E-cigarettes, or e-cigs, have been known as the future of smoking. The wants to be part of the action. It hopes to tell e-cigarette businesses what it entails. The FDA has issued a warning to five electronic cigarette corporations for making unproven claims that electronic cigarettes will help people quit smoking. Unsafe manufacturing processes and adulterated products was what some of the e-cigarette businesses were said to have been doing. Interesting drug was found within the product at one of the electronic cigarette corporations. There were drugs for weight loss and erectile dysfunction. According to the agency, these electronic cigarette companies are violating federal law until their products undergo clinical trials for Food and Drug Administration authorization as substance distribution devices.
FDA says e-cigs don’t help smokers quit
Thursday there were probably five angry e-cigarette corporations that found letters within the mailbox from the Food and Drug Administration. WebMD reports the letters warned the e-cig firms that their products violate substance safety laws. They have 15 working days to change things. The FDA said they have to revise “practices which violate various provisions of the Federal Food, Drug and Cosmetic Act.” False claims of helping people quit smoking were made by all five businesses, states the FDA. 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. E-cig firms have to do clinical trials while collecting data showing the e-cigs are safe in order to get FDA approval, says WebMD. The corporations that received FDA warning letters are:
- First is Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
- A next is E-Cigarette Direct LLC, Parker, Colo.
- There’s also Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
- Fourth is Johnson Creek Enterprises LLC, Johnson Creek, Wis.
- Ruyan America Inc., Minneapolis, Minn.
Antifreeze in e-cigs
The FDA conducted electronic cigarette tests. As outlined by Med Page Today, lab test results were posted in June showing that the poisonous ingredient in antifreeze, diethylene glycol, and nitrosamines were both carcinogens in e-cigarettes. You will find warnings about health on all tobacco cigarettes and FDA-approved nicotine patches and gum. E-cigs do not have any health warnings on the label at all. The FDA said no e-cigarette company has yet submitted an application to the firm for evaluation or authorization.
Numerous use e-cigs
The “safe” option to tobacco cigarettes, e-cigs, came out at first in 2002. USA Today reports that e-cigs made their first splash in the U.S. in late 2006. The FDA told customs officials that electronic cigarettes weren’t to be imported into the country anymore. A federal judge said the FDA went too far in stopping shipments. There was then an appeal made by the FDA where they won a stay of ruling. Litigation will happen later this month as scheduled. Meanwhile, the e-cig industry has grown to millions of users worldwide. Each and every week the industry expects 20,000 to 30,000 new customers.
Additional reading
Web MD
webmd.com/smoking-cessation/news/20100909/e-cigarette-firms-get-fda-warning
Med Page Today
medpagetoday.com/PublicHealthPolicy/FDAGeneral/22103
USA Today
usatoday.com/money/industries/food/2010-09-09-fda-electronic-cigarettes_N.htm
