October 11, 2019 / 5:08 PM / a month ago

REFILE-Reynolds American files for FDA review of e-cigarette

(Corrects to “Reynolds” from “Reynold” in the headline)

Oct 11 (Reuters) - British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a U.S. Food and Drug Administration review of its VUSE e-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.

To regulate vape makers, the FDA last month proposed a rule, which, when finalized, will help ensure applications for marketing authorization of their products 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. (Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)

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