| Section | Link to Section |
|---|---|
| JUUL Device | The New Device May Not Bear The JUUL Name. |
| FDA Still Awaiting Re-Review | The FDA Is Still Awaiting A "Re-Review" Of The Original JUUL. |
About two years after the product's launch in the UK as the JUUL2, Juul Labs is requesting FDA approval to sell a second-generation gadget in the US. Juul declared today that it has filed a premarket tobacco application (PMTA) for the gadget and refill pods with tobacco taste.
Until Juul obtains a marketing given order (MGO) from the FDA, it will not be permitted to sell the new device in the United States. According to the FDA Deeming Rule, before a product created with nicotine derived from tobacco that was not on the market as of August 8, 2018, can be sold, it must receive FDA approval. Three years after it was submitted, the PMTA for the company's original JUUL gadget is still being reviewed by the FDA.
Juul should anticipate at least two years before the FDA makes an initial determination regarding whether the new device is "appropriate for the protection of public health"—and potentially years of legal wrangling after that, given the agency's history of reviewing and deciding on PMTA submissions.
The New Device May Not Bear The JUUL Name.
The gadget is equipped with Bluetooth technology and a mobile and web application that permits age verification, locks down the device, and prohibits the use of "compatible" Juul pods from third parties. Although Juul claims that this is "just the beginning of new tech being developed" for the American market, the company did not provide an explanation for why it took two years after the JUUL2's launch in the UK for the FDA to approve the device. In Canada, the JUUL2 is marketed as well.
Given that the JUUL2 will only be compatible with nicotine-strength pods containing 18 mg/mL, it is imperative that the gadget have "improved airflow capability" in comparison to its predecessor. The current JUUL pods come in two strengths: 5 percent (59 mg/mL) and 3 percent (36 mg/mL) in the United States. According to JUUL research, the new gadget produces more vapor per puff, which enables it to provide the user with higher nicotine levels even when using e-liquid that isn't as strong.
Juul Labs reports that after six months of use, over 32% of JUUL2 users in the UK transitioned entirely from combustible cigarettes.
Juul has not yet determined whether to sell the next-generation JUUL device under the Juul brand, according to a Wall Street Journal report published today.
The FDA Is Still Awaiting A "Re-Review" Of The Original JUUL.
Juul has yet to receive a definitive response from the FDA regarding the PMTA it filed in July 2020 for its flagship JUUL device. Juul's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health," according to the FDA, which rejected the PMTA and issued Juul a marketing denial order (MDO) in June 2022.
A federal judge promptly granted Juul a temporary stay of the MDO; however, the FDA swiftly withdrew its own rejection decision and granted an administrative stay, putting Juul's appeal on hold.
