US-based electronic cigarette company Juul Labs announced on Friday that the United States Food and Drug Administration has issued marketing granted orders for the company's next generation JUUL2 System with tobacco- and menthol-flavoured pods.
Juul Labs submitted JUUL2 System Premarket Tobacco Product Applications to FDA in 2023, and offered tens of thousands of pages of scientific evidence, including nonclinical, clinical, behavioural, and population science data. Subsequent to the rigorous assessment of the data, FDA determined that the JUUL2 System is 'appropriate for the protection of the public health', the statutory standard needed for market authorisation.
The JUUL2 System is designed by the company's team of US-based engineers and scientists, and includes a range of innovative technology intended at offering an appealing, smokefree alternative. It is available in various other international markets, including the United Kingdom, and FDA's marketing order enables Juul Labs to bring this technology to US adult consumers.
The firm assembles and fills JUUL2 pods in US manufacturing facilities in Tennessee and Wisconsin, with e-liquids made in Maryland.
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
NeuroSense reveals strategy to advance PrimeC toward potential ALS approval
UCB agrees with US government to lower medicine costs and strengthen US manufacturing
Karyopharm seeks accelerated FDA approval for selinexor–ruxolitinib in myelofibrosis