The Food and Drug Administration (FDA) has ordered R.J. Reynolds to stop selling its top-selling Vuse Alto menthol flavored e-cigarettes in the United States. Reynolds immediately vowed to legally challenge the ruling.
On June 23, 2022, the FDA denied R.J. Reynolds’ applications to permanently market its menthol Vuse products, including the popular Vuse Alto. The agency determined the potential public health risks outweighed benefits.
Reynolds’ tobacco flavored products were not included in the FDA decision. However, the menthol ban represents a significant blow to Reynolds’ e-cigarette business and overall financial outlook.
FDA: Menthol Vapes’ Risks Outweigh any Potential Benefits
The FDA is required to ensure new tobacco products provide a net public health benefit, balancing potential upsides for adult smokers against risks like youth addiction.
In the case of Reynolds’ menthol Vuse products, the FDA concluded risks related to youth initiation outweighed potential benefits for adult smokers trying to quit cigarettes.
Menthol e-cigarette varieties have faced heightened FDA scrutiny due to strong evidence they disproportionately appeal to underage users. The agency cited data showing Vuse products are popular among youth and teens.
Reynolds disputed this rationale, claiming the FDA ignored evidence presented on Vuse products’ role in harm reduction for adult smokers. However, the agency maintained the company failed to demonstrate a net public health benefit.
Reynolds Vows Legal Fight to Keep Vuse Menthol Products
British American Tobacco (BAT), the parent company of R.J. Reynolds, vowed to immediately appeal the FDA’s decision in court.
This legal strategy would allow Reynolds to keep selling its menthol Vuse products for the duration of litigation, which could take years to resolve.
Juul and other major e-cigarette makers have similarly used court appeals to prevent removals after FDA marketing denials. BAT called the latest menthol ban ruling “flawed” and claimed it “flies in the face of the scientific evidence.”
Reynolds voluntarily discontinued its Vuse mixed berry flavor, also denied authorization. But the company remains adamant in defending its larger menthol business.
Vuse Alto Menthol is Reynolds’ Top Seller
Losing the ability to sell popular Vuse Alto menthol pods would severely impact Reynolds’ bottom line.
As Reynolds’ highest selling product line, the menthol version accounts for around $1.6 billion in annual U.S. sales. Overall, Vuse e-cigarettes command 40% of the total market.
Reynolds has worked to brand Vuse as a legitimate reduced harm option for adult smokers in an unregulated vape market flooded by youth-friendly disposables and flavored products.
But the FDA’s stance indicates Reynolds’ efforts failed to adequately convince regulators of net public health gains versus potential youth addiction risks.
Is a Total Menthol Cigarette Ban Coming?
The FDA denial of Reynolds’ menthol vapes follows similar rejections of other brands’ flavored products in recent months.
Some public health advocates see this as a potential precursor to a total menthol cigarette ban as well. Banning menthol in combustibles is one of the FDA’s stated policy goals.
Such a move could come later in 2022 or 2023 and would have major implications for Reynolds. Menthol versions account for over one-third of U.S. cigarette sales, led by the company’s Newport brand.
Newports alone generate over $7 billion annually for Reynolds. Losing menthol would erase the majority of the company’s cigarette profits.
What’s Next for E-Cigarette Regulation?
Reynolds’ court appeal aims to buy time as the FDA continues ruling on millions of vaping product applications. The agency is expected to issue decisions on all submissions by September 9, 2022.
Some experts believe the FDA is only authorizing e-cigarettes replicating the flavor profile of combustible cigarettes. All other flavors are deemed too appealing to youth.
But Reynolds argues allowing obviously youth-friendly flavors like “Cotton Candy” and failing to punish “bad actors” undermines any rationale for banning Vuse menthol.
The coming months will determine the contours of the permitted U.S. e-cigarette market as regulation and court battles continue shaping the vaping landscape.
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