FDA Loses Appeal On E-Cigarettes

The U.S. Food and Drug Administration (FDA) does not hold the authority to regulate electronic cigarettes under the drug/device provisions of the Food, Drug and Cosmetic Act, according to a ruling by an appeals court, which upholds a decision by a lower-court, BusinessWeek reported.

The U.S. Court of Appeals in Washington said today the FDA has the authority only to regulate e-cigarettes as a tobacco product.

E-cigarette companies, including Sottera Inc. which does business as NJoy, brought the case to court, arguing their products-battery-powered devices that produce a nicotine vapor instead of tobacco smoke-are tobacco products and not drugs. E-cigarette manufacturers market their products as alternatives to tobacco products for smokers. Sottera noted the products aren’t marketed for therapeutic use but for “smoking pleasure.”

“We’re thrilled,” Craig Weiss, the president of Scottsdale, Arizona-based NJoy, told BusinessWeek. “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.”

“We are studying the opinion and considering next steps,” Jeffrey Ventura, a spokesman for the FDA, said in a statement.




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