British American Tobacco (BAT) has announced that its U.S. subsidiary, Reynolds American, has submitted its Premarket Tobacco Application (PMTA) to the U.S. Food and Drug Administration (FDA) requesting the authorisation to market the company’s VUSE vapour product, according to a company press release.

Reynolds has submitted more than 150,000 pages of documentation to support the applications and the meet the FDA’s issued guidance, the press release said. The issued guidance demands manufacturers of vapour products to provide information on the composition, design and manufacturing process associated with the product, as well as chemistry, toxicological and behavioural studies that show that the product is appropriate for the protection of the public health when used, BAT wrote.
“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,” Dr James Figlar, executive vice president of scientific and regulatory affairs at reynolds was quoted as saying. “This is an important first step in a long process for the millions of adult cigarette smokers who may want a legal alternative to combustible cigarettes, thus we look forward working with the agency as the process moves forward.”
CEO of Reynolds Ricardo Oberlander also commented on the PMTA application, saying, “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. We continue to support the FDA’s efforts to create, implement and enforce a science and rule-based regulatory regime to protect the public health. Our regulatory applications, including those submitted for Camel Snus along with other future submissions for products in our Modern Oral Portfolio like VELO, are positioned to transform the market through a range of dynamic alternatives to traditional combustible cigarettes.”
Reynolds is currently awaiting the FDA’s review of the applications to conclude whether the products will be accepted for filing and substantive review. BAT said that Reynolds’ is the first in the US vapour industry to submit a PMTA.