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CLARENCE, N.Y. — 22nd Century Group Inc. is growing its executive team to help navigate the company's path through the Food and Drug Administration (FDA) modified-risk process.
Gregg M. Gellman joined the company as director of business development and regulatory affairs. He was hired for his experience in achieving FDA compliance approval for various types of products, according to the company.
Gellman will be 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.
"Hiring Gregg Gellman represents another important step in 22nd Century's mission to bring reduced-exposure cigarettes to American smokers," said Henry Sicignano III, the company's president and CEO. "Unlike some of our larger competitors, who market their products with implied health claims, 22nd Century is committed to working collaboratively with the FDA to demonstrate that our very low nicotine cigarettes and our low tar-to-nicotine ratio cigarettes are legitimate — and enormously important — modified-risk tobacco products."
22nd Century hopes to become the first company authorized by the FDA to market reduced-exposure combustible cigarettes. It intends to submit its application for "BRAND A" to the agency this fall.
At the same time, because regulatory pre-approval is not required to label very low nicotine cigarettes outside of the United States, the company will expand distribution of its MAGIC 0 Very Low Nicotine cigarettes in Europe. As sufficient funds are secured for additional exposure studies, the company intends to submit an application to the FDA for "BRAND B" in 2016.