Puff Bar blames U.S. retailers and Chinese manufacturers for the youth initiation issues. Read More
Litigation
News This Week
PMTA
Regulation
U.S. FDA
Second Chance: MDO Legal Win Presents Opportunity
How companies can make the most of a recent ruling requiring FDA to reassess 1,000s of PMTA rejection notices.Read More
Gripum claims the MDO was unfairly issued because Congress and FDA had no “ascertainable standards."Read More
Litigation
News This Week
PMTA
Regulation
U.S. FDA
Vapor Makers Prevail Over FDA in PMTA Denial Suit
The FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).Read More
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
