According to a foreign news report, Fontem US e-cigarette company, a subsidiary of ITG, the third largest tobacco company in the United States, has submitted to the FDA (US Food and Drug Administration) a pre-market tobacco product application (PMTA) for myblu e-cigarettes in order to seek authorization to continue to sell fog Electronic cigarette products.
ITG is a member of the Empire brand. The company launched the myblu product in February 2018.
Fontem US submitted a product application for myblu, which aims to provide adult smokers with a less harmful option than combustible tobacco products.
The materials submitted by PMTA include data from a wide range of laboratory and clinical scientific research, including product analysis, behavioral data, non-clinical health risk information, and information about the impact on tobacco product users and non-users.
Fontem US believes that the evidence provided shows that, according to FDA guidance, myblu electronic atomization products can play a role in protecting public health. Fontem US is now awaiting FDA review of the application and will provide other information the agency seeks.
Fontem US President Antoine Jinfa said, we agree that the e-cigarette industry should maintain the highest product and marketing standards, while providing adult smokers with alternative products, these products should be in the interest of public health. Fontem US hopes to cooperate with the FDA when the agency formulates and implements evidence-based regulatory policies.
Mitch Zeller, director of the FDA Tobacco Products Center, said that more than 30 PMTAs have been submitted to the FDA. Logic and RJ Reynolds are the only manufacturers to announce PMTA submissions, and Reynolds submitted other products last week.
At present, due to the global pandemic of the new coronary pneumonia, the FDA has announced that the PMTA deadline has been postponed from May 12, 2020 to September 9, 2020. This will leave more preparation time for e-cigarette companies.