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Reynolds American files for FDA review of e-cigarette

FILE PHOTO: A man holds an electronic cigarette as he vapes at a Vape Shop in Monterrey, Mexico February 1, 2019. FREUTERS/Daniel Becerril/File Photo

(Reuters) – British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a review of its Vuse e-cigarettes by the U.S. Food and Drug administration, giving it a lead over its main rival Juul Labs Inc.

The FDA has set a May 2020 deadline for e-cigarette makers to submit a formal application to keep their products on the market amid its efforts to curb the use of e-cigarette among teens.

Reynolds, whose Vuse e-cigarettes deliver nicotine via a cartridge-based vapor system, 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.

The company said it had also worked with a team of more than 100 people to prepare the filing, including multiple regulatory experts and scientists.

U.S. regulators are exploring ways to monitor the manufacturing and marketing of e-cigarettes following a rise in use of these products among teens, and a recent outbreak of a mysterious lung illness linked to vaping that has claimed at least 29 lives.

Vaping devices such as Juul’s, which vaporize liquid containing nicotine, have borne the brunt of the regulatory crackdown globally.

The Trump administration also outlined plans in September 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 and Nivedita Balu in Bengaluru; Editing by Maju Samuel and Anil D’Silva

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