22nd Century Wins FDA Nod to Promote Low-Nicotine Cigarettes
(Bloomberg) -- 22nd Century Group Inc. received regulatory authorization to start advertising its cigarettes as low in nicotine -- a move that could shake up the shrinking tobacco market.
The company’s shares surged after the Food and Drug Administration announced the decision on Thursday. The agency authorized the marketing of both VLN King and VLN Menthol-brand products. The company, which was already allowed to sell the products, now can market them as having 95% less nicotine than conventional ones.
“We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” Mitch Zeller, director of the FDA’s Center for Tobacco Products said in a statement announcing the decision.
The approval may have an impact on the broader market, with the agency also eventually expected to weigh in on the issue of whether all cigarette makers must reduce nicotine content in their products. Tobacco companies’ argument that removing nicotine isn’t possible have held less water with regulators now that the Williamsville, New York-based company has shown it can be done.
22nd Century Group has for years made Spectrum cigarettes, a brand with varying levels of nicotine that have been used for government-funded research on tobacco and addiction. It made its case to the FDA more than a year ago on why it should be able to sell low-nicotine cigarettes to the public, saying they might be marketed to help wean adult smokers off of addictive nicotine.
“This helps us fulfill a mission to reduce the harm caused by smoking. It will help Americans to reduce the tragic toll of tobacco,” John Pritchard, the company’s vice president of regulatory science, said in a phone interview about the company’s intent months ahead of the agency’s actual approval.
The FDA’s decision comes as big tobacco companies such as Altria Group Inc., Philip Morris International and British American Tobacco Plc try to replace their cigarettes with “reduced risk” products that deliver nicotine in other formats, like vape or oral products.
None of them have made a low-nicotine cigarette, however, and after the FDA declared in 2018 that it intended to set rules on nicotine levels in cigarettes, Altria had said it wasn’t clear that was “technically achievable” or would help reduce smoking.
22nd Century shares jumped as much as 17% Thursday in New York, the biggest intraday gain since August.
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