US regulator authorises first flavored vape products

The US Food and Drug Administration (FDA) authorised four of menthol e-cigarette products by Njoy, a subsidiary of US tobacco giant Altria, for sale in the country on Friday, making them the first ever flavored vapes the agency has permitted on the market.

The decision shows vape makers can provide evidence satisfying the FDA that the benefits their products offer in terms of helping smokers quit outweigh the risks posed to youth.

“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorisation, and the FDA has made clear what’s needed to successfully achieve that outcome,” said Brian King, director of the FDA’s Center for Tobacco Products.

“This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”

The FDA issued marketing granted orders to Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5%, and Njoy Daily Extra Menthol 6%. The two authorised Ace products are pre-filled, non-refillable pods that are used with the previously authorised Ace device, and the two authorized Daily products are disposable vapes.

Njoy Ace remains the only pod-based vape product with marketing authorisation from the FDA, and now Njoy has the first and only menthol vape products authorized by the FDA to date.

“Altria is Moving Beyond Smoking, taking action to transition millions of adult smokers to potentially less harmful alternatives. We’re pleased the FDA has determined that Njoy menthol e-vapor products are appropriate for the protection of public health,” said Billy Gifford, Altria’s chief executive.

The FDA first began regulating vapes in August 2016 and it has authorised 27 e-cigarette products for sale in the US to date, including Njoy’s menthol vape products.

As per the terms agreed during the acquisition of Njoy last year, Altria is obligated to pay $250 million in additional cash payments to Njoy as a result of the FDA’s issuance of the marketing granted orders.

Last month, Njoy submitted a supplemental application to the FDA to commercialise and market the Njoy Ace 2.0 device. This device incorporates access restriction technology designed to prevent underage use via Bluetooth connectivity to authenticate the user before unlocking the device.

Njoy also re-submitted applications for Blueberry and Watermelon pod products that work exclusively with the Njoy Ace 2.0 device, and if the applications are approved, the company will get up to $250 million under the merger agreement.