Senators Collins, Durbin Lead Call Urging FDA to Strengthen Efforts to Reduce Youth Vaping

Letter comes as the White House calls on FDA Commissioner Makary to approve flavored vapes that have been found to have increased youth appeal.

WASHINGTON, D.C. - Today, U.S. Senators Susan Collins and Dick Durbin (D-IL) sent a bipartisan letter to U.S. Food and Drug Administration Commissioner Marty Makary urging the agency to reconsider its recently issued draft guidance document, Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications - Considerations Related to Youth Risk. The Senators warned that this guidance could increase the number of flavored e-cigarettes or electronic nicotine delivery systems authorized by FDA, jeopardizing recent progress in reducing youth e-cigarette use.

Their letter follows reports that indicate that President Trump has pressed FDA Commissioner Marty Makary to move more quickly to approve flavored vapes and nicotine products that Commissioner Makary previously declined to authorize amid concerns about the public health risks and potential appeal to children.

"FDA must be careful to avoid changes that could jeopardize recent progress in reducing the number of youth who use e-cigarettes," the Senators wrote. "Tobacco use often begins during adolescence, when people are more vulnerable to nicotine addiction and less aware of the risks of tobacco use. Nicotine can harm the parts of the adolescent brain responsible for attention, learning, mood, and impulse control and can prime the brain for addiction to other drugs."

"We appreciate FDA's recognition that the products that most egregiously target kids would face a 'correspondingly high evidentiary burden to demonstrate that the benefits to adult smokers…outweigh the risks of youth initiation,'" they continued. "As sponsors of the 'Family Smoking Prevention and Tobacco Control Act' (P.L. 111-31), we intended FDA's premarket review of new tobacco products to be utilized as an important tool to prevent new products from entering the market that are likely to increase youth use of tobacco. This draft guidance will increase the number of flavored e-cigarettes that FDA authorizes."

"Given the importance of preventing youth use of all tobacco products and the strong evidence that flavors increase the appeal and use of e-cigarettes by youth, FDA should not ignore the basic reality that kids are drawn to what flavors are most available to them, particularly since FDA recognizes the underlying risk of flavors to youth… We request a timely response that addresses the concerns we have about the new draft guidance," the Senators concluded.

Click here to read the complete text of their letter.

Senators Collins and Durbin have repeatedly worked together to crack down on youth vaping and hold e-cigarette manufacturers accountable. In 2020, they introduced the bipartisan Resources to Prevent Youth Vaping Act to force e-cigarette manufacturers to pay FDA user fees to strengthen oversight and youth vaping prevention efforts. In 2022, they co-led the successful effort to close the synthetic nicotine loophole, ending an industry tactic that allowed kid-friendly, flavored e-cigarettes to evade FDA regulation. In 2024, Senators Collins and Durbin pressed the Department of Justice and FDA interagency task force to crack down on the illicit sale and distribution of unauthorized e-cigarettes, warning that thousands of kid-friendly flavored products remained readily available for purchase.

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