Sen. Susan Collins (R) has teamed up with Sen. Dick Durbin (D-IL) to encourage Food and Drug Administration (FDA) Commissioner Marty Makary to reconsider the agency’s recently issued draft guidance document concerning flavored vapes.
The senators express concern in their letter that the change in policy could result in an increase in the number of flavored e-cigarettes or electronic nicotine delivery systems authorized by the FDA, which they suggest would “jeopardiz[e] recent progress in reducing youth e-cigarette use.”
In a press release shared by Sen. Collins’ office Tuesday, she cites a report from the Wall Street Journal that President Donald Trump has urged Commissioner Makary to approve more flavored vapes and nicotine products, including those which he had previously declined to give the green light to over health concerns.
“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,” they said. “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.
The senators then go on to reference their joint sponsorship 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,” they wrote. “This draft guidance will increase the number of flavored e-cigarettes that FDA authorizes.”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,” the senators concluded.
They then asked that the Commissioner respond to their concerns about the new draft guidance in a “timely” manner.
Collins and Sen. Durbin have worked together on this issue multiple times since 2020.
Click Here to Read Sen. Collins’ Full Press Release
This week, the FDA authorized the first fruit-flavored electronic cigarette products.
Approved were four flavored e-cigarette products from Los Angeles-based company Glas Inc., with mango, blueberry and two different menthol varieties. The products will be sold under the names Gold, Sapphire, Classic Menthol and Fresh Menthol.
Federal regulators explained the now-approved products are intended for adults trying to quit or reduce cigarette smoking, emphasizing that the move is not an endorsement for vaping.
Previously, only tobacco- and menthol-flavored products were cleared by the agency.
According to the FDA, Glas employs a digital age-verification system to limit underage individuals from using its products. In order to use the products, age must be verified on a cellphone with a government-issued ID. Their vaping devices are only operational when connected via Bluetooth to a verified phone.
