FDA Sends Warning Letters to E-Cigarette Companies

Published September 9, 2010

RICHMOND, Va. (AP) — The Food and Drug Administration is lighting a fire under the electronic cigarette industry to work with the agency to legally market the devices and is cautioning other companies that their sales and manufacturing practices violate federal law.

The FDA said Thursday it sent warning letters to five companies that make e-cigarettes or components for the plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the "smoker" inhales.

In the letters, the FDA said the companies are violating the Federal Food, Drug and Cosmetic Act, including unsubstantiated claims and poor manufacturing practices.

The companies receiving warning letters are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America, E-Cig Technology Inc. and Johnson Creek Enterprises LLC.

But in a letter to the Electronic Cigarette Association, the FDA said the actions against the companies were not meant to be seen as a larger effort to ban e-cigs. The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials.

The battery-powered electronic cigarettes have become the center of a fight over how risky they are compared with traditional smokes, whether they're legal and, if they are, how they should be regulated.

The FDA and public health groups have sounded the alarm, saying they contain dangerous chemicals and are being marketed to children, and the federal agency has halted shipments of e-cigarettes at ports nationwide.

Some sellers of e-cigarettes sued the FDA last year after the agency instructed customs officials to refuse entry of shipments into the U.S. A federal judge ruled that the FDA can't stop those shipments, saying the agency had overstepped its authority. The FDA appealed, and won a stay of that ruling, pending oral arguments that are set to begin later this month.

While the FDA claims it has the authority to regulate e-cigarettes as drug-delivery devices, some sellers contend the products should be regulated as a tobacco product, which would follow the same restrictions as traditional cigarettes and tobacco products.

Written by MICHAEL FELBERBAUM,AP Tobacco Writer

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