Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.
The cigarettes, called VLN King and VLN Menthol King, are the first combustible cigarettes to gain authorization from the FDA as products that can help reduce exposure to, and consumption of, nicotine for smokers. The cigarettes contain 95% less nicotine than traditional cigarettes. They’re made by 22nd Century Group, a New York-based company that produces them by genetically modifying the roots of tobacco plants so that they produce less nicotine.
The FDA is requiring that the company include the phrase “Helps you smoke less,” when advertising the cigarettes as products that can reduce exposure to nicotine — a decision that has drawn criticism from health advocacy groups.
The cigarette packages must also carry conventional warnings about the dangers of any cigarette, such as cancer, heart disease and exposure to carbon monoxide. The special authorization does not mean the products are FDA approved or considered safe. Rather, they’re intended for current smokers, to help them smoke fewer cigarettes. The FDA does not approve cigarettes, but it regulates their manufacture, import, packaging, labeling, advertising, promotion, sale and distribution.
“Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a news release when the cigarettes gained the marketing authorization in December. “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.”
Starting this week, the cigarettes will be in more than 150 Circle K stores in the Chicago area, priced between $9 and $12 a pack, depending on local taxes. The cigarettes will be sold in the Chicago area as part of a 3-to-6-month pilot, after which 22nd Century and Circle K intend to expand sales nationwide to more than 7,000 stores in 48 states.
The company behind the cigarettes chose the Chicago area for its U.S. pilot because it’s one of the biggest metropolitan areas in the country, and because of its diverse population, said John Pritchard, vice president of regulatory science for 22nd Century Group. As part of the special FDA authorization, the company must continue to monitor the products and conduct studies, once they’re on the market.
The company is not affiliated with traditional Big Tobacco companies, but is open to licensing its products, he said.
“We’re excited about what this means for helping adult smokers,” Pritchard said.
The percentage of people who smoke cigarettes in the U.S. has dropped dramatically over the years, from 20.9% of the population in 2005 to 12.5% in 2020, or more than 30 million people, according to the Centers for Disease Control and Prevention. In Illinois, 14.5% of adults smoked cigarettes in 2019. Still, cigarette smoking is responsible for nearly half a million deaths in the U.S. each year, and, in 2015, about 68% of adult cigarette smokers said they wanted to quit.
“Cigarettes of today have two fundamental flaws: One of them is they’re harmful because they’re smoked products, and second is they’re highly addictive because nicotine is delivered at high levels into the lungs,” Pritchard said. A VLN cigarette is “still combusted, it is still smoked, but the public health disaster really comes from a combination of both those fundamental flaws.”
Studies show that using cigarettes with such low nicotine levels likely reduces nicotine dependence, which is expected to lead to less smoking in the long run and, in turn, less exposure to the toxins that lead to illness and death, according to the FDA.
While other products exist to help people smoke less — such as nicotine patches and gums — the VLN cigarettes provide an alternative for people who are attached to the ritual of smoking a cigarette, Pritchard said.
Several Chicago-area experts say the products sound promising, though some prominent groups have criticized the FDA’s decision to allow them to be marketed as products that can help reduce nicotine consumption.
Dr. Tariq Butt, president of the Chicago Medical Society, said though the ultimate goal is for patients not to smoke at all, the VLN cigarettes are something doctors might want to consider as a way to help people smoke less.
And Salahuddin Syed, an addiction psychiatrist at Ascension Alexian Brothers Behavioral Health Hospital in Hoffman Estates, said the products could be useful, especially for people who like the feeling of taking out a cigarette and lighting it.
“I think this could help address that ritual smokers are addicted to,” Syed said. “I think we need all the tools we have to help people decrease exposure to these harmful products.”
Still, he cautioned that he wouldn’t want people to think the VLN cigarettes are safe, nor use the facts that they have less nicotine and gained the special FDA authorization “as an excuse to start smoking or keep smoking.”
Andrea King, who directs the Courage to Quit tobacco cessation program at University of Chicago Medicine, called the cigarettes “a very interesting product.” She said she’s curious to see how well they will work in the real world, given that many smokers are reluctant to switch brands. She also noted that if smokers supplement the VLN cigarettes with their usual cigarettes, that might not lead to as much of a reduction in smoking.
“The problem is we’re not in a vacuum,” King said. “These other products are right there.”
A number of prominent groups, including the American Academy of Pediatrics, the American Lung Association and the American Heart Association have expressed similar concerns. The groups, along with several others, wrote a letter to Zeller at the FDA in early March asking the FDA to revoke its decision on the marketing of the VLN products.
They alleged that the decision exceeded the FDA’s statutory authority, and that what’s needed is an industrywide reduction in nicotine in cigarettes. They wrote that introducing VLN cigarettes “into a marketplace where highly addictive combustible products remain readily available and are widely promoted, yields none of the public health benefits of a product standard and, indeed, will be a public health detriment. The public health benefits of low nicotine products will be realized only through an industrywide mandate; they cannot be achieved on a product-by-product basis.”
The company must request authorization from the FDA to continue the special marketing of the cigarettes after the current order expires in five years. The FDA also may withdraw the current order if it’s no longer expected to benefit the health of the population as a whole, such as if former smokers or young people use the cigarettes, or if there’s a decrease in the number of current smokers who completely switch to VLN cigarettes, according to the FDA.
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