The move is aimed at extending government oversight to the new and mostly unregulated industry. E-cigarettes makers say the devices are safer than traditional cigarettes, but critics say more studies are needed to determine the products' potential health risks.
Under the proposed rule, the FDA's authority would be extended to products the agency deems meet the statutory definition of a tobacco product, include e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipes -- or hookahs -- and tobacco "dissolvables" not already under the FDA's authority.
Federal law prohibits the sale of tobacco cigarettes to anyone under 18, but there is no such restriction for e-cigarettes. The limited federal oversight has led to a boom in the e-cigarette industry, with sales doubling annually since 2008. Revenue last year was expected to reach at least $1.5 billion.
E-cigarettes don't burn tobacco. Instead, the battery-powered inhalers vaporize a mixture typically composed of liquid nicotine, propylene glycol and other chemicals.
Most researchers say e-cigarettes are safer than traditional cigarettes because tobacco isn't ingested into the lungs and they don't produce second-hand smoke, although few studies have been conducted on their long-term health risks.
The FDA will collect public comments on the proposed rule for 75 days. Officials announced no timetable for the new rule.
Consistent with currently regulated tobacco products, the proposed rule calls for e-cigarette makers to register with the FDA and report product and ingredient listings, and would be allowed to sell new products only after FDA review.
The proposal also would bar e-cigarette companies from marketing their products as a healthier alternative to traditional cigarettes unless the FDA confirms confirms that scientific evidence supports the claim. Distribution of free samples also would be banned.
Sales of the products to minors, public health warnings and restrictions on vending machine sales also are included in the proposal.
"Tobacco-related disease and death is one of the most critical public health challenges before the FDA," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims."
A report released last week by 11 Democratic lawmakers accused e-cigarette makers of targeting minors through social media, radio and televisions advertisements, sponsoring events with young audiences, and selling fruit and candy-flavored products.
Senate Majority Whip Dick Durbin of Illinois, who helped spearhead the report, said Thursday that while the FDA proposal to ban e-cigarette sales to minors was a "positive step," the agency's proposal didn't go far enough to keep the product out of the hands of children.
"Today, after years of waiting for the FDA to act, we are extremely disappointed by its failure to take comprehensive action to prevent e-cigarette companies from continuing to deploy marketing tactics aimed at luring children and teenagers into a candy-flavored nicotine addiction," he said.
"As long as e-cigarette companies continue to take pages from Big Tobacco’s old and cynical marketing playbook, our children will remain vulnerable to the grave dangers of nicotine addiction."
The National Center for Public Policy Research, a conservative think tank, said it has concerns about how the FDA would regulate the industry.
"The devil will be in the details," said Jeff Stier, the group's risk analysis director. "If the regulations are too heavy-handed, they'll have the deadly effect of preventing smokers from quitting by switching to these dramatically less harmful alternatives."
He added the proposed regulatory scheme could be expensive and burdensome for smaller e-cigarette companies, "thus slowing product improvements that would make e-cigarettes a more appealing alternative to even the most addicted smokers."