Agency says e-cigs need FDA approval as drug delivery devices
Electronic cigarettes, or e-cigs, have been called the future of smoking. The Food and Drug Administration wants to show a group of electronic cigarette companies what that entails. The FDA has issued a warning to five electronic cigarette companies for making unproven claims that e-cigs will help people quit smoking. Some of the e-cigarette companies were singled out for unsafe manufacturing processes and adulterated products. One electronic cigarette manufacturer was called out for products containing drugs for erectile dysfunction and weight loss. According to the agency, these electronic cigarette companies are violating federal law until their products undergo clinical trials for FDA approval as drug delivery devices.
FDA says e-cigs don’t help smokers quit
Five electronic cigarette companies found nasty letters from the FDA in their mailboxes Thursday. WebMD reports that the letters warned the e-cig firms that their products violate drug safety laws. The FDA has given them 15 working days to revise “practices which violate various provisions of the Federal Food, Drug and Cosmetic Act.” The FDA said all five companies falsely claim their e-cigs help people quit smoking. In a separate letter to the Electronic Cigarette Association, the FDA said e-cigs are legally defined as drug delivery devices and need agency approval to be sold. WebMD said that to get FDA approval, e-cig firms need to conduct lengthy and expensive clinical trials to collect data proving the products are safe. The companies that received FDA warning letters are:
- Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
- E-Cigarette Direct LLC, Parker, Colo.
- Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
- Johnson Creek Enterprises LLC, Johnson Creek, Wis.
- Ruyan America Inc., Minneapolis, Minn.
Inhaling antifreeze from e-cigs
The FDA has done testing of its own on electronic cigarettes. Med Page Today reports that in June the agency published results of lab tests showing e-cigarettes contain carcinogens including nitrosamines and diethylene glycol, a poisonous ingredient in antifreeze. Unlike tobacco cigarettes and FDA-approved nicotine patches and gum, e-cigs have no health warnings on the packaging. The FDA said no e-cigarette company has yet submitted an application to the agency for evaluation or approval.
E-cigs hook a huge following
Electronic cigarettes emerged globally in 2002 and were touted as a safe alternative to tobacco cigarettes. USA Today reports that e-cigs made their first splash in the U.S. in late 2006. Last year the FDA directed customs officials to block entry of imported e-cigs into the country. A federal judge ruled that the FDA overreached by stopping the shipments. The FDA appealed and won a stay of that ruling, pending litigation scheduled for later this month. Meanwhile, the e-cig industry has grown to millions of users worldwide. The industry estimates that another 20,000 to 30,000 people start inhaling their vapors every week.