The FDA is continuing its all-out assault on e-cigarettes companies, warning five of them in a letter that they are violating the law, including making unsubstantiated claims and employing poor manufacturing practices. The FDA also wrote to the Electronic Cigarette Association, saying the agency intends to regulate electronic cigarettes.
Electronic cigarettes are nicotine-delivery devices that include a heating element that vaporizes chemicals in replaceable plastic cartridges. A recent FDA analysis found that the device contains toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
The FDA believes they are drug-delivery devices and should have to go through clinical trials. E-cigarette advocates say it's simply a recreational alternative to cigarettes and no FDA regulation is necessary. If they contain carcinogens, advocates say, it's not a significantly relevant amount and they're still better than regular cigarettes.
“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the letter to the association reads.
The FDA is particularly upset that the five companies it cited are claiming, without agency review, that the products help users quit smoking cigarettes. The companies receiving warning letters were: E-CigaretteDirect, Ruyan America, Gamucci America (Smokey Bayou), E-Cig Technology and Johnson’s Creek Enterprises.
- read the FDA release
- here's the response from an e-cig expert