There s plenty of bad news as well in the FDA s just-released proposed e-cig regulations. But for me and for the 44 million smokers in America, a sigh of relief was audible. We had been concerned, mainly, that the hyper-regulatory atmosphere at the FDA and other federal agencies might actually lead to a ban of these products, either overtly or via a stringent, pharmaceutical-type approval process. That thankfully did not come to pass.
Most smokers want to quit yet cannot with the currently available FDA-approved products: the continued availability of electronic cigarettes (including vapor products and cigalikes) is reassuring, as this method provides addicted smokers with their best chance of quitting. While the agency didn t ban any, they do require any new products (meaning since 2007, meaning 99 percent of the current market) to apply for approval and submit evidence to support that request. On the one hand, the products will be allowed to remain on the market during this long process; on the other, the financial and intellectual toll will force many of the smaller companies into bankruptcy or buyout/takeover by the majors.
Moreover, for even those e-cig/vapor companies who manage to survive, the rules will stifle innovation. They are unduly onerous and are not based on sound science, requiring 99% of the current products to apply for FDA approval (any product on the market before 2/15/07 is automatically OK, but that s a minuscule sliver of the current market). Many smaller e-cig companies will either go under or seek protection from Big Tobacco via buyout/takeover.
While these proposed regs. will in the best of circumstances take 3-4 years to become fully implemented, the likelihood of litigation will prolong even that interval. During this period and at its end, Big Tobacco will come out the winner, by either or both of these paths: absorbing small companies unable to bear the FDA approval expense, or just by waiting it out their financial and marketing/lobbying expertise will enable them to be-- if not the only ones left standing among the only ones left standing.
Sadly, the onerous aspects of these regulations were not based on sound science. It is obvious that e-cigs are much less harmful than the toxic slew of chemicals in tobacco smoke, yet the agency did not relax the law that prevents companies from truthfully telling that to smokers. Also, the FDA actually has no authority, never did, to ban internet sales or advertising in general; so that triumph is hollow. They could have restricted flavorings, as the FSPTCA did for cigarettes but they didn t, so that s good adults prefer flavors.
Another silver lining is the fact that, since at last, the FDA has spoken, it will make it that much harder for pompous, hypocritical politicians in cities and states to render their inane bans and restrictions, using the theme that since the FDA hasn t provided us any guidance, someone s gotta do it." The perverse campaign that has spread nationwide from NYC to restrict these beneficial products may now, at last, come to a halt, albeit too late for New York vapers and others.
