Fontem US, LLC (Fontem US)–a division of Imperial Brands–has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration, seeking authorization to continue to market its myblu electronic vaping products in the U.S.
Fontem US’ submitted PMTA applications include data from a comprehensive range of laboratory and clinical scientific studies that include product analyses, behavior data, non-clinical health risk information and data on the impact of its products on both users and non-users. According to a press release, the company believes this evidence will show that blu’s products could potentially help protect public health and it could be in-line with FDA-issued guidance. Fontem US plans on submitting additional information to the FDA as the agency reviews its application.
In a press release, Antoine Blonde, president of Fontem US, commented: “We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health. Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”