Previous success with attaining FDA approval makes Gellman an obvious choice for his new position.
Gregg Gellman has been appointed the new director of business development and regulatory affairs of 22nd Century Group Inc.
This new position will require Gellman to drive regulatory affairs strategies for the company’s two modified risk cigarettes in development. These new cigarettes include “BRAND A,” the world’s lowest nicotine tobacco cigarette, and “BRAND B,” the world’s lowest tar-to-nicotine ratio cigarette. Gellman is expected to have great success, due to his history with achieving FDA compliance approval for various types of products.
Throughout his career, Gellman has worked intimately with the FDA to ensure products in his charge are designed and tested to be compliant with all FDA regulations. As a development and medical device manager at Greatbatch Inc., Gellman managed the design process and commercialization of multiple FDA-regulated products. Gellman has also proven himself an innovator in the development of new products and has amassed extensive experience in technical and clinical sales training for products ultimately approved by the FDA. Gellman is a graduate of the State University of New York at Buffalo and is certified in Quality Systems for Medical Devices and in Global Product Submissions Directive Requirements.
“Hiring Gregg Gellman represents another important step in 22nd Century’s mission to bring reduced exposure cigarettes to American smokers,” explained Henry Sicignano, III, CEO and president. “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.”
Aiming to become the first company in the world authorized by the FDA to market reduced exposure combustible cigarettes, 22nd Century intends to submit its application for “BRAND A” to the FDA 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 in 2016 an application to the FDA for “BRAND B.”
22nd Century’s 185 issued patents make possible the Company’s two modified risk cigarettes in development. Without a license from 22nd Century, no other company can grow, make, or buy 22nd Century’s proprietary Very Low Nicotine tobacco (95% less nicotine content than conventional tobacco), or 22nd Century’s proprietary Very High Nicotine tobacco leaf that will make possible “BRAND B,” the world’s lowest tar-to-nicotine ratio cigarette.
