The agency will allow mint- and menthol-flavored e-cigarettes to continue to be sold at all retailers until it removes menthol cigarettes from the market. Officials worry that in removing menthol e-cigarettes from places where menthol cigarettes are sold, consumers might opt for conventional cigarettes. However, Gottlieb said the agency will reconsider the exemption if data show kids are using these products.
Anti-tobacco groups applauded the FDA taking some action but said it didn’t go far enough. Truth Initiative CEO Robin Koval told CNBC she urges the agency to ban flavored e-cigarettes outright and, in the meantime, include mint in the retail restrictions.
E-cigarette manufacturers that wish to sell flavored products more broadly in the future must first submit the products to the FDA to review and authorize. The FDA will require products that are found illegally being sold in stores to undergo review and would be pulled from the market until the agency completes the application process and clears it, which it may not. In the process, known as a premarket tobacco application, products must prove they deliver a net public health benefit.
All e-cigarettes currently on the market will eventually go through this process. Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022, so manufacturers would have more time to file complete applications.
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 this extension and be required to undergo review.
Gottlieb said the FDA will explore how to accelerate the process for new technologies that prove they can keep kids from using them. Fontem Ventures, a unit of Imperial Brands and maker of blu e-cigarettes, and Juul have both said they plan to test new connected devices outside of the U.S.
Some manufacturers have already started taking action on flavors. Altria said it will voluntarily remove its MarkTen pod-based products from the market and will stop selling all flavors except for menthol or tobacco in its “cig-a-like” products until the FDA reviews and clears them.
Juul, the clear e-cigarette market leader, on Tuesday stopped accepting retail orders for its mango, fruit, creme and cucumber pods from the more than 90,000 convenience stores, vape shops and other retailers that sell them, CEO Kevin Burns said Tuesday in a blog post on the company’s website. Juul plans to resume sales to retailers that are legally allowed to sell flavored e-cigarettes and adopt the company’s new age restrictions and verification system, though it’s unclear when sales could resume.
In a statement Thursday, Juul said it is “committed” to working with the FDA and others to prevent minors from using e-cigarettes. Japan Tobacco International said it looks forward to ongoing discussions with the FDA “to further understand and support the development of these proposals.”