22nd Century Group Makes Progress on Modified Risk

CLARENCE, N.Y. — 22nd Century Group Inc. is seeing some forward progress on its modified risk tobacco product applications (MRTPAs) currently under review by the Food and Drug Administration (FDA).

Last week, the company reported that it has received "helpful and positive feedback" on its combined MRTPAs and premarket tobacco product applications (PMTAs) for its "Brand A" Very Low Nicotine tobacco cigarettes.

The feedback comes roughly a year after the company's wholly owned subsidiary, Goodrich Tobacco Co., submitted MRTPAs and PMTAs to the FDA seeking a reduced exposure order for the BRAND A cigarettes.

More specifically, on Dec. 31, 2015, the company requested in its MRTPAs permission from the FDA to be able to state, as truthful and accurate in BRAND A packaging and marketing, that the company's proprietary Very Low Nicotine cigarettes reduce smokers' exposure to nicotine, the company said.

According to 22nd Century, Brand A has less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette.

Though the company is only requesting an MRTPA marketing order that will allow 22nd Century to disclose that BRAND A reduces smokers' exposure to nicotine, the FDA has requested more information related to the independent clinical studies on the company's Very Low Nicotine tobacco that focused on smoking cessation and harm reduction objectives.

In addition, the agency expressed interest in receiving additional documents pertaining to research findings and statistical analyses related to the focus group studies that were conducted in support of the company's BRAND A applications, according to 22nd Century.

In response to the FDA's requests — and in conjunction with additional clarifying guidance — the company has withdrawn its existing filings in order to file more expansive MRTPAs and PMTAs for BRAND A that will include additional scientific data and information from already completed clinical studies on the company's Very Low Nicotine tobacco cigarettes, in addition to smoking cessation research.

22nd Century also said the company will split its combined application into separate PMTAs and MRTPAs to benefit from the FDA's shorter review timing for PMTAs as compared to MRTPAs.

In September 2015, Gregg M. Gellman joined the company as director of business development and regulatory affairs to help 22nd Century navigate the FDA review process.

He was tasked with driving 22nd Century's regulatory affairs strategies for the company's two modified-risk cigarettes in development: BRAND A, the world's lowest nicotine tobacco cigarette, and BRAND B, the world's lowest tar-to-nicotine ratio cigarette, as CSNews Online previously reported.

Clarence-based 22nd Century is a plant biotechnology company focused on technology that allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding.