FILE PHOTO: People walk past the British American Tobacco offices in London, Britain October 21, 2016. REUTERS/Stefan Wermuth
(Reuters) – British American Tobacco Plc unit Reynolds American Inc on Friday became the first major company to confirm it had filed for a U.S. Food and Drug Administration review of its e-cigarette product, ahead of market leader Juul Labs Inc.
Reynolds American said its Vuse e-cigarette delivers nicotine via a cartridge-based vapor system and seeks to offer adult smokers a “legal alternative to combustible cigarettes”.
The company said it had provided the health regulator with over 150,000 pages of documentation, including information on the composition, design and manufacturing process associated with its product, as well as safety data.
A rise in teen use of e-cigarettes, and a national outbreak of a mysterious lung illness linked to vaping that has claimed at least 29 lives, have spurred regulators into exploring ways to police the manufacturing and marketing of these products.
To regulate the industry, the FDA last month proposed a rule, which, when finalized, will help ensure applications for marketing authorization of e-cigarettes contain information on their potential to harm or benefit public health.
A U.S. District Court judge in Maryland in July issued an order that would require makers of tobacco products, including e-cigarette makers, to file the applications by May 12, 2020.
The Trump administration in September also outlined plans to remove all flavored e-cigarettes from store shelves, pointing the finger at sweet flavors that had drawn millions of children into nicotine addiction.
Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel