A Clarence cigarette manufacturer, 22nd Century Group, is asking federal regulators for permission to tout one of its cigarette brands for their very low nicotine content.
The application to the U.S., Food and Drug Administration is part of 22nd Century’s push to bring its very-low nicotine cigarettes to market and highlight how smokers who use them can reduce their exposure to the nicotine that makes smoking so hard to quit.
22nd Century Group has developed technology to manipulate the level of nicotine in tobacco, and company executives said Monday its low-nicotine cigarettes could contain as much as 97 percent less nicotine as many major brands.
The application the company filed with the FDA seeks permission to include on their packaging a claim that its cigarettes can reduce a smoker’s exposure to nicotine.
A study published last fall in the New England Journal of Medicine that used 22nd Century’s reduced nicotine cigarettes, offered hope that a trick proposed two decades ago – scaling back the nicotine that smokers get from their cigarettes – might help many quit, and steer others toward less dangerous means of feeding their addiction.
The research also offered reassurance that smokers restricted to very low nicotine cigarettes will not simply smoke more, or inhale more deeply, to get the same dosage of nicotine.
“The public health implications of a virtually nicotine-free tobacco cigarette are enormous,” said Henry Sicignano III, 22nd Century’s president and CEO. “The mission of 22nd Century is to reduce the harm caused by smoking.”
22nd Century already has sold more than 17 million of its low-nicotine cigarettes for use in smoking cessation research, including a deal it signed in September to sell 5 million of its low-nicotine cigarettes to the U.S. government, which then provides the cigarettes to researchers studying the effects of smoking. The low-nicotine cigarettes are not sold to consumers.
The company, which lost $8.2 million during the first nine months of last year on $5.6 million in sales as it ramped up production at its North Carolina factory, is hoping to find even broader commercial uses for its low-nicotine cigarettes, which can be manipulated to have varying levels of nicotine.
One potential use is as a prescription-based smoking cessation product.