US
The US Food and Drug Administration (FDA) will restrict sales of most flavored e-cigarettes to age-restricted stores and pursue bans on menthol cigarettes and flavored cigars.
In a statement released on November 15, 2018, Commissioner Gottlieb outlined a slew of policies and essentially threatened to pull products from the market if manufacturers do not follow them. This will effectively ban most flavored products from convenience stores and gas stations while permitting them in roughly 10,000 tobacco and vape shops.
For mint- and menthol-flavored e-cigarettes, FDA will allow them to continue to be sold at all retailers until it removes menthol cigarettes from the market. However, Gottlieb said FDA will reconsider the exemption if data show kids are using these products.
For e-cigarette manufacturers that wish to sell flavored products more broadly in the future, they must first submit the products to FDA to review and authorize. Products that are found illegally being sold in stores will have to undergo review and would be pulled from the market until FDA completes the application process and clears it, which it may not. In this premarket tobacco application process, products must prove they deliver a net public health benefit.
And last but not least, companies who do not comply with new FDA-mandated age verification guidelines for online sales or are marketed to children, including by using popular children’s cartoons or names of kid-favorite products like brands of candy or soda, would lose the extended deadline until August 8, 2022 to submit complete applications and be required to undergo review.
Gottlieb acknowledged it could take weeks, if not months, for retailers to fully adjust to the flavored e-cigarette changes. He also said that FDA will explore how to accelerate the process for new technologies that prove they can keep kids from using them.
Menthol cigarettes and flavored cigars can expect new rules next year. Gottlieb declined to give a time frame for when it could finalize a menthol ban but said FDA “should be able to move with some added efficiency.”