The court ruled FDA acted within Congress' authorization, and decisions were supported by evidence. Read More
The court denied the stay mainly because Fontem waited too long to file the emergency motion.Read More
The limited product debut in the UK has received overwhelming recognition from users and commercial partners.Read More
The agency says there are scientific issues unique to the Juul application that warrant additional review.Read More
Juul Labs also said the agency failed to consider the totality of Juul’s evidence of the public-health benefits of Juul.Read More
Juul Labs filed an emergency motion with the U.S. Court of Appeals as it prepares to appeal the FDA´s decision.Read More
Currently marketed Juul products must be removed from the U.S. market unless a U.S. court intervenes. Read More
It is expected that Juul will receive the MDO in a response to its PMTA because of its appeal to youth.Read More
The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. Read More
FDA states that it expects to have resolved 63 percent of PMTAs set out in its original priority by June 30.Read More