse Prevention and Treatment Block Grant. The proposal also includes report language added by Shaheen to address youth e-cigarette use and encourages NIDA to support research to develop therapies to combat pediatric nicotine addiction. In March of 2022, Shaheen joined a bipartisan group of Senators in calling on the Food and Drug Administration (FDA) to take long-overdue action to combat the youth vaping crisis, including steps that could remove kid-friendly, addictive e-cigarettes from the market.