E-cigarettes are about to become a regulated product. The Food and Drug Administration is set to propose a regulatory plan Thursday that will also put some restrictions on the sale and marketing of e-cigarettes to minors.
Though the FDA stopped short of banning advertising, it does propose to prohibit sales to minors, halt the distribution of free samples and require health warnings and ingredients labels.
Following a 75-day comment period, the FDA will finalize the rules. The e-cigarette companies would have to comply with the marketing and sales restrictions almost immediately, but would have two years to submit their products for the FDA’s review and approval.
"This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products," said FDA commissioner Margaret Hamburg, M.D.
The fast-growing e-cigarette business has mushroomed into a $2 billion industry, generating plenty of controversy and calls from lawmakers that the industry's marketing tactics should be regulated.
"It's like the wild, wild west," Hamburg said in an interview with Bloomberg TV. "The products are evolving with no regulatory oversight and are being marketed in ways that are very worrisome," she said.
Depending on your point of view, e-cigarettes are either a panacea for smokers or a gateway drug. The Centers for Disease Control put out a study last year that e-cigarette use among teens has surged; more recently the agency released data showing an increase in reported poison incidents among children under 6.
Reactions from the e-cigarette industry to the FDA's 241 pages of proposed regulations were mixed, but generally, the industry had no quibble with the age restrictions or even the marketing restrictions.
There was some concern that the proposal would regulate e-cigarette marketplace the same way the FDA currently handles tobacco by imposing a costly and time-consuming application and review process that some estimate can take 5,000 hours just to file.
"As a new category of technology product, vaporizing deserve a new and distinct set of regulations," said the Smoke Free Alternatives Trade Association.
"It's a burden that can only be borne by large tobacco companies," said Gregory Conley, president of the American Vaping Association. "The GAO [Government Accountability Office] has already reported that the FDA has thousands of tobacco applications backlogged," he added.
But Jason Healy, founder of blu ecigs, counters that regulation of the nascent business was inevitable. "Did you think this was going to be easy? We're in the tobacco space, and we have a responsibility. There has to be some governance and some pain. It'll be painful and sticky."