Source: www.boston.com
Author: staff

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 yesterday 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 FDA is asking the companies to let the agency know within 15 business days how it plans to correct the violations. The other companies receiving warning letters were E-CigaretteDirect LLC of Colorado, Ruyan America Inc. in Minneapolis, Gamucci America in Florida, and Johnson Creek Enterprises LLC of Wisconsin.

But in a letter to the Electronic Cigarette Association, the FDA said the actions were not meant to be seen as a larger effort to ban e-cigs. It urged 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.

“We are interested in finding out whether e-cigarettes can be proven safe and effective,’’ said Michael Levy, FDA compliance lawyer.