22nd Century Group Welcomes Dr. Robert Califf's Confirmation As FDA Commissioner

22nd Century Group, Inc. XXII an agricultural biotechnology company focused on tobacco harm reduction, congratulated Dr. Robert Califf on his confirmation as FDA Commissioner of the Food and Drug Administration (FDA). Califf is known to be a longtime proponent of innovative tobacco control programs and a strong supporter of the agency’s comprehensive plan for tobacco and nicotine regulation.

“Cigarette smoking kills nearly half a million Americans every year. With Dr. Califf’s background, we are confident he will use the power the FDA was given by the 2009 tobacco control act to protect and improve public health by introducing regulations that will help smokers break their addiction to cigarettes,” stated James A. Mish, chief executive officer of 22nd Century Group. “The FDA has already taken great strides to improve public health by granting 22nd Century MRTP authorization for our VLN cigarettes and by announcing that they are on track with the rulemaking process that could ban menthol in cigarettes. It is crucial that the FDA now accelerate implementation of its comprehensive plan to reduce the amount of nicotine allowed in combustible cigarettes to levels that render them ‘minimally or non-addictive.’ Our VLN reduced nicotine content cigarette – the only combustible that FDA has ever granted modified risk orders to – is the only cigarette that meets the nicotine levels proposed in FDA’s nicotine mandate, and we stand ready to support the Agency on this critical public health initiative.”

Senator Richard Burr of North Carolina echoed these concerns during Califf’s December nomination hearing, stating: “More than a decade after receiving authority from Congress, FDA just recently issued the foundational rules to provide a regulatory roadmap for new, and potentially less harmful, tobacco products. CTP is charged with the regulation of tobacco products, which includes a mission to regulate these products for the protection of public health.”

22nd Century noted that the FDA’s reduced harm commitment and rule-making process could leave VLN Menthol King as the only menthol cigarette on the market due to its 95% reduction in nicotine.

By providing a non-addictive menthol option, 22nd Century believes thge FDA’s policy can better help menthol smokers move away from addictive nicotine products altogether rather than merely transitioning them to another addictive nicotine product.

According to the 22nd Century Group, VLN King and VLN Menthol King are the only FDA-authorized, reduced nicotine cigarettes in the U.S. tobacco products market, estimated at approximately $80 billion in size.