The Food and Drug Administration for months has vowed to crack down on the sales and marketing practices of e-cigarette companies. Now the regulatory agency says it plans to propose rules for makers of the products as early as this month.
The policies will have big implications for a fast-growing, largely unregulated industry and its legions of customers.
If the regulations are too strict, they could kill an industry that offers the hope a safer alternative to cigarettes that could potentially help smokers quit. But the agency also has to be sure e-cigarettes really are safer and aren't hooking children on an addictive drug.
"This is a very complicated issue and we must be quite careful how we proceed," said David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the American Legacy Foundation, in a recent panel discussion. "I call this sort of the Goldilocks approach. The regulation must be just right. The porridge can't be too hot, and it can't be too cold."
The regulations will be a step in a long process that many believe will ultimately end up being challenged in court.
Recently, members of Congress and several public health groups have raised safety concerns over e-cigarettes, questioned their marketing tactics and called on regulators to address those worries quickly. Research conducted so far on e-cigarettes -- even by the FDA -- indicates they might not be completely safe, and suggests the devices don't help smokers quit.
The FDA is likely to propose restrictions that mirror those on regular cigarettes, which includes banning sales to minors. Federal regulators also are expected to set product standards and require companies to disclose their ingredients and place health warning labels on packages and other advertising.
Where the real questions remain is how the agency will treat the thousands of flavors available for e-cigarettes. While some companies are limiting offerings to tobacco and menthol flavors, others are selling candy-like flavors such as cherry and strawberry which may appeal to children.
Regulators also must determine if they'll treat various designs for electronic cigarettes differently, some of which have been linked to nicotine poisoning. To prevent that, the FDA could mandate child-resistant packaging.
The FDA also will decide the grandfather date that would allow electronic cigarette products to remain on the market without getting prior approval from regulators -- a ruling that could force some, if not all, e-cigarettes to be pulled from store shelves while they are evaluated by the agency.
Many also anticipate the agency will address issues surrounding the marketing of such products. Companies won't be able to tout e-cigarettes as stop-smoking aids, unless they want to be regulated by the FDA under stricter rules for drug-delivery devices.
The FDA's proposals could curb advertising on TV, radio and billboards, ban sponsorship of concerts and sporting events, and prohibit branded items such as shirts and hats. The agency also could limit sales over the Internet and require retailers to move e-cigarettes behind the counter.