The FDA on Wednesday unveiled its long-awaited policy for restricting youth access to flavored e-cigarettes, and the actions were widely criticized by health groups as insufficient to reverse the epidemic rise in e-cigarette use among teens and young adults.
Outgoing commissioner Scott Gottlieb, who will be leaving the agency next month, announced that the FDA is proposing to speed up full enactment of restrictions on most flavored e-cigarette products, with immediate “prioritized enforcement” and cutting a year off the 5-year grace period for certain regulations that the agency promised in 2017.
The “FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products,” according to a statement.
In addition, manufacturers of fruit, candy, and other non-tobacco, mint, or menthol-flavored products that remain on the market under the new policy will be asked to submit premarket applications to the FDA by early August 2021, which is a year earlier than the application deadline previously proposed by the agency.
In his statement, Gottlieb said the FDA move is likely to result in some flavored e-cigarette and flavored little cigar products being removed from the market.
He also vowed to “prioritize enforcement” to prevent retail and online sales of flavored electronic nicotine-delivery systems (ENDS) to youth.
“Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization,” Gottlieb said.
The agency is excluding tobacco-, mint-, and menthol-flavored e-cigarettes and other ENDS unless those products are sold in a way that targets minors. Gottlieb has long argued that e-cigarettes may be useful for helping adult smokers quit combustible cigarettes, and the more traditional flavors may help in that.
At a November press conference held to announce new restrictions on the sale and marketing of e-cigarettes, Gottlieb said the survey data “shock my conscience,” and he vowed to take immediate steps to restrict the access of e-cigarettes by minors.
But the actions announced on Wednesday were disparaged by advocacy group leaders, who said they do not do enough to protect youth from e-cigarettes.
“We appreciate that while [the] FDA has recognized the magnitude of the problem, frankly we are underwhelmed by today’s announcement,” American Heart Association CEO Nancy Brown said. “We don’t think the FDA has gone far enough to reverse the epidemic of youth addiction to e-cigarettes.”
Brown was especially critical of the exclusion of mint- and menthol-flavored products from the policy directives, noting that mint and menthol flavors are popular among younger e-cigarette users.
Erika Sward of the American Lung Association told MedPage Today that the FDA’s latest action will have “little or no impact on the youth e-cigarette epidemic.”
“They are nibbling around the edges of the problem, and failing to take meaningful action,” she said.
Campaign for Tobacco Free Kids president Matthew Myers noted that while Gottlieb deserves credit for focusing attention on the epidemic rise in youth e-cigarette use, “a public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA.”
“It is important to note that today’s announcement is a ‘draft guidance’ with no deadline for issuing a final policy or enforcing it. It is also disappointing that the FDA has yet to propose rules to ban all flavored cigars and menthol cigarettes as it promised to do in November,” Myers said.
Myers noted that with Juul and other mint and menthol e-cigarettes still widely available online and at convenience stores and other retail establishments, “it is doubtful the FDA’s new policy will stem the tide of youth e-cigarette use.”
“The FDA must do more and do so quickly,” he said. “It should prohibit all flavored e-cigarettes that have not been subject to public health review by the agency, halt online sales of e-cigarettes until stronger safeguards are in place to prevent sales to kids, restrict marketing that attracts kids, and enforce rules prohibiting the sale of new products without FDA authorization.”