BAT to Challenge FDA's Marketing Denial Order for Flavored Vuse Products

WINSTON-SALEM, N.C. — British American Tobacco (BAT) plans to fight the U.S. Food and Drug Administration's (FDA) decision to end the sale of flavored vapor products from R.J. Reynolds Vapor Co.'s (RJR Vapor) portfolio.

RJR Vapor, based in Winston-Salem, is BAT's U.S. indirect subsidiary.

"According to the FDA, the sole ground for this arbitrary decision was the absence of long-term consumer switching data for these products. This is a capricious decision, considering a year-long data package was presented at the Food & Drug Law Institute Tobacco & Nicotine Regulatory Product Science Symposium on March 30, 2023 with FDA in attendance," said BAT Chief Strategy & Growth Officer Kingsley Wheaton, who added the company will publish a summary of the data on its website.

[Read more: FDA Denies PMTAs for Two Vuse Menthol Products]

His comments followed the FDA's decision to issue Marketing Denial Orders (MDOs) for Vuse Alto's Menthol and Mixed Berry products. The agency is still reviewing RJR Vapor's Vuse Alto Rich Tobacco and Golden Tobacco products.

"This decision flies in the face of proven science and is contrary to the FDA's stated goal of reducing the health effects of tobacco use. This disappointing decision would harm, not benefit, public health. We believe appropriately regulated flavored vaping products — including menthol — are critical in supporting adult smokers migrate from combustible cigarettes," Wheaton said.

RJR Vapor intends to challenge the denials and will seek a stay of enforcement of the Menthol denial immediately.

FDA's Decision

The vapor company submitted premarket tobacco product applications (PMTAs) for Vuse Alto to the FDA in 2020. According to BAT, the applications build on the science submitted in the earlier PMTA submissions to the agency with respect to Vuse Solo, Vuse Vibe and Vuse Ciro, which were granted marketing authorization in original flavors in October 2021 and May 2022, respectively.

However, on Oct. 12, the agency issued MDOs for six flavored vapor products under the Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths. With the MDOs in place, RJR Vapor must not market or distribute these products in the United States or risk FDA enforcement action. The company may submit new applications for these products, according to the agency.

"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, 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 nontobacco-flavored product, we'd authorize the product. But such evidence was lacking in this case."

The FDA has received applications for more than 26 million deemed tobacco products and has made determinations on 99 percent of the applications.