22nd Century Group plans to commercialize its VLN cigarette plan within 90 days of receiving a modified-risk tobacco product (MRTP) application.
In a letter to shareholders, group CEO James A. Mish expressed optimism that the company’s VLN brand, which contains 95 percent less nicotine than other leading cigarette brands, would be granted MRTP status by the U.S. Food and Drug Administration (FDA).
In March 2018, the FDA issued “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” an advance notice of proposed rulemaking seeking public comment for consideration in developing a potential nicotine product standard.
“We now believe it is not a matter of if but when our application will be granted, and we believe we are months, not years, away from securing our MRTP designation,” wrote Mish.
Mish suggested that an MRTP would greatly boost 22nd Century’s market value.
“Having the only combustible cigarette with a modified exposure claim authorized by the FDA […], could serve as a catalyst for 22nd Century’s commercial sales as even achieving just one-quarter of 1 percent—0.25 percent—market share of the U.S. tobacco market could result in revenues that may over time, based on current market multiples, drive the company’s market capitalization more than five to 10 times higher than it is today,” he said.
“In addition, FDA authorizing the marketing of 22nd Century’s modified risk tobacco products with modified exposure claims would open multiple licensing opportunities for 22nd Century’s proprietary reduced nicotine content tobacco to accelerate the commercial and public health potential.”