FDA Takes Action to Ban Sales of Vuse Menthol Vapes | ET REALITY


The Food and Drug Administration ordered RJ Reynolds to stop selling its popular Vuse Alto menthol e-cigarettes, a decision Reynolds immediately said he would challenge in court.

On Thursday, the agency denied requests by Reynolds to permanently keep its best-selling menthol products on the market, saying the company did not meet federal standards requiring e-cigarettes to provide more of a health benefit than a risk. In the case of Vuse vaporizers, the FDA said the risks of attracting young people to popular menthol and flavored products outweighed the potential of helping traditional smokers quit.

The decision does not apply to the company’s flavored tobacco products.

Some public health experts have seen the federal agency’s most recent rejections of menthol e-cigarettes as an indication that the agency is more strictly limiting menthol products. The FDA, perhaps by the end of this year, is expected to move toward banning all menthol cigarettes, including Newports, one of Reynolds’ best-sellers with $7.5 billion in annual sales, according to Goldman Sachs research.

British American Tobacco, the parent company of RJ Reynolds, said in a statement that the FDA’s latest ruling “goes against 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 appealing similar agency decisions have been allowed to keep their vaping products on shelves during the litigation.

If the FDA were successful in court against Reynolds, the company would take a severe financial hit. Market data analyzed by Goldman Sachs indicates that the menthol variety is the best-selling of Vuse products, and those menthol vaporizers account for about 29 percent of the US e-cigarette market, accounting for $1.6 billion in sales. Overall, Vuse products, including tobacco-flavored products, account for 40 percent of the market.

The FDA has had the authority to determine the sale of e-cigarettes since 2016. It has denied millions of requests, either for the products to remain on the market or for the sale of new vaping devices. The agency has committed to deciding each application by the end of this year.

Anti-tobacco groups and others have urged the FDA to more tightly regulate the e-cigarette market, noting that a recent survey of middle and high school students showed that Vuse vaporizers were a popular choice among those who used e-cigarettes.

Reynolds has tried to present its products to regulators as legitimate alternatives for adults in an e-cigarette space flooded with illicit products. The company voluntarily offered to stop selling its mixed berry flavor, which the FDA also denied marketing authorization on Thursday.

“Fundamental to the effectiveness of any regulated market is the rule of law, where good behavior is encouraged and bad behavior is punished,” Kingsley Wheaton, an executive at British American Tobacco, said in the company’s statement. “We also remain deeply concerned that the FDA continues to allow the proliferation of youth-appealing vapor products, such as cotton candy and peanut butter cookies, that are flooding U.S. retail shelves. “Companies that openly defy the agency must be held accountable.”

But Reynolds challenges other restrictions. He has filed a lawsuit in California against the state’s new ban on flavored tobacco, after the state the attorney general warned the company and another about the marketing of products that were said to taste “refreshing.”

Yolonda Richardson, president of the Campaign for Tobacco-Free Kids, applauded the FDA’s decision on Vuse, saying it was “one of the strongest actions the FDA has taken to remove illegally flavored e-cigarettes from the market and is a necessary step toward ending the e-cigarette crisis among youth in the United States.”

Alex Liber, an assistant professor at Georgetown University and tobacco control policy researcher, recently worked on a paper linking flavored vape bans to an increase in cigarette sales.

He said the FDA appeared to be on track to authorize only vaporizers that taste like cigarettes. The agency has rejected other menthol e-cigarette applications, deeming them too appealing to teens to outweigh the benefit to adults.

“Whatever that bar and the evidence is, I don’t think anyone has met it,” Dr. Liber said. “I don’t know if the FDA knows what it looks like. “I don’t know what that would be.”

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