FDA denies marketing of six flavored Vuse Alto e-cigarette products

The U.S. Food and Drug Administration confirmed the issuance of marketing denial orders to R.J. Reynolds Vapor Company for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths. The company must not market or distribute these products in the United States or they risk FDA enforcement action, the FDA said in a statement, adding that the company may submit new applications for the products that are subject to these MDOs. The FDA evaluates premarket tobacco product applications based on a public health standard that considers the risks and benefits of the product to the population as a whole. After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health. “We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, Ph.D., director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.” R.J. Reynolds is an independent U.S. subsidiary of British American Tobacco Group (BTI). Other publicly traded companies in the tobacco products space include Altria Group (MO), Imperial Brands (IMBBY) and Philip Morris (PM).