FDA Seeks to Stub Out E-Cigarette Makers' Overblown Health Claims

(Sept. 9) -- The manufacturers of electronic cigarettes today met with the long arm of the health law, as the Food and Drug Administration issued warnings to five companies and announced new, industrywide regulations.

The products, also known as e-cigarettes, are usually designed to resemble traditional cigarettes. Using battery power, they allow a user to inhale a vapor (typically containing nicotine) without accompanying combustion or smoke.

But the wares, which are often marketed as smoking cessation aids or safer alternatives to cigarettes, need to be approved as drugs, according to the FDA.

The agency today issued warnings to Gamucci America, E-Cig Technology Inc., Ruyan America Inc., Johnson Creek Enterprises LLC and E-CigaretteDirect LLC, alleging that they'd made unsubstantiated claims and operated without adequate manufacturing regulation.

Nicotine levels in the products often didn't match claims on the labels, an FDA review found.

In a separate letter to the Electronic Cigarette Association, the FDA also initiated an industrywide clampdown. To be approved for retail sale, all e-cigarette companies need clinical trials to prove that their products are effective at helping smokers quit -- much like nicotine patches or cessation gum products.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter reads.

And this latest move is only the most recent development in an ongoing war between the FDA and e-cigarette companies. Last year, a group of e-cigarette sellers sued the federal agency over efforts to thwart imports. The group won, only to see the FDA appeal and win a stay on the decision.

At the crux of the entire debate is how e-cigarettes are defined. If they're a drug product, they'd fall under the auspices of the FDA's Food, Drug, and Cosmetic Act, making a ban on imports legitimate pending clinical tests and approval. But if the wares are recreational tobacco products, then the FDA would be overstepping its bounds.

"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," reads a statement from U.S. District Judge Richard Leon, who ruled in favor of e-cigarette companies last year. "The devices should be regulated as tobacco products rather than drug or medical products."

Compared to global reactions to e-cigarettes, however, the FDA's stance remains decidedly lax. The products are banned in Canada, Singapore and Australia and are widely restricted elsewhere.