PMTA for low-nicotine cigarettes

| December 5, 2018

22nd Century Group has submitted a Premarket Tobacco Application (PMTA) with the U.S. Food and Drug Administration (FDA) seeking authorization to commercialize the company’s Brand A cigarette products under the proposed brand name VLNTM (the product name is subject to FDA approval). 22nd Century’s proposed VLNTM cigarettes are made with the company’s proprietary VLNTM tobacco and, as a result, contain very low levels of nicotine.

A PMTA marketing order is a prerequisite to commercializing any new tobacco product in the United States. The company’s PMTA submission precedes the forthcoming filing of the separate, more comprehensive Modified Risk Tobacco Product (MRTP) application for 22nd Century’s proposed VLNTM premium cigarettes.

22nd Century’s MRTP application will request FDA authorization for the company to state on packaging and advertising that, among other things, the proposed VLNTM cigarettes contain just 0.5 mg nicotine per gram of tobacco.

In contrast, a survey of the top 100 leading cigarette brands in the United States showed that conventional cigarettes currently sold in the United States contain an average of 19.4 mg of nicotine per gram of tobacco (with an actual nicotine range of 14.7 mg to 33.2 mg per gram of tobacco), according to 22nd Century.

22nd Century’s proposed VLNTM cigarettes are modeled after the company’s Very Low Nicotine Content (VLNC) Spectrum research cigarettes. 22nd Century’s PMTA for the proposed VLNTM brand cigarettes references more than 50 independent studies conducted using the company’s proprietary Spectrum research cigarettes.

In March 2018, the FDA announced its plan to issue a proposed rule that, when finalized and effective, would limit the amount of nicotine in all cigarettes sold in the United States to minimally or non-addictive levels.

In October 2018, Lynn Hull, lead pharmacologist at the Division of Individual Health Science within the FDA’s Center for Tobacco Products, held a webcast highlighting and summarizing the published science surrounding VLNC cigarettes. During the webcast, Hull indicated a minimally non-addictive level of nicotine in cigarettes could be approximately between 0.2 mg to 0.7 mg nicotine per cigarette.

“Later this month, 22nd Century will submit to the FDA the company’s highly-anticipated MRTP application,” explained Henry Sicignano, chief executive officer and president at 22nd Century Group.”

“Containing only a tiny fraction of the nicotine found in the 100 leading U.S. cigarette brands, 22nd Century’s proposed VLNTM cigarettes will demonstrate conclusively that the FDA’s plan to dramatically reduce nicotine in all U.S. cigarettes is immediately feasible,” he said.

“As potentially the first—and only—combustible cigarettes to achieve a marketing order from the FDA under the MRTP program, 22nd Century’s proposed VLNTM cigarettes will provide smokers with a nearly nicotine-free choice… and will change the tobacco industry forever,” said Sicignano.

Category: Breaking News

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