James E. Swauger has joined 22nd Century Group as senior vice president of science and regulatory affairs. Previously, Swauger was the leader of the scientific and regulatory functions at Reynolds American Inc. (RAI).
Swauger was employed at RAI and its predecessor companies from 1993 through 2016 in various positions of significant scientific and regulatory responsibility. While serving as the vice president of regulatory oversight, from 2008 through 2016, Swauger managed the creation, submission and oversight of numerous scientific applications and regulatory filings with the U.S. Food and Drug Administration (FDA) and other federal, state and local regulatory agencies.
Swauger’s primary responsibility at 22nd Century will be to lead and oversee the company’s scientific and regulatory activities. He will spearhead the re-submission to the FDA of the company’s Modified Risk Tobacco Product (MRTP) application for Brand A very low nicotine content cigarettes, and will work in support of the FDA’s plan to mandate the reduction of the nicotine content of cigarettes to minimally or non-addictive levels.
On July 28, the FDA announced its plan to mandate that all cigarettes sold in the United States contain very low nicotine tobacco. 22nd Century has developed tobaccos that contain 95 percent less nicotine than the tobacco used in conventional cigarettes. The company’s proprietary tobacco has been used in more than $100 million in independent clinical studies funded by the FDA and other federal government agencies.
“I am thrilled with the opportunity to join the 22nd Century team and I look forward to working with a company that is dedicated to reducing the harm caused by smoking,” said Swauger. “It is clear that 22nd Century’s proprietary very-low-nicotine technology is a leading driver in the tobacco harm reduction movement. With the potential to prevent millions of premature deaths and to save billions of dollars in healthcare costs, 22nd Century’s technology is a game-changer.”
“Dr. Swauger’s past successes—in both the tobacco and pharmaceutical businesses of a major tobacco company—are very impressive,” explained Henry Sicignano, III, president and CEO of 22nd Century Group. “I am confident that Dr. Swauger’s extensive regulatory and scientific leadership will prove invaluable to 22nd Century as we aggressively push forward our MRTP application for the world’s lowest nicotine tobacco cigarettes.”