JUUL

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December 2023: PMTA submission

Juul Labs submits a Pre-market Tobacco Product Application (PMTA)1 to FDA for menthol-flavored pods (18 mg/mL nicotine concentration) to be used with JUUL2 device. In July 2023, Juul Labs submitted a PMTA for tobacco-flavored pods and JUUL2 device2 – which requires user age verification and is among the first fully age-gated product to be submitted to FDA for review.

JUUL2 was launched initially in the UK in 2021 and utilizes unique Pod ID authentication to address illicit products and to incorporate age verification technology capabilities. Each JUUL2-compatible pod contains a secure microchip that communicates to the device a requirement for age verification prior to use. The device itself can further be 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 that each unique age-verified user can activate and use to further mitigate the risks of social sourcing.

Juul Labs: PMTA Submissions To Date (recall: JUUL section in our “The US FDA: PMTA” write-up)

November 2023: New funding

 JUUL raises $1.27Bn in funding3 from a total offering amount of $1.6Bn. The embattled e-cigarette company has been seeking financing alternatives and cutting jobs in an attempt to stay afloat while dealing with e-cigarette marketing related lawsuits and US FDA’s marketing denial orders (MDOs). According to the latest Nielsen c-store data, JUUL’s share in the US e-cigarette market (in the tracked channels) is now down to mid-20s (from mid-70s at its height). JUUL’s share losses re-accelerated following the MDOs issued in June 2022.

The new funding implies that JUUL managed to convince the investors on two matters (of “life & death” for the whole franchise):

– marketing orders to be eventually granted to JUUL (or, at least, to underage access-restricted JUUL2, for which the PMTA is submitted in July 2023)

NJOY/Altria’s effort to block US imports of JUUL products to be unsuccessful.

References:

  1. https://www.juullabs.com/ngp-pmta-menthol-locking ↩︎
  2. https://www.juullabs.com/next-generation-platform-pmta ↩︎
  3. https://www.reuters.com/article/juul-funding-idTRNIKBN3281QW ↩︎

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