FDA electronic cigarette regulations looming
Long-awaited rules regulating the production and marketing of electronic cigarettes could be a breath away, Food and Drug Administration Commissioner Dr. Margaret Hamburg told a Senate subcommittee last week.
A proposed rule is currently being analyzed by the White House Office of Management and Budget, she said. She predicted the rule will be issued “very soon.”
Proponents and critics of e-ciga- rettes have been waiting for years for the FDA to deliver rules for the devices. Supporters say e-cigs could help millions of Americans quit smoking regular cigarettes. But anti-smoking groups argue that not enough is known about the ingredients and health effects of ecigs, which use a battery to heat a liquid nicotine solution that is inhaled.
The agency attempted to ban e-cigs in 2009 on the grounds the products were “an unapproved drug-device combination” under the Food, Drug, and Cosmetics Act. But a federal appeals court in 2010 ruled in favor of manufacturers who said they were not medical devices, and should be regulated as tobacco products, allowing wide-open marketing and sales. Since then, the FDA, which began overseeing tobacco products in 2009, has worked on rules that some predict will impose restrictions on marketing and sales of e-cigs to minors.
At the hearing, Sen. Jeff Merkley (DOre.) criticized Hamburg and the FDA for delays in issuing a proposed rule, saying the marketing of e-cigs is a major public health hazard. “Let’s not let another month pass with this thing gathering dust in some bureaucrat’s closet,” he