But both of those things are true, and you only have to be around the infectious enthusiasm of the company's new CEO Matt Salmon, a former member [image-nocss] of the U.S. congress, for a few minutes to start believing.
Salmon also was formerly president of the Electronic Cigarette Association, and has been at the helm of Sottera for the past few months. All of this as a nonsmoker, who does not like the smell of cigarette smoke. "But I still believe that smokers aren't third-class citizens, and they deserve to have some rights too. And I think that this [e-cigarettes] is a great middle ground," he told CSP Daily News.
He took the position at Sottera in October 2010, just before a verdict was handed down in the company's case against the FDA. "I agreed before the decision was made, which was kind of scary and a leap of faith. But now that the decision has been made, I think I made a really good decision."
In December of last year, three judges of the U.S. Court of Appeals for the D.C. Circuit ruled that the FDA can only regulate electronic cigarettes as tobacco products and not as drugs--and therefore cannot block their import. Salmon estimates that his company spent about $2.5 million and a year and a half to get to that point--not to mention the "tens of millions of dollars" lost in FDA-confiscated product.
"They were ambiguous about what their policies were and so it kind of was the worst of every world. Nobody knew where they stood, so people just took their chances. You'd ship, and some would get seized and some wouldn't," he said.
The FDA later appealed that decision, also in December. A court document provided to CSP Daily News by the FDA states: "This case is an appeal from a preliminary injunction that exempts plaintiff's 'electronic cigarettes' from regulation under the drug and device provisions of the Federal Food, Drug & Cosmetic Act unless they are intended for therapeutic use."
The "fundamental error," outlined in the document, is that the ruling was based on treating the products as part of "the tobacco problem," rather than "part of the solution to the tobacco problem."
Jeff Ventura, spokesperson for the FDA, added, "The FDA continues to evaluate recent court decisions and is evaluating next steps."
Salmon remains unfazed, however. "Nobody's really holding their breath, and expecting that they're going to get it. It's business as usual, and it's expanding quite rapidly."
Some of that expansion has included hiring a company to oversee quality control and production standards in China--where the e-cigarettes are manufactured. "What we're wanting to do is bring everything in line with FDA standards and move as quickly as we possibly can to ensure that our research and development and our product development is second to none--and we're moving as quickly as we can."
Salmon said that he also expects growth thanks to an unlikely source: Hollywood. In The Tourist, Johnny Depp even waxes on about e-cigarette technology. "I imagine after a guy as cool as Johnny Depp in that movie gives a whole education on electronic cigarettes, it will really go through the roof. I know there are several actors that use them leisurely, too."
He added, "It's all coming to a crescendo at the same time, and in two years NJOY will be a household term."
Meanwhile, Salmon expressed a lack of hard feelings toward the FDA. "We're excited to work with the FDA to craft some meaningful regulatory policy that conforms to what the courts have set down."
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.