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These cigarettes may help adult smokers ‘smoke less.’ Now they have FDA authorization

The Food and Drug Administration authorized certain cigarettes that have 95% less nicotine and can help smokers addicted to tobacco products, the agency said.
The Food and Drug Administration authorized certain cigarettes that have 95% less nicotine and can help smokers addicted to tobacco products, the agency said. 22nd Century Group Inc.

These special cigarettes may help adult smokers to “smoke less” and now they’ve gotten authorization from the Food and Drug Administration.

The cigarettes contain 95% less nicotine, which is the highly addictive substance in tobacco products, and they’ll say “helps you smoke less” on the product label.

Although the products aren’t fully FDA approved — as the agency says “there are no safe tobacco products” — 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” cigarettes have received authorization for marketing, the agency said in a Dec. 23 news release.

These combustible cigarettes – meaning they require burning to smoke – are the first to be authorized as a modified risk tobacco product (MRTP) by the federal agency.

“Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers,” the FDA said in a statement.

“If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

The cigarettes are the second tobacco product to receive “exposure modification” orders, according to the FDA, which “allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.”

Despite significantly less nicotine than the average cigarette, 22nd Century says the cigarettes smoke, taste and smell like a “conventional” one, according to a Dec. 23 news release.

“The FDA’s decision to require the additional headline claim ‘Helps You Smoke Less’ alongside our requested headline claim of ‘95% Less Nicotine’ gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN,” James A. Mish, the company’s chief executive officer, said in a statement.

The director of the FDA’s Center for Tobacco products said “the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes.”

The agency said it considered the legal status of menthol cigarettes and available science that showed “these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day” when making its decision, the release said.

The authorization led to a spike in the company’s stock market value, according to Bloomberg.

For those who don’t currently smoke tobacco products, the FDA still advises against using these low-nicotine cigarettes as well as all tobacco products in general.

Using tobacco is the top preventable cause of disease and death in the U.S., according to the FDA.

Tobacco use is a result of more than 480,000 deaths annually, the agency warns.

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This story was originally published December 23, 2021 at 4:59 PM with the headline "These cigarettes may help adult smokers ‘smoke less.’ Now they have FDA authorization."

Julia Marnin
McClatchy DC
Julia Marnin covers courts for McClatchy News, writing about criminal and civil affairs, including cases involving policing, corrections, civil liberties, fraud, and abuses of power. As a reporter on McClatchy’s National Real-Time Team, she’s also covered the COVID-19 pandemic and a variety of other topics since joining in 2021, following a fellowship with Newsweek. Born in Biloxi, Mississippi, she was raised in South Jersey and is now based in New York State.
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