New FDA Guidance on E-Cigarettes Opens Door Wider for Authorization of Flavors that Attract Kids

WASHINGTON, D.C. – New guidance issued this week by the FDA regarding marketing applications for flavored e-cigarettes opens the door wider for the FDA to authorize flavored products, including flavors like mint that historically have been widely used by youth. This guidance puts kids at risk by lowering the scientific standard required of industry for certain flavors and making it easier for flavored products to gain FDA authorization.

This guidance is especially troubling in light of the clear scientific evidence, summarized in the guidance itself, that flavors attract youth and play a key role in youth use of e-cigarettes and other tobacco products. Given this evidence, the FDA should not be lowering the evidentiary standard e-cigarette manufacturers must meet to gain authorization for flavored products – a standard that has been upheld by the U.S. Supreme Court.

The guidance also ignores evidence that kids are likely to shift to whatever e-cigarette flavors are available on the market. For example, as other flavored products exited the U.S. market in late 2018, youth use of mint and menthol flavors increased by 50%. These flavors remain prominent among U.S. youth who use e-cigarettes. In light of this history, it is especially troubling that the FDA’s guidance states that mint “may present a lower risk of youth initiation and use.”

It is also concerning that this guidance was issued with little opportunity for public comment, including by public health organizations. Such a substantive change in the FDA’s approach to marketing applications for flavored e-cigarettes should be transparent and involve engagement with all stakeholders, not just the tobacco industry.