The idea seems simple enough.
Maintain all smoking rituals: light a cigarette, inhale the smoke, including the nasty stuff that can kill you, and exhale. But eliminate most of the nicotine, the chemical that makes tobacco hard to quit, to help smokers cut back.
It was the Food and Drug Administration Think about that strategy For at least six years as one way to make it easier for smokers to quit smoking, if not to quit smoking completely. Less than two years ago, I licensed the 22nd Century Group, a publicly traded company Biotech Factory Corporation It is based in Buffalo, New York, to advertise its low-nicotine cigarettes as modified-risk tobacco products.
Now, the first authorized cigarettes that contain 95% less nicotine than conventional cigarettes are coming to California, Florida and Texas in early July, after a year of marketing testing in Illinois and Colorado. It’s part of an aggressive 22nd Century rollout that, by year’s end, could bring its products to 18 states—together markets that account for more than half of U.S. cigarette sales.
But anti-smoking groups oppose giving the green light to 22nd century products. Rather, they are Federal regulators urged To expand on their original plan to put Low nicotine standard For all combustible cigarettes to make them less or less addictive. They expect the FDA to take the next step in that industry-wide regulatory process as early as this fall.
“Unless and until there is a category-wide condition that drops nicotine to low, non-addictive levels, this won’t make a difference,” said Erika Sward, a spokeswoman for the American Lung Association.
major tobacco companies AltriaAnd ReynoldsAnd ITG Brands He did not respond to requests for comment.
It is estimated to cause cigarette smoking More than 480,000 deaths a year In the United States, including passive smoking, tobacco use contributes to being the leading preventable cause of death nationwide. In 2018, Scott Gottlieb, then-FDA commissioner, wrote that capping nicotine levels “could lead to more than 8 million tobacco-related deaths by the end of the century—an undeniable public health benefit.”
The FDA has concluded that people will collectively smoke fewer cigarettes and have less exposure to the deadly toxins still found in low-nicotine cigarettes.
22nd Century says it used a patented process to control the biosynthesis of nicotine in the tobacco plant, which enabled it to make a pack of cigarettes that contained nearly as much nicotine as a Marlboro. It generally says that it is usedModern plant breeding techniquesincluding genetic engineering, gene editing, and molecular breeding.
22nd Century Collection
He said a 5% nicotine retention is enough to prevent smokers from seeking more to satisfy their cravings John MillerHead of Smoking in the 22nd Century.
“There’s just enough that your brain thinks it’s getting, but it’s not,” said Miller. “That was really one of the reasons we got to those nicotine levels, because you didn’t have extra smoking.”
Low-nicotine cigarettes can help some smokers quit or stop smoking, perhaps in combination with a nicotine patch or gum, when they’ve tried and failed at other smoking cessation programs, Miller said.
Campaign for Tobacco-Free Kids president Matthew L. Myers supports the development of an industry-wide low-nicotine standard, saying the concept will only work if consumers no longer have an alternative to higher-nicotine cigarettes.
“The concern about a product that is still addictive but provides lower levels of nicotine is, in fact, that consumers will smoke more, because the evidence shows that someone who is addicted will smoke enough to satisfy their cravings,” Myers said.
Both the FDA and Anti-smoking groups Cite studies that find that low levels of nicotine do not lead smokers to smoke more to reach the same levels of nicotine. But those studies assumed smokers wouldn’t get a high-nicotine substitute, researchers and anti-smoking groups said.
Allowing low-nicotine cigarettes while still having conventional cigarettes available could be detrimental to public health if they do not encourage smokers to quit completely or encourage others to start smoking because they believe there is a safe way to try cigarettes, a campaign for tobacco-free children and many health associations wrote in a letter. FDA urged To reverse its decision in the 22nd century.
22nd century cigarettes are still dangerous, and consumers must quit smoking significantly to gain health benefits. But anti-smoking groups fear that many smokers will not understand this.
“If people are looking at this as a magic bullet and still continuing to use tobacco, they are not doing anything to change their risk,” said Soward, of the Lung Association.
Anti-smoking groups are particularly opposed to allowing the 22nd Century to market menthol cigarettes even as the Food and Drug Administration is considering banning such cigarettes nationwide.
FDA spokeswoman Abby Capobianco confirmed that 22nd Century has the only low-nicotine cigarette authorized by the FDA, but she did not respond to requests for comment on the FDA’s plans to regulate nicotine in cigarettes.
Ca already menthol outlaws flavoring, and Miller said the company will not defy that state’s ban and will not sell menthol cigarettes in California.
But Miller hopes the company will eventually win an exemption from any federal ban, in part, he said, because more than half of menthol smokers are likely to switch to traditional cigarettes.
“This is not what the FDA wants to happen,” Miller said. “They need shelter for these menthol smokers and our smoker is obviously a natural.”
The company is expanding into California, Florida and Texas due to the nationwide leading volume Her smokers. He. She Previously announced It also plans to start selling low-nicotine, or VLN, cigarettes this year in Arizona, New Mexico and Utah, and may roll out to 10 more states.
The company is prioritizing seven states that offer tax incentives for products that the FDA has said reduce tobacco risks, believing its cigarettes will have a price advantage over other cigarettes in Colorado, Connecticut, Kentucky, Michigan, North Carolina, New Mexico and Utah. Miller said the company may pressure California lawmakers to add similar incentives as part of the state’s ramped-up effort to discourage smoking, which remains addictive. 10% of its population.
Miller declined to disclose the company’s market share from the two test states, but said sales were above expectations.
“If we can take this to the level of, like, non-alcoholic beer — you know, 3% to 5% category — that’s a game-changer,” Miller said. “We know there is latent market demand for this product.”
This article was produced by KFF Health NewsKaiser Health News (KHN), formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism on health issues and is one of the core operating programs in KFF – The independent source for health policy research, polls and journalism. KFF Health News is publisher California HealthlineIt is an editorially independent service California Health Care Corporation.
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