Imperial Brands subsidiary Fontem US LLC (Fontem US) today announced that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its myblu electronic vaping products.
Fontem US’s blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products.
The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
Fontem US believes the evidence provided shows that blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA. Fontem US now awaits the FDA’s review of the applications and will provide additional information sought by the agency as part of the PMTA process.
“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,” said Antoine Blonde, president of Fontem US. “Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
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