Juul Makes Another PMTA Push, Age Verification Available via App

JUUL's official website announced on July 19 that Juul Labs has submitted a PMTA application to the FDA for its next-generation platform. The application includes comprehensive scientific evidence regarding the new device and a new tobacco flavor tobacco stick with a nicotine concentration of 18mg/ml, as well as information about new technologies to restrict underage use.

Official information shows that the product for which the PMTA application was submitted is the JUUL2, which has been on the market in the UK since 2021. The submitted JUUL2 application mainly includes the following features:

1. The device has Bluetooth functionality and a larger, longer-lasting battery; 2. An "intelligent indicator light system" that displays remaining battery and e-liquid in real-time; 3. Newly designed tamper-proof tobacco sticks that improve vapor transmission; 4. New heating elements that enhance product performance and temperature control accuracy; 5. Tobacco sticks equipped with Pod ID chips to prevent the use of illegal counterfeit and compatible tobacco sticks; 6. Support for age verification and device locking through a connected app; 7. Real-time product information and usage data for age-verified users; Juul's Chief Regulatory Officer Joe Murillo stated that the next-generation platform for which the PMTA application was submitted is built on new technology, providing compelling scientific evidence of its significant benefits to public health to meet the necessary conditions for PMTA approval. Additionally, Juul mentioned in this announcement that it has submitted three PMTA applications: the first for devices on sale submitted in July 2020, the second for new tobacco flavors for devices on sale submitted in December 2022, and this latest submission for the JUUL2 device and tobacco sticks. Currently, the application for the first-generation product submitted in July 2020 was banned by the FDA, but the administrative appeal is still under review, so it remains on the US market.

For Juul, the outcome of this application will significantly impact its future direction in the US market. Due to the previous MDO ban issued by the FDA and the need to spend heavily to settle with various states over the issue of underage use of e-cigarettes, Juul has suffered greatly in recent years, with its market share continuously declining. The latest Nielsen convenience store data from May shows that its market share in the US has dropped to 26%, far below Vuse's 41.8%. Although Juul's market share is still higher than NJoy's 2.7% and blu's 1.4%, the fact that Altria has completely abandoned its 35% stake and turned to acquire NJoy has led to a severe shrinkage of Juul's sales channels, facing pressure from NJoy, which is rapidly catching up with the support of Altria's channels. It is particularly noteworthy that despite this being Juul's third PMTA application submission, according to the FDA's current progress (which will not complete the review of existing applications until the end of 2023), Juul will still be without a PMTA for a considerable time. In contrast, NJoy holds PMTAs for multiple products, including pod-based and disposable products, all of which are its main products on sale. Thus, it appears that Juul has still not resolved the ongoing crisis of declining market share.