Judge Says FDA Has No Authority Over Electronic Cigarettes - WSJ.com
BUSINESS- JANUARY 14, 2010, 2:57 P.M. ET
FDA Has No Authority Over Electronic Cigarettes, Judge Says
By JARED A. FAVOLE
WASHINGTONA U.S. judge said the Food and Drug Administration doesn't have authority to regulate electronic cigarettes, dealing a blow to the agency's efforts to regulate tobacco products as drugs or devices.
In a 32-page opinion, U.S. District Judge Richard J. Leon sided with electronic-cigarette maker Smoking Everywhere Inc. in finding that the FDA has no authority to regulate the products and can't stop them from entering the country.
"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," Judge Leon said in his ruling. He added the FDA's "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 and unacceptable."
Representatives of the FDA and Smoking Everywhere weren't immediately available for comment.
The FDA has seized shipments of electronic cigarettes, which look and taste like cigarettes but don't contain tar, amid concerns the products were being marketed as safer alternatives to traditional tobacco. The FDA asserted its power by saying the electronic cigarettes were essentially drugs or devices that were being imported without FDA approval.
Electronic cigarettes are battery-powered tubes that contain an atomizer, a battery and a cartridge filled with liquid nicotine. Florida-based Smoking Everywhere, one of the largest makers of electronic cigarettes, had challenged the FDA's authority to regulate the products. The company has imported and sold more than 600,000 units of electronic cigarettes, according to the judge's opinion.
Electronic cigarettes are facing challenges from attorneys general in California and New Jersey amid reports from the FDA that the products contain cancer-causing chemicals.
California State Attorney General Jerry Brown filed suit Wednesday in Alameda County Superior Court against Smoking Everywhere. Mr. Brown said the company has no evidence to back up claims their product is safe.
Judge Leon's opinion comes a week after a district-court judge in Kentucky largely ruled in favor of the FDA by saying the agency can restrict tobacco advertising. In that case, tobacco giants such as Reynolds American Inc. and Lorillard Inc. said the FDA restrictions on tobacco ads infringes on their First Amendment rights.
Write to Jared Favole at jared.favole@dowjones.com
BUSINESS- JANUARY 14, 2010, 2:57 P.M. ET
FDA Has No Authority Over Electronic Cigarettes, Judge Says
By JARED A. FAVOLE
WASHINGTONA U.S. judge said the Food and Drug Administration doesn't have authority to regulate electronic cigarettes, dealing a blow to the agency's efforts to regulate tobacco products as drugs or devices.
In a 32-page opinion, U.S. District Judge Richard J. Leon sided with electronic-cigarette maker Smoking Everywhere Inc. in finding that the FDA has no authority to regulate the products and can't stop them from entering the country.
"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," Judge Leon said in his ruling. He added the FDA's "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 and unacceptable."
Representatives of the FDA and Smoking Everywhere weren't immediately available for comment.
The FDA has seized shipments of electronic cigarettes, which look and taste like cigarettes but don't contain tar, amid concerns the products were being marketed as safer alternatives to traditional tobacco. The FDA asserted its power by saying the electronic cigarettes were essentially drugs or devices that were being imported without FDA approval.
Electronic cigarettes are battery-powered tubes that contain an atomizer, a battery and a cartridge filled with liquid nicotine. Florida-based Smoking Everywhere, one of the largest makers of electronic cigarettes, had challenged the FDA's authority to regulate the products. The company has imported and sold more than 600,000 units of electronic cigarettes, according to the judge's opinion.
Electronic cigarettes are facing challenges from attorneys general in California and New Jersey amid reports from the FDA that the products contain cancer-causing chemicals.
California State Attorney General Jerry Brown filed suit Wednesday in Alameda County Superior Court against Smoking Everywhere. Mr. Brown said the company has no evidence to back up claims their product is safe.
Judge Leon's opinion comes a week after a district-court judge in Kentucky largely ruled in favor of the FDA by saying the agency can restrict tobacco advertising. In that case, tobacco giants such as Reynolds American Inc. and Lorillard Inc. said the FDA restrictions on tobacco ads infringes on their First Amendment rights.
Write to Jared Favole at jared.favole@dowjones.com
