The first and only combustible tobacco cigarette containing minimal to non-addictive levels of nicotine and authorized by the U.S. Food and Drug Administration (FDA) to help adult smokers smoke less is now available through a national pilot exclusively in select Chicagoland Circle K stores.
22nd Century Group, Inc., a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science – developed VLN cigarettes containing 95% less nicotine than conventional cigarettes.
The proprietary tobacco was the subject of 10 years of research and more than 50 government-funded, independent clinical trials. The research was conducted by or for esteemed public health institutions and universities, including: the FDA; the National Institute on Drug Abuse (NIDA); Centers for Disease Control and Prevention (CDC); the National Cancer Institute (NCI); Johns Hopkins University; and Mayo Clinic, to name a few.
The research found:
- A 50% reduction of cigarettes per day (CPD) after 20 weeks
- More smoke-free days and quit attempts
- A reduction in cravings and withdrawal symptoms
As a result of these and other scientific evidence, VLN received the FDA’s first and only modified risk tobacco product (MRTP) authorization granted for a combustible tobacco cigarette. Additionally, the FDA requires each package of VLN to prominently display the evidence based claim “Helps you smoke less.”
“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,” said Mitch Zeller, J.D., former director of the FDA’s Center for Tobacco Products.
Chicago Medical Society President Dr. Tariq Butt, MD, said he and others at the Chicago Medical Society intend to closely review the independent research cited by the FDA.
“As a primary care physician, I’ve lost patients because they were unable to quit smoking,” Dr. Butt said. “We can’t ignore new products that could help people smoke less. If the FDA says this reduced nicotine cigarette will help people smoke less, then as doctors it’s something we need to consider for patients.”
James A. Mish, chief executive officer of 22nd Century Group, said, “Studies show that at least half of all adult smokers try to quit each year, and VLN cigarettes give them an alternative that tastes, smells and burns like a cigarette but greatly reduces their nicotine consumption.”
Michael Zercher, president & chief operating officer of 22nd Century Group, said the company is focused on harm reduction and plant technology/science and not affiliated with the “big tobacco” companies.
“More than 30 million Americans still smoke despite decades-long attempts to migrate smokers to other forms of nicotine delivery, taxing cigarettes, banning public smoking, and numerous education campaigns about the dangers of smoking,” Zercher said. “22nd Century Group is the only company approaching the problem by removing the addictive element from combustible cigarettes, an approach the FDA projects could save 8 million lives by the end of the decade if the nicotine levels of all cigarettes were to be reduced to the levels achieved by VLN.”
In addition to “Helps you smoke less,” the FDA authorized VLN to make the following claims:
- “95% less nicotine.”
- “Helps reduce your nicotine consumption.”
- “…Greatly reduces your nicotine consumption.”
In 2017, the FDA announced a comprehensive plan to limit the level of nicotine in all cigarettes, rendering them minimally addictive or nonaddictive. To be clear, no cigarette is safer even if it contains much less nicotine. VLN must still include Surgeon General’s warnings and FDA-authorized language on its packaging and marketing materials.
“We applaud the FDA on this plan and fully support all cigarettes containing only minimally or non-addictive levels of nicotine,” said Dr. Butt of the Chicago Medical Society.
Chicagoland Circle K Pilot
VLN cigarettes are now available exclusively at more than 150 Circle K convenience stores across Chicagoland. Participating pilot launch stores are located in Chicago, suburban Cook County, and the collar counties.
When choosing Chicagoland for the pilot, 22nd Century noted smokers are found within every segment of the population, many of whom are looking for alternatives. The CDC estimates 15.5% of Illinois adults aged 18 years or older smoke cigarettes, higher than the national average of 12.5%, according to 2018 state and 2020 national statistics.
A pack of VLN cigarettes will be similarly priced to full nicotine premium brands, approximately $9-$12 depending on tax. Illinois is the second most expensive cigarette retail market in the United States.
The three- to six-month pilot will be the first U.S. sales of VLN King and VLN Menthol King cigarettes. 22nd Century is also launching VLN cigarettes in South Korea, its first international market. Following the pilot, 22nd Century and Circle K intend to expand sales nationwide to more than 7,000 stores in 48 states.
On April 4, 2022, the Illinois Attorney General’s Tobacco Enforcement Bureau added 22nd Century Group’s VLN cigarettes to the Illinois Directory of Participating Manufacturers listing. The registration was the final step before 22nd Century could begin distribution.