FDA Finalizes Policy on Flavored Vape Products

New guidance falls short of a total ban, leaving a big loophole

IN THE WAKE of spiking e-cigarette use among youth, vaping injuries and a rising death toll, the Chicago Medical Society urged authorities to ban all flavored e-cigarettes pending an investigation. The CMS action in fall 2019 was followed by the American Medical Association (AMA) calling for a total ban on all e-cigarette and vaping products that do not meet FDA approval as cessation tools.

Now, after intense pressure from medical advocates as well as vaping industry groups, the Trump administration has finalized policy that backs away from the president’s initial support for a flavor ban on all non-tobacco products. A statement from the U.S. Department of Health and Human Services (HHS) laid out key details. The stance falls short of what CMS and AMA say is needed to protect young people.

The policy prohibits fruit, mint and dessert flavors in refillable cartridge-based e-cigarettes. HHS argues that flavored refillable products appeal most to teenagers while cartridge-based tobacco and menthol flavors are least popular in this group, and therefore, exempt from the ban, which takes effect February 6, 2020.

Yet, the flavor policy left a big loophole, one that teenagers are quick to exploit. The policy permits all flavors to continue to be sold in nonrefillable disposable devices. And recent reports show rampant use of these disposable vape products among high school students, who have moved on from Juul, which discontinued all its flavors but menthol and tobacco last fall. New competing brands with precharged, prefilled devices, some with higher nicotine levels than Juul, have entered the market.

The HHS said it is trying to strike a balance between protecting children and allowing adult smokers who want to use e-cigarettes as a tool to transition from combustible tobacco. Meanwhile, the FDA will be monitoring e-cigarette companies that fail to adequately prevent youth access to their products.

All companies must apply for preauthorization. Enforcement against those that have not applied will begin May 12, 2020, if the companies continue to sell products.