Federal says FDA overstepped bounds, sides with electronic cigarette makers

Judge: FDA cannot regulate electronic cigarettes

WASHINGTON — A federal judge says the Food and Drug Administration overstepped its authority in recent efforts to regulate electronic cigarettes.

A ruling by U.S. District Court Judge Richard Leon handed down Thursday sides with two electronic cigarette suppliers, Smoking Everywhere and NJOY, in their lawsuit against the FDA.

The companies sued the government after regulators began halting shipments of electronic cigarettes last year. The FDA said it found cancer-causing ingredients in the products, despite manufacturers’ claims that the products are safer than tobacco cigarettes.

Electronic cigarettes use a battery-operated vaporizer to produce a nicotine mist that simulates inhalable smoke. Manufacturers have touted the products as a healthier alternative to smoking because there is no burning involved.

The FDA argued that electronic cigarettes are in fact a combination drug-device, and therefore subject to stricter safety standards than cigarettes.

But Judge Leon rejected that reasoning, agreeing with manufactures that electronic cigarettes are “the functional equivalent of traditional cigarettes.”

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” states Leon’s ruling. “Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable.”

Leon was appointed to the U.S. District Court by President Bush in 2002.

The FDA recently gained the power to regulate tobacco-based cigarettes, but since electronic cigarettes don’t contain tobacco they don’t fall under that regulation.

The Campaign for Tobacco Free Kids said Leon’s ruling, if upheld, “opens a gaping hole in the protection FDA has provided against the sale and distribution of non-tobacco products.”