PMTA filed for Vuse

Reynolds American Inc. (RAI) on Oct. 11 submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) seeking permission to market its Vuse vapor products.

RAI is among the first in the vapor industry to file a PMTA, according to its parent company, British American Tobacco (BAT). To remain on the U.S. market, all vapor products must be submitted for FDA review by May 11, 2020.

RAI’s submission includes more than 150,000 pages of documentation intended to demonstrate that the continued marketing of Vuse is “appropriate for the protection of the public health,” as required by the FDA.

“Today’s application marks the culmination of years of hard work across multiple teams involving more than 100 individuals, including dozens of Ph.D. team members collaborating every day, with a substantial financial investment,” said James Figlar, executive vice president of scientific and regulatory affairs at RAI.

“We have long worked to build a broad portfolio of competitive options for the adult tobacco consumer, and today’s application is a strong next step for us in that journey,” said Ricardo Oberlander, CEO of RAI.

RAI previously submitted a regulatory application for Camel Snus. The company intends to submit additional applications for products in its “new oral” portfolio, such as Velo.