Low Nicotine Cigarettes Application Presented to FDA Advisory Committee

Stakeholders for a pair of low nicotine products presented new data in front of the US Food and Drug Administration’s (FDA) Tobacco Product Scientific Advisory Committee (TPSAC) showing the low nicotine cigarettes were safer than conventional cigarettes.

22^nd Century Group is currently seeking a Modified Risk Tobacco Product (MRTP) designation for the VLN King Box and VLN Menthol King Box after claiming the products contain 95% less nicotine than the top 100 cigarette brands in the US and reduce overall nicotine consumption.

While data and testimony was heard, the TPSAC did not vote on recommendations for the VLN products following the Feb. 14 hearing.

In order for 22^nd Century Group to receive a MRTP designation from the FDA, the company must demonstrate a public health benefit if the product is placed in the marketplace.

The FDA previously confirmed the potential public health benefits of reduced consumption of nicotine by several currently approved tobacco products, saying the VLN cigarettes would ultimately lead to 5 million additional adult smokers quitting one-year following implementation.

Both VLN tobacco products met their maximum nicotine specification of 0.7 mg/g on a dry weight basis.

The FDA’s preliminary scientific review found the claim of an approximate 95% reduction in nicotine in the tobacco itself, the smoke it yields, and the nicotine that is absorbed when it is smoked is correct.

There are some concerns from advocacy groups over whether low nicotine cigarettes will result in consumers smoking more cigarettes to reach their desired nicotine levels.

When the VLN cigarettes are used with normal nicotine content cigarettes, nicotine exposure is still significantly reduced.

In clinical studies, investigators found smokers who do not intend to quit still reduced their cigarettes per day by about 30% after 6 weeks and 50% after 20 weeks.

The studies, as well as peer-reviewed literature, show that the abuse liability of the VLN cigarettes is similar to nicotine replacement therapy gum.

Smokers who switched completely to VLN cigarettes reduced their cigarettes per day and nicotine dependence scores, even among smokers who continued to dual use the product with their usual brand cigarettes.

“We believe that all adult smokers have the right to know that our VLN products have 95% less nicotine than conventional cigarettes; an authorization under the MRTP regulatory pathway will enable this,” John Pritchard, Vice President of Regulatory Science for 22nd Century Group, said in a statement.

22^nd Century Group is a plant biotechnology company on technologies enable it to regulate the level of nicotine in tobacco plants and the level of cannabinoids in hemp and cannabis plants through genetic engineering and modern plant breeding.

According to the FDA, chronic and compulsive consumption of tobacco smoke for nicotine leads to the exposure of numerous toxicants and known carcinogens, resulting in nearly 500,000 annual deaths in the US and 7 million deaths globally.