The Food and Drug Administration has ordered R.J. Reynolds to stop selling its popular Vuse Alto menthol e-cigarettes, a decision Reynolds immediately said it would challenge in court.
On Thursday, the agency denied applications by Reynolds to keep its top-selling menthol products permanently on the market, saying that the company did not meet the federal standards that require the e-cigarettes to provide more of a health benefit than a risk. In the case of the Vuse vapes, the F.D.A. said the risks of attracting young people to the popular menthol and flavored products outweighed the potential for helping traditional smokers quit.
The decision does not apply to the company’s tobacco-flavored products.
Some public health experts have viewed the federal agency’s most recent rejections of menthol e-cigarettes as an indication that the agency is more strictly limiting menthol products. The F.D.A. is expected, perhaps by the end of this year, to move toward outlawing all menthol cigarettes, including Newports, a top seller for Reynolds with $7.5 billion in annual sales, according to Goldman Sachs research.
British American Tobacco, the parent company of R.J. Reynolds, said in a statement that the F.D.A.’s latest ruling “flies in the face of proven science.” The company said it would fight the decision in court, which could allow Reynolds to keep the disputed Vuse products on the market indefinitely.
Juul and other e-cigarette makers that are appealing similar agency decisions have been permitted to keep their vaping products on the shelves during litigation.
If the F.D.A. were to succeed in court against Reynolds, the company would be dealt a severe financial blow. Market data analyzed by Goldman Sachs indicates that the menthol variety is the top seller of Vuse products, and those menthol vapes make up about 29 percent of the U.S. e-cigarette market, representing $1.6 billion in sales. Overall, Vuse products, including tobacco-flavored products, comprise 40 percent of the market.
The F.D.A. has had the authority to determine the sale of e-cigarettes since 2016. It has denied millions of applications either for products to stay on the market or for the sale of new vaping devices. The agency has pledged to decide every application by the end of this year.
Antismoking groups and others have urged the F.D.A. to more tightly regulate the e-cigarette market, and noted that a recent survey of middle and high school students showed that Vuse vapes were a popular choice among those who used e-cigarettes.
Reynolds has tried to position its products to regulators as legitimate alternatives for adults in an e-cigarette space flooded with illicit products. The company volunteered to stop selling its mixed berry flavor, which was also denied marketing authorization by the F.D.A. on Thursday.
“Central to the efficacy of any regulated market is the rule of law — where good behavior is encouraged, and bad behavior punished,” Kingsley Wheaton, a British American Tobacco executive, said in the company’s statement. “We also remain deeply concerned that the F.D.A. continues to allow the proliferation of youth-appealing vapor products like Cotton Candy and Peanut Butter Cookie, which are flooding U.S. retail shelves. Companies in open defiance of the agency must be held accountable.”
But Reynolds is contesting other restrictions. It has filed suit in California against the state’s new ban on flavored tobacco, after the state attorney general warned the company and another about marketing products that were said to have a “cooling” flavor.
Yolonda Richardson, president of the Campaign for Tobacco-Free Kids, applauded the F.D.A.’s decision on Vuse, saying it was “one of the strongest actions the F.D.A. has taken to rid the market of illegal, flavored e-cigarettes and is a necessary step toward ending the youth e-cigarette crisis in the United States.”
Alex Liber, a Georgetown University assistant professor and tobacco control policy researcher, recently worked on a paper linking flavored-vape bans to an increase in cigarette sales.
He said the F.D.A. appeared to be on a path of authorizing only vapes that taste like a cigarette. The agency has rejected other menthol e-cigarette applications, deeming them too alluring to adolescents to outweigh the benefit to adults.
“Whatever that bar and evidence is, I don’t think anyone has hit it,” Dr. Liber said. “I don’t know if F.D.A. knows what it looks like. I don’t know what that would be.”
