Reynolds American, a unit of British American Tobacco, submitted its e-cigarette product to the federal government for review ahead of market leader Juul Labs Inc. and NJOY Holdings Inc.
The submission makes Reynolds, the maker of cigarette brands like Newport, Camel and Pall Mall, the first company to confirm it had filed for a U.S. Food and Drug Administration review of its e-cigarettes.
Reynolds American’s filing covers its Vuse e-cigarettes, which delivers nicotine through a cartridge-based vapor system and offers adult smokers a "legal alternative to combustible cigarettes.''
The FDA has given companies a deadline of May 2020 to submit any products they want to keep in stores past that date. That order came on the heels of President Trump’s announcement that U.S. health authorities will act to ban thousands of flavors used in e-cigarettes. The president made the declaration after a reported rise in the use of e-cigarettes by teens, which is a part of a national outbreak of vaping-related illnesses that has surged to about 1,300 cases, and at least 29 deaths. In July, a U.S. District Court judge in Maryland issued an order that requires makers of tobacco products — including e-cigarette makers — to file the applications by May 12, 2020.
"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," Ricardo Oberlander, the CEO of Reynolds, said.
The FDA has issued guidance explaining criteria for Premarket Tobacco Product Application submissions, which make clear that manufacturers must provide information on the composition, design and manufacturing process associated with the product, and the chemistry, toxicological and behavioral studies that demonstrate the product — when used — is appropriate for the protection of the public health.
Reynolds' submission to the FDA includes more than 150,000 pages of documentation to back up their application and meet the health agency’s guidance.
"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," James Figlar, executive vice president of scientific and regulatory affairs at Reynolds. "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 to working with the agency as the process moves forward."
Reynolds now awaits FDA's review of the applications to determine whether they are accepted for filing and substantive review.
The FDA, on Sept. 25, proposed a rule, which will help ensure applications for marketing authorization of e-cigarettes contain information on their potential to harm or benefit public health.
The FDA is preparing to pull all e-cigarettes other than those formulated to taste like tobacco off the market in a move that is intended to curb the rise in teen vaping.
The FDA authorization would allow manufacturers to bring sweet- and fruit-flavored products back on the market with FDA authorization even after the ban goes into effect. Companies have to demonstrate to the agency that the products provide a net benefit to public health, and the submissions must include clinical research and behavioral studies with a comparison of the vaping products to traditional cigarettes, with a look at the potential risk of uptake by young people or nonsmokers.