ADA urges FDA to reconsider proposed pathway for flavored e-cigarette authorizations

Public health, medical, civil rights and community organizations, including the ADA, are urging the U.S. Food and Drug Administration to revise portions of its proposed guidance on flavored electronic nicotine delivery systems, arguing that the agency’s new framework could weaken protections for youth and allow more flavored vaping products onto the market.

In comments submitted May 11 on the FDA draft guidance “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” the coalition said it supports the FDA’s long-standing position that flavored e-cigarettes pose “a substantial risk to youth” and should face strict scientific review before receiving marketing authorization.

The groups endorsed the FDA’s requirement that manufacturers prove flavored products provide a benefit for adults trying to quit smoking beyond what tobacco-flavored products already offer.

“We support FDA’s continued requirement that a marketing order applicant bear the burden of showing, by the strongest kinds of scientific evidence, that its flavored product confers an added benefit, compared to a tobacco-flavored product, in helping adults who smoke to stop smoking,” the letter said.

But the organizations criticized the FDA’s proposal to distinguish among non-tobacco flavors based on varying levels of youth appeal. Under the draft guidance, some flavors like menthol could be treated as presenting lower youth risk than fruit or candy flavors and therefore require less evidence of adult benefit to gain authorization.

The coalition called that approach “fundamentally flawed,” stating that youth flavor preferences change rapidly, often in response to regulatory actions and product availability.

“The draft guidance fails to recognize the well-established history of significant variations in youth flavor preferences over time, often caused by regulatory decisions themselves,” the letter said.

The organizations pointed to past increases in youth use of mint- and menthol-flavored products after restrictions were placed on fruit- and sweet-flavored cartridge products. The letter said authorizing flavors considered “lower risk” today could shift youth use toward those products in the future.

The coalition also challenged the FDA’s treatment of menthol and mint products as lower-risk flavors. Citing the FDA’s own prior findings, the organizations said menthol has long been linked to increased youth initiation, stronger nicotine addiction and more sustained tobacco use.

“Given FDA’s conclusions that menthol increases initiation of tobacco products, leads to more regular use of tobacco products, makes it harder to stop using such products, makes these products more appealing to youth, and leads to greater youth usage, it is difficult to understand FDA’s classification of menthol ENDS products as ‘lower risk,’” the letter reads.

The organizations also raised concerns about synthetic cooling agents and other chemicals found in mint, menthol and “ice”-style vaping products, stating the FDA should consider chemical composition as well as flavor names when evaluating public health risks.

The groups agreed with FDA that advertising restrictions and sales limitations alone are insufficient to prevent youth access to flavored products. They also expressed skepticism that device access restrictions, or DAR systems, would adequately prevent youth use without strong supporting evidence.

The coalition further argued that there is not enough scientific evidence to justify an easier authorization pathway for certain flavored products. The organizations said there is no scientific consensus that flavored e-cigarettes improve smoking cessation outcomes compared with tobacco-flavored products.

“Because FDA is proposing to rely on this snapshot to potentially authorize certain ‘low risk’ flavors, based on a relatively small countervailing benefit to adults who smoke cigarettes, this fundamental flaw in the Draft Guidance threatens to open the regulatory door to a wider array of FDA-authorized flavored products that will be appealing and accessible to youth, without sufficient countervailing health benefits to adults who smoke,” the coalition concluded.