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Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics.
22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive.
Though the details of Dr. Hatsukami’s phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study’s core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that “an immediate approach [to nicotine reduction] is most likely to lead to less harm.” Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a “greater likelihood of more rapid smoking cessation” with the immediate approach to nicotine reduction.
Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins, Director of the University of Vermont Tobacco Center of Regulatory Science took the podium and announced to the conference attendees: “I will present evidence that reducing nicotine content lowers the addiction potential of smoking among those with psychiatric conditions or socioeconomic disadvantage consistent with prior evidence in samples from the general adult smoker population.” In addition to finding reduced evidence of addiction in smokers of 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr. Higgins found that: “VLNCs did not produce evidence of compensatory smoking.” [emphasis added]
Dr. Jonathan Foulds of Penn State College of Medicine also delivered a powerful call to action at the conference, challenging the attending scientists to deny the tobacco industry any diversions or strategies that could be used to delay the FDA’s planned mandate to reduce nicotine in cigarettes to very low, non-addictive levels. Dr. Foulds then pointed out the stakes involved: “Such a move [by FDA to reduce nicotine content of cigarettes] could result in one of the largest single improvements in public health ever [seen] in this country.”
“Considering the results of numerous phase II and phase III studies that have been conducted with VLN cigarettes, there is now compelling and conclusive evidence that Very Low Nicotine cigarettes decrease cigarette dependence, reduce the number of cigarettes smoked per day, and increase smokers’ quit attempts,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “With the power to save millions of lives and to prevent a new generation of young people from becoming dependent on tobacco, minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy.”