FDA Gives Marketing Green Light to Seven Vuse Vapor Products
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway.
[Read more: FDA Plans to Improve Portal for New Tobacco Product Applications]
Marketing orders were granted to R.J. Reynolds Vapor Co. for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods — consisting of three Vuse Alto Pod Golden and three Vuse Alto Pod Rich varieties — which are sealed, prefilled, and nonrefillable.
R. J. Reynolds Vapor Co. is a U.S. indirect subsidiary of British American Tobacco (BAT).
"We welcome the FDA's decision to authorize RJR Vapor's Vuse Alto device, as well as Golden Tobacco and Rich Tobacco flavors. With authorizations for Alto, Vibe, Ciro and Solo, all in tobacco flavors, BAT now has the largest portfolio of vapor market authorizations provided to any U.S. organization for premarket tobacco product applications," said Tadeu Marroco, Chief Executive, BAT.
"However, the success of these legal products is dependent on the FDA doing more to tackle a thriving illicit marketplace of vapor products, which are intentionally and systematically marketed to youth," Marroco added. "By creating a future where a wide range of potentially reduced-risk products is accessible to adult smokers, we are taking a meaningful step towards building a smokeless world."
While the FDA is authorizing the marketing of these tobacco products in the U.S., the agency does not consider the products safe or “FDA approved.” Additionally, this action is not an authorization or indication of appropriateness to market these products as modified risk tobacco products, according to the agency.
The FDA evaluates PMTAs based on a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole. After reviewing the company's applications, the agency determined there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of public health.
To date, the FDA has authorized 34 e-cigarette products and devices, including the seven new Vuse products,. In June, the agency granted marketing orders for its first menthol flavor vaping products, giving NJOY LLC authorization to begin marketing four menthol-flavored e-cigarettes in the U.S.
R.J. Reynolds is still awaiting approval for its Vuse Pro age-gated device, an electronic nicotine delivery system device platform which connects to a mobile application that verifies the consumer's age through a third-party provider prior to unlocking for use. Due to the FDA's continued concern over the use of tobacco by underage smokers, the company hopes the security features on the device will meet regulatory approval, as Convenience Store News previously reported.
Those seeking a list of tobacco products — including e-cigarettes — that may be legally marketed in the U.S., can visit FDA’s new Searchable Tobacco Products Database.
Winston-Salem, N.C.-based Reynolds American is the U.S. parent company of R.J. Reynolds, Santa Fe Natural Tobacco Co. Inc., American Snuff Co., R.J. Reynolds Vapor and Modoral Brands Inc.