22nd Century Group said that it is fully prepared to partner with the U.S. Food and Drug Administration (FDA) to launch its VLN reduced nicotine content cigarette brand and license its reduced nicotine content tobacco technology to every cigarette manufacturer.
Recent media reports suggest that the Biden administration is actively considering moving forward the Advance Notice of Proposed Rulemaking (ANPRM) that will require tobacco manufacturers to reduce the amount of nicotine in all combustible cigarettes sold in the United States to be “minimally or nonaddictive.”
“A nicotine cap by the FDA has been in the works since the Obama administration,” said James A. Mish, CEO of 22nd Century Group, in a statement. “During that time, 22nd Century has consistently proven beyond any doubt with our VLN cigarettes that a cigarette that contains nicotine levels that the FDA has identified as ‘minimally or nonaddictive’ is technically feasible. Moreover, given the millions of Americans who smoke and will suffer and die from cigarette addiction, this mandate is necessary and appropriate.”
“As the only company with the ability to offer a combustible tobacco product that can meet the FDA’s mandate today, we look forward to helping with this critical public health initiative.
“Numerous independent research studies—largely funded by U.S. government agencies—have consistently confirmed the benefits of implementing a mandate on reduced nicotine content cigarettes for adult smokers.
“Once this rule is in place, we are fully prepared to provide the solution by making our VLN cigarettes available to adult smokers, and we remain willing to license our technology to every cigarette manufacturer in the industry to give them the opportunity to join us in our efforts to reduce the harm caused by smoking and to protect future generations from ever becoming addicted to cigarettes.”
The ANPRM that President Biden’s administration is considering moving forward was issued in March of 2018, and the comment period closed in June of 2018. The FDA will likely issue a notice of proposed rulemaking as the next step in the rulemaking process before a final rule is published.
Made from proprietary tobacco engineered to contain 95 percent less nicotine than conventional cigarette tobacco, 22nd Century’s RNC cigarettes are the only combustible tobacco products able to meet the nicotine levels proposed in the FDA’s ANPRM for a tobacco product standard to reduce the nicotine content of all combustible cigarettes, according to 22nd Century.
The company believes that it is in the final stages of the FDA’s application process to obtain a modified-risk tobacco product designation for its reduced nicotine content cigarettes, VLN King and VLN Menthol King. The designation will allow 22nd Century to communicate key features of the products, including the claim “95 percent less nicotine.”