38 TOBACCO BUSINESS | MAY / JUNE | 22 “When problems arise between people or groups, it’s often because of that [communication]. Until someone invents a mind-reading machine, the best remedy is more communication,” says Zercher. “Like many companies, we have daily and/or weekly review meetings to talk about important projects and our progress toward our goals, but oftentimes fostering collaboration is simply a matter of reminding people to pick up the phone or shoot someone a message to lay out an issue and ask for help. Two people with good intentions can solve any problem big or small if they will just talk it through.” It was through much collaboration and communication that 22nd Century Group was not only able to develop VLN, a cigarette product with very low levels of nicotine, but also get it through the FDA’s rigorous MRTP authorization process. Zercher confesses that the process was not easy and required 22nd Century Group to build a team that understood not just smokers and tobacco products but also how these products are regulated by the FDA. What 22nd Century Group has come to realize is that tobacco products are regulated by the FDA much like the way pharmaceutical drugs are regulated. Regulated products are unique in how they’re developed and ultimately are brought to market. This concept and realization was new to Zercher, who had worked primarily with tobacco products for much of his career. “I was a little surprised to find that there are lawyers and scientists who spend their entire careers dealing with a single class of products, like pharmaceuticals or medical devices, and how to navigate those products through the FDA and bring them to market,” says Zercher. “This was an entirely new landscape for the tobacco industry in 2009 and for 22nd Century when we began this process many years ago.” Figuring out how to navigate the regulation process for tobacco products and how to work with the system rather than against it has been key to 22nd Century Group’s success in recent years. Zercher gives credit to the team that’s been assembled to help get the company to where it is now. “This is a group of external specialists, including lawyers, toxicologists, researchers and clinicians, who are led by our internal team who themselves spent many years before joining 22nd Century navigating the regulatory realm in tobacco and public health,” he says. “Together, they developed a winning regulatory strategy and set of FDA applications that rested upon a body of clinical science done using our products beginning in Before joining 22nd Century Group, Zercher headed American Spirits’ international business unit. He now has over two decades of experience in the tobacco industry. I was a little surprised to find that there are lawyers and scientists who spend their entire careers dealing with a single class of products, like pharmaceuticals or medical devices, and how to navigate those products through the FDA and bring them to market. —Michael Zercher
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