FDA Orders Spectrum Research Cigarettes
The U.S. Food and Drug Administration (FDA) in coordination with the National Institute on Drug Abuse and other organizations, has ordered 3.6 million Spectrum-brand variable nicotine research cigarettes from 22nd Century Group.
The research cigarettes will be used for independent, scientific studies to validate the public health benefits identified by the FDA and others of implementing a national standard requiring all cigarettes to contain minimally or non-addictive levels of nicotine.
“We are proud to partner with public health researchers and look forward to the next step in the FDA’s plan to reduce the nicotine content of all cigarettes sold in the U.S. to minimally or non-addictive levels,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“22nd Century remains the leader in reduced nicotine content tobacco products. We believe when the FDA mandate ultimately goes into effect, we will be well-positioned to capitalize on this tremendous opportunity, and we are committed to licensing our technology to make it possible for every cigarette manufacturer in the U.S. to comply with the standard.”
According to 22nd Century Group, the selection of Spectrum cigarettes is not connected to 22nd Century’s modified risk tobacco application for the company’s reduced nicotine content VLN cigarettes, which feature 95 percent les nicotine than conventional brands.
22nd Century believes that authorization of the company’s MRTP application is imminent, and it plans to launch VLN cigarettes within 90 days of authorization.