Juul Labs seeks authorization for age-restricted products

Juul Labs seeks authorization for age-restricted products

Juul Labs submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for its Next Generation Platform (NGP) device and mint-flavored pods that require user age verification.

The submission includes comprehensive science and evidence that the new mint-flavored pods, with 18 milligrams of nicotine per milliliter, will be used with Juul Labs' next-generation device in July 2023, according to a statement from the company. PMTA and tobacco-flavored pods submitted to FDA.

Juul writes on its website: "Our next-generation ENDS (electronic nicotine delivery system) platform, initially launching in the UK in 2021 as 'Juul2', provides adult smokers with an enhanced vaping experience, leveraging a unique Pod ID authentication to address illegal products and incorporates age verification technology capabilities." "This latest position paper advances our commitment to address two public health issues: prompting adult smokers to abandon the use of combustible cigarettes and restricting the use of combustible cigarettes to minors. Human exposure to vapor products.”

Each NGP-compatible menthol capsule contains a secure microchip that communicates age verification requirements to the NGP device prior to use. The NGP device itself can be further locked by the user at any time to prevent unauthorized use. In addition to limiting the number of devices that can be purchased, Juul Labs will also limit the number of new devices each age-verified user can activate and use the mint-flavored pods to further reduce the risk of social purchasing.

Juul also wrote: "Technological advancements enabling device-level age verification complement Juul Labs' programmatic efforts since its 2019 relaunch to address underage use of its products."

The next-generation platform can be used with mobile or web applications that support age verification technology, including device locking and real-time product information, as well as age-verified consumer insights.

Since the apps are already available in other markets, Juul Labs said it adheres to industry-leading data privacy protections in compliance with the European Union's General Data Protection Regulation. For example, NGP-compatible Juul mobile apps and web apps do not transmit any customer location data to Juul Labs; the location data needed to provide app functionality is stored locally on the customer’s smartphone or computer.

Likewise, the company doesn't have access to consumers' device usage (e.g., puff) information.

Device usage information required to provide the functionality of the application is stored either locally on the customer's smartphone or computer or in an end-to-end encrypted backup of the customer's choice.

In June 2022, the FDA rejected marketing authorization for the Juul system, which is currently on the market. Juul Labs challenged the order in court and its products remain on the U.S. market pending an administrative review.
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