While e-cigarette supporters say the Food and Drug Administration's proposed rule to regulate electronic cigarettes will hamper efforts to get smokers to abandon deadly tobacco cigarettes, many public-health advocates fear the new rules don't go far enough to regulate these new products whose health effects are still unknown.
The long-awaited rule, issued last week, would ban the sale of e-cigarettes to anyone under 18, require producers to stop giving free samples, and require warning labels stating that nicotine is addictive. Manufacturers would have to disclose ingredients and could not say their products are safer than tobacco products.
Both e-cigarette supporters and critics agree the proposed rules are merely a first step rather than the government's final word. Some observers say the FDA chose to move cautiously because of legal and political pressures and because of how little is known about the products.
The agency's action has been delayed for years by legal battles that began in 2009 when it first attempted to regulate e-cigs as a drug-delivery device under the Food, Drug, and Cosmetic Act. E-cigarette makers sued to challenge that designation, saying e-cigs should be considered tobacco products, not medical devices. In 2010, a federal appeals court sided with e-cigarette manufacturers.
Since then, e-cig sales have taken off, with no regulatory oversight. As many as 200 brands are now sold. E-cigarette sales reached nearly $2 billion in 2013. Industry analysts predict sales will eclipse the $80 billion-a-year tobacco-cigarette market by 2040.