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08/11/2022

Modified-Risk Combustible Cigarette to Test in Second Market

VLN cigarettes first launched in select Chicago-area Circle K stores in April.
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22nd Century VLN King and VLN Menthol King cigarettes

BUFFALO, N.Y. — 22nd Century Group Inc. is planning to bring its lower-nicotine cigarette to a new market next month.

On Aug. 9, CEO James A. Mish said the company will launch its VLN brand in Colorado in September — ahead of schedule. VLN cigarettes first launched in select Chicago-area Circle K stores in April.

"Our VLN pilot in Chicago is exceeding expectations, driving us to accelerate and expand our launch plans. The pilot and consumer studies have made clear that our approach focusing on awareness, education and trial is working with adult smokers," Mish said.

The company is now testing specific offers designed to increase trial and repeat purchase among existing smokers while also expanding its presence in Chicago and Illinois.

"We are also expanding our VLN launch to the state of Colorado ahead of plan. Colorado offers a reduced taxation rate for MRTP authorized products, providing a favorable cost structure for our VLN products in that state as compared to traditional premium cigarettes," Mish said.

"Additionally, and more importantly, we are working closely with a major consumer packaged goods (CPG) distributor and a long-standing specialty distributor covering convenience, grocery, and drug stores across the state, giving us full access to a broad range of more than 3,000 targeted statewide potential points of sale," he said.

According to the company, it is also in advanced discussions with additional channel partners to expand the geographic and regional sales reach of VLN. To date, 22nd Century Group secured the regulatory authorizations to sell VLN in 40 states and Washington, D.C., an increase from nine states in the first quarter.

Applications are pending in all remaining states, the company added.

In December, the Food and Drug Administration (FDA) 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, as Convenience Store News reported.

It was the first time the agency authorized a combustible cigarette go to market as a modified-risk tobacco product.

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.

On Aug. 1, 22nd Century Group submitted public comments in support of a tobacco product standard for menthol in cigarettes. The FDA's proposed menthol cigarette ban could leave VLN Menthol King as the only combustible menthol cigarette on the market, the company noted.

22nd Century is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science. 

The proprietary tobacco was the subject of 10 years of research and more than 50 government-funded, independent clinical trials. The research was conducted by public health institutions and universities, including: the FDA; the National Institute on Drug Abuse; Centers for Disease Control and Prevention; the National Cancer Institute; Johns Hopkins University; and Mayo Clinic, to name a few.