No one was particularly impressed with the FDA’s announcement back in April when it decided to regulate electronic cigarettes for the first time. Many public health advocates and analysts admit that the proposed rules will do very little in the effort to constrain the billion-dollar market for these products, which allows users to inhale nicotine in vapor form.
With the lack of solid scientific evidence and long-term studies, the health risks of e-cigarettes are not well understood, and many people still believe these devices act as a gateway to more traditional tobacco smoking, particularly among youths. The scheduled ecig rules would ban sales of e-cigarettes to minors and require manufacturers to provide a list of ingredients to the agency. It has taken the FDA more than four years to come up with these regulations, which are 241 pages long and they are open to public debate for 75 days, until implementing the final rules.
The Smoke Free Alternatives Trade Association, an electronic cigarette advocacy group, wrote in a statement to the FDA that they ‘welcome a ban on access to anyone under 18,’ but they said they disagree with any restrictions regarding flavor, stating aromas are ‘important to the consumer experience.’
‘I don’t know what took the FDA so long to come up with this,’ declared Neil Schluger, the leading doctor of pulmonary, allergy and critical care medicine at Columbia University Medical Center. ‘One can sort of imagine the battle going on here. On the one hand there are public health groups representing the interests of millions of people, versus tobacco groups with billions of dollars.’
On the other hand, the expected regulations are ‘what we want as an industry,’ said Ray Story, the CEO and founder of the Tobacco Vapor Electronic Cigarette Association (TVECA), an electronic cigarette trade group that represents distributors. ‘We applaud the FDA for finally coming out with these proposed rules.’
Of course, other trade groups had some problems with the proposal, like the Smoke Free Alternatives Trade Association who stated they do not believe that e-cig should be ruled under the same category as other traditional tobacco products. Still, in 2009, the U.S. Congress extended the FDA’s jurisdiction to manage ecigs as part of a tobacco control law that included other products like nicotine gels or water pipes.
The regulation could help concentrate the industry into the hands of major players (like Lorillard, Phillip Morris and Reynolds American who all have a big presence in the e-cigarette landscape) by raising the barrier to entry for the market, according to Bonnie Herzog, the managing director of beverage, tobacco and convenience store research at Wells Fargo. Following with regulations would make the manufacturing electronic cigarettes more expensive, creating difficulties for less-established players to get into the business.