FDA Loses Appeal, Can’t Regulate E-Cigarettes as Drug

(Updates with FDA, company comments starting in fourth paragraph.)

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Dec. 7 (Bloomberg) — The U.S. Food and Drug Administration lacks the authority to regulate electronic cigarettes under the drug/device provisions of the Food, Drug and Cosmetic Act, an appeals court ruled, upholding a lower-court decision.
The U.S. Court of Appeals in Washington said today the FDA has the authority only to regulate e-cigarettes as a tobacco product.

The case was brought by e-cigarette companies including Sottera Inc., which argued that their products, battery-powered devices that produce a nicotine vapor instead of tobacco smoke, are tobacco products and not drugs.
“We are studying the opinion and considering next steps,” Jeffrey Ventura, a spokesman for the FDA, said in an e-mailed statement.
Sottera, which does business as NJoy, and other e-cigarette manufacturers market their products as alternatives to tobacco for smokers. Sottera argued that the products aren’t marketed for therapeutic use but for “smoking pleasure.”
“We’re thrilled,” Craig Weiss, the president of Scottsdale, Arizona-based NJoy, said in a telephone interview. “NJoy has taken many steps to be the industry leader in terms of responsible marketing of electronic cigarettes. Now we can continue to sell e-cigarettes under the regulations of the Tobacco Act.”

The case is Sottera Inc. v. Food & Drug Administration, 10-5032, U.S. Court of Appeals, District of Columbia Circuit (Washington). The lower-court case was Smoking Everywhere Inc. v. U.S. Food and Drug Administration, 1:09-cv-00771, U.S. District Court, District of Columbia (Washington).
To contact the reporter on this story: Don Jeffrey in New York at [email protected]
To contact the editor responsible for this story: David E. Rovella at [email protected]

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