March 21, 2022
(Washington, DC) – US Senator Jeanne Shaheen (D-NH) and Senator Maggie Hassan (D-NH), a member of the Senate Health, Education, Labor, and Pensions Committee, joined a bipartisan group of their Senate colleagues 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.
A US District Court judge for the District of Maryland previously ordered the FDA to complete a review of e-cigarette products to determine whether these products are a danger to the public health and should be removed from the market. Despite a court-ordered deadline of September 9, 2021, the FDA still has not completed its review, including for the most popular e-cigarette products, such as Juul. The FDA and Centers for Disease Control and Prevention’s (CDC) National Youth Tobacco Survey found that more than two million youth used e-cigarettes in 2021.
“Contrary to its initial plan, FDA has not prioritized review of e-cigarettes with the largest market share and therefore greatest public health implication. Instead, it has deferred its decisions on the most critical applications — including for those products that are most popular with youth — to the end. As a result, six months after FDA was supposed to have completed its reviews, e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market, ” the Senators wrote in a letter to FDA Commissioner Robert Califf.
“Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act‘s statory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users. FDA has the authority and responsibility to halt this grace period today and restore the statory burden of proof on manufacturers to demonstrate their product is ‘appropriate for the protection of public health’ prior to market entrance, ” the Senators continued.
“It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine,” the Senators concluded.
In addition, Shaheen and Hassan recently supported a measure in the most recent government funding bill that ensures that the FDA can regulate synthetic nicotine found in e-cigarettes, an important step to help address youth vaping.
Senators Shaheen and Hassan have long prioritized efforts in the Senate to tackle the youth vaping crisis. Senators Shaheen and Hassan have repeatedly pushed for the removal of flavored e-cigarettes from the market and to stop delaying action in implementing the planned restrictions on flavored products. Shaheen has focused on closing the FDA’s user fee loophole for e-cigarettes since early 2019, when she first introduced the legislation to require e-cigarette companies to pay fees to the FDA to help fund federal prevention and enforcement efforts. She’s also held multiple meetings with students, educators, law enforcement and health officials across the state about the ongoing public health concern. She introduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act in the last session of Congress, which would close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising e-cigarettes and tobacco products. Senator Hassan has also led a bipartisan group of her colleagues in expressing concerns regarding the FDA’s former guidance on vaping, including the FDA’s refusal to ban menthol-flavored vaping products. In addition, Senator Hassan helped to promote National Prescription Drug Take Back Day, highlighting the leadership of Manchester students in ensuring that vaping devices and accessories could be accepted.
Full text of the letter is available here.