Reynolds Seeks FDA Review of E-Cigarettes

WASHINGTON, D.C.—Tobacco giant Reynolds American has submitted an application to the Food and Drug Administration in an effort to keep its Vuse e-cigarettes on the market. According to the Wall Street Journal, the Reynolds filing, which exceeds 150,000 pages, gives the company a jump on its two main rivals, JUUL and NJOY Holdings. The FDA, which regulates tobacco, has given companies until May 2020 to submit applications for products they want to keep on store shelves after that date.

The submissions must include clinical research and behavioral studies comparing vaping products to traditional cigarettes and examining the potential risk of uptake by young people or nonsmokers.  Currently, the FDA is planning to remove all e-cigarettes from the market, except for those formulated to taste like tobacco, an action aimed at curbing the rise in teen vaping.

The application from Reynolds, the U.S. business unit of British American Tobacco PLC, covers a group of products in its Vuse Solo line of e-cigarettes, including several different flavors, company executives said. The Solo refill pods come in flavors such as melon, chai, mint and berry. The company plans to submit other applications over the next several months. Reynolds has three other Vuse product lines including Alto, a rectangular vaporizer which the company is promoting as a competitor to market leader JUUL.

Meanwhile, JUUL is still conducting clinical trials on its products, including mango, mint and menthol flavors, to gather information that it plans to submit to the FDA by May, said insiders. NJOY, the No. 2 player, plans to submit its application in January. JUUL last year voluntarily stopped selling its sweet and fruit flavors in bricks-and-mortar stores under pressure from regulators.

Reynolds ran its first television ad for Vuse in March and a month later, it put Vuse Alto coupons on packs of Camel Crush cigarettes. Since July, the company has sold deeply discounted Alto devices priced at 99 cents, not including refill pods. The pods come in menthol, mixed berry and tobacco flavors. Vuse, an early entrant to the market, was eclipsed in sales by JUUL, which commands 67% of the U.S. retail market, according to Wells Fargo.

Vuse accounts for 12% of e-cigarette sales, and NJOY 14%. Japan Tobacco, whose Logic e-cigarettes represent 2% of the U.S. market, submitted an application to the FDA in August. This year NJOY has made strong market share gains with a 99-cent promotion on its Ace vaping device. The company decided to wind down the promotion in September after the FDA announced plans to pull most e-cigarettes off the market.