First Modified-Risk Combustible Cigarette to Launch in Test Market

BUFFALO, N.Y. — The first combustible cigarette authorized to go to market as a modified-risk tobacco product by the Food and Drug Administration (FDA) is preparing to launch in a major market.

Following the FDA's decision in late December, 22nd Century is moving a to bring VLN to market. A pilot launch will begin in its first major metropolitan market by March, with marketing and distribution expected to expand to a full nationwide launch. 

Last month, the agency authorized 22nd Century Group's modified risk tobacco products (MRTP) applications for two cigarettes, VLN King and VLN Menthol King, paving the way for the products to be marketed as reduced risk.

The exposure modification orders specifically authorize the manufacturer to market VLN King and VLN Menthol King with certain reduced exposure claims regarding nicotine, including:

• 95 percent less nicotine
• Helps reduce your nicotine consumption
• Greatly reduces your nicotine consumption

In addition, according to the agency, Buffalo-based 22nd Century must include "helps you smoke less" on product labeling or advertising when using the reduced exposure claim.

"The FDA's MRTP authorization of VLN ushered in a new reality — a combustible cigarette carrying an authorized harm reduction claim supported by extensive scientific and clinical studies, most of which were funded by federal health agencies," said 22nd Century CEO James A. Mish.

"VLN is the only reduced harm product of its kind, and we are confident based on the research that it can absolutely be successful on its own or in combination with other harm reduction products. With an estimated 1,300 deaths per day associated with U.S. smoking, our products that can help people smoke less offer a truly a game-changing prospect for millions of American adults who currently smoke," Mish added.  

With the launch into a pilot market this March, 22nd Century will test and optimize its marketing mix educating smokers about the benefits of reduced nicotine content in VLN King and VLN Menthol King cigarettes.

"22nd Century has secured a well-known national retail partner for VLN's pilot market launch phase," Mish said. "We intend to deploy and test a wide array of marketing materials aimed at adult smokers looking for ways to help them smoke less. These will include marketing at the point of sale, direct materials sent to self-identified adult smokers interested in VLN and online resources such as our new product site at tryvln.com." 

22nd Century is also engaged in ongoing discussions with other potential partners, both retail and strategic, interested in helping to introduce reduced nicotine content products using 22nd Century's proprietary tobacco to adult smokers.