Some physicians agree. “There's no question in my mind that these products are safer than cigarettes,” said Dr. Michael Siegel, a physician and professor of community health sciences at Boston University. “To not allow these companies to tell the truth doesn't make any sense to me.”
Still, many health experts and advocates argue that too little is known about the ingredients used in e-cigarettes to judge their safety or effectiveness as a tobacco cessation aid, and they feel the draft regulations do not go far enough toward establishing further safeguards to help reduce the use of e-cigs among young people.
The proposal would not prohibit online sales of e-cigarettes, television advertising or the production of flavored-nicotine solutions, which critics say target young users.
“If this was really a product designed to replace the cigarette and designed to allow the smoker to get the nicotine they require without having actually smoked, then this thing would have been totally geared only for adults,” said Dr. D. Kyle Hogarth, medical director for the University of Chicago Medical Center's Pulmonary Rehabilitation Program. “When you see their commercials it's always hip and young and they have flavored ones [e-cig solutions], which are always geared towards kids.”
The number of middle-school and high-school students who reported using an e-cigarette doubled from 3.3% in 2011 to 6.8% in 2012, according to a report released last year by the Centers for Disease Control and Prevention.
In 2009 the FDA attempted to regulate e-cigs as a drug-delivery device under the Food, Drug, and Cosmetic Act, which would have required makers to subject their products to lengthy clinical trials to determine their safety and effectiveness.
E-cigarette manufacturers filed a lawsuit challenging the designation, and in 2010 a federal appeals court ruled in favor of the manufacturers, who argued that e-cigs were not medical devices and should be considered tobacco products. Since that time, the industry has exploded in the absence of federal oversight, with as many as 200 brands now sold.
The FDA will accept public comment on the proposal for 75 days beginning Friday.
Follow Steven Ross Johnson on Twitter: @MHsjohnson