It’s been a busy week of letter-writing for the FDA. First, they sent out miffed missives to Canada Dry and Lipton over their questionable claims about their green tea drinks. Now the regulators are going after five manufacturers of electronic cigarettes for what the FDA alleges are illegal marketing tactics.
For those not aware of e-cigarettes, they are little battery-powered sticks that look like cigarettes but provide the user with vaporized nicotine instead of tobacco smoke.
What has the FDA riled up are claims made by ads for e-cigarettes that say e-cigarettes can curb or cure nicotine addiction. And according to the Federal Food, Drug and Cosmetic Act, any product that claims it can be used to treat a disease — in this case nicotine addiction — is therefore classified as a drug and needs to meet different standards for safety and effectiveness.
“We are interested in finding out whether e-cigarettes can be proven safe and effective. That is why we sent out the letter to the Electronic Cigarette Association,” a rep for the FDA’s Center for Drug Evaluation and Research explained.
The five companies receiving warnings from the FDA are: E-CigaretteDirect LLC; Ruyan America Inc; Gamucci America, also known as Smokey Bayou Inc; E-Cig Technology Inc and Johnson’s Creek Enterprises LLC.
Also peeving the FDA is the fact that some of these companies don’t limit their e-cigarette use to just nicotine, selling liquid versions of other drugs for purposes of vaporizing.
E-Cig Technology, for example, markets the erectile dysfunction drug tadalafil, sold by Eli Lilly as Cialis, and a liquid version of the weight-loss drug rimonabant or Compal, a Sanofi-Aventis drug that never won U.S. marketing approval and was pulled from the market in Europe because of safety concerns.