The U.S. Food and Drug Administration (FDA) should reassess its recently issued draft guidance on electronic cigarettes to avoid jeopardizing recent progress in reducing youth e-cigarette use, urged U.S. Sen. Susan Collins (R-ME) this week.
“We believe that this draft guidance could risk the health of children by increasing the number of flavored e-cigarettes that FDA authorizes,” wrote Sen. Collins and U.S. Sen. Dick Durbin (D-IL) in a May 5 bipartisan letter sent to FDA Commissioner Marty Makary.
Specifically, the senators expressed concerns with the FDA’s draft guidance document, “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.”
They warned that the guidance could increase the number of flavored e-cigarettes or electronic nicotine delivery systems authorized by the FDA.
“For flavors characterized as less risky to youth by FDA, the agency is suggesting it would require a product to show a relatively small benefit to adults compared to tobacco-flavored products to be ‘appropriate for the protection of the public health,’” wrote the senators. “It is unclear how FDA is identifying and justifying the relative risk profile of certain flavors, given that the flavors that FDA seeks to categorize as less risky to youth (e.g. mint, menthol, coffee, and spice) are still attractive to youth and often used by them.”
Their letter follows news reports that indicate President Trump has pressed Makary to move more quickly to approve flavored vapes and nicotine products that the commissioner previously declined to authorize amid concerns about the public health risks and potential appeal to children.
“We are concerned that the draft guidance, if finalized in its current form, would create more risk than benefit to public health and should be reconsidered,” wrote the senators. “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.”
Sen. Collins and Sen. Durbin requested that Makary provide them with “a timely response that addresses the concerns we have about the new draft guidance.”