Davie cigarette maker has role in low-nicotine study
By Richard Craver Winston-Salem Journal | Posted 2 days ago
A biotechnology company with a Mocksville operation, 22nd Century Group Inc., said Friday its low-nicotine traditional cigarettes were used in a high-profile research study published in the New England Journal of Medicine
22nd Century, based in Clarence, N.Y., opened operations in Mocksville in 2014 through acquiring the production equipment used by defunct Renegade Tobacco Inc.
Its Goodrich Tobacco Co. subsidiary makes Spectrum at the plant, as well as Red Sun and Magic super-premium brands. Spectrum cigarettes are produced from proprietary and patented technology for exclusive use in clinical research.
The low-nicotine study was conducted by the University of Wisconsin’s Center for Tobacco Research and Intervention. Funding by the Center for Tobacco Products of the Food and Drug Administration and by the National Institute on Drug Abuse included providing the cigarette sticks.
The research journal report was released Wednesday.
Other agencies involved in Spectrum research include the National Cancer Institute and the Centers for Disease Control and Prevention. Goodrich announced Sept. 18 it had received an order for nearly 5 million cigarette sticks, raising the overall order total to more than 22 million sticks.
Jesse Moore, a contract spokesman for 22nd Century, said the company wasn’t aware that researchers used Spectrum cigarettes. Researchers did not identify the maker of the cigarettes.
“The company was not alerted; we found out by digging into it,” Moore said.
22nd Century’s goal is “to become the first company in the world authorized by the FDA to market reduced exposure combustible cigarettes.” The company has a licensing agreement with British American Tobacco Ltd., which owns 42 percent of Reynolds American Inc.
22nd Century said the study featured six of the 24 cigarette styles it produces in Mocksville. The styles ranged in nicotine content from 15.8 milligrams per gram of tobacco — comparable with traditional commercial brands — to as low as 0.4 milligrams per gram.
The study featured 800 participants who has been smoking five or more cigarettes a day and had no interest in quitting. They were assigned to smoke either their usual brand or one of six experimental types.
The highlight of the research was that smokers who switched to low-nicotine cigarettes had reductions in nicotine exposure, numbers of cigarettes smoked and nicotine dependence.
“They attempted to quit smoking at a rate (35 percent to 17 percent) double that of participants smoking standard-strength cigarettes” as measured in a 30-day follow-up after the completion of the six-week study.
The Tobacco Control Act of 2009 allows the FDA to mandate lower nicotine levels for traditional cigarettes if it would help public health.
Mandating low-nicotine traditional cigarettes “could potentially end the epidemic of smoking-caused illness and death in the United States,” said Michael Fiore, director of the Wisconsin tobacco research center.
“Reducing the nicotine content of combustible tobacco below addictive levels is an important way to start.”
Although lowering nicotine levels in cigarettes “shows promise, it’s not without risk,” Fiore said. He cited as an example the potential for low-nicotine cigarettes to serve as a gateway to smokeless tobacco, electronic cigarettes or vaporizers.
“Even so, this type of a shift might confer a net health benefit, since such products are likely less harmful than combustible tobacco,” the researchers said.
22nd Century said its cigarettes are being used in a Phase III clinical study that follows 1,250 smokers for five months.
Mitch Zeller, director of the FDA’s tobacco center, said in a statement he could not comment specifically on the study. He said the agency is interested in answers “to the important questions being raised about the role nicotine plays in addiction to tobacco products.
“The FDA knows that, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health.”
The Associated Press contributed to this article.
rcraver@wsjournal.com (336) 727-7376 @rcraverWSJ
The Associated Press contributed to this article
rcraver@wsjournal.com
(336) 727-7376
@rcraverWSJ
