FDA authorization needed on electronic cigarettes as substance delivery products

E-cigs are the electronic cigarettes that are called the future of smoking. The FDA wants to be part of the action. It hopes to tell e-cigarette businesses what it entails. The Food and Drug Administration is mad that five of the electronic cigarette corporations claimed e-cigs will quit smoking in marketing. Some e-cig businesses had unsafe manufacturing processes and adulterated products. One electronic cigarette manufacturer was called out for products containing drugs for erectile dysfunction and weight loss. Until all products get Food and Drug Administration authorization with clinical trials, the e-cigarette businesses are violating laws, says the organization.

E-cigs don’t help you stop smoking, says FDA

Five electronic cigarette corporations found nasty letters from the FDA in their mailboxes Thursday. The letters explained, according to WebMD, that substance safety laws are being broken with e-cig firms and their product. 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.” The Food and Drug Administration says there were false claims made by the five companies. They claimed to help people quit smoking. The FDA sent another letter to the Electronic Cigarette Association saying that an approval has to be made on drug delivery devices as the e-cig is legally defined. WebMD said that to get FDA approval, e-cig firms have to conduct lengthy and costly clinical trials to collect data proving the products are safe. As follows are the companies with Food and Drug Administration warning letters:

1. First is Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
2. A next is E-Cigarette Direct LLC, Parker, Colo.
3. There’s also Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
4. There’s also Johnson Creek Enterprises LLC, Johnson Creek, Wis.
5. Ruyan America Inc., Minneapolis, Minn.

Antifreeze in e-cigs

The FDA conducted electronic cigarette tests. Med Page Today showed some tests that the Food and Drug Administration published in June on the electronic cigarettes. These tests showed that carcinogens such as nitrosamines and also the poisonous ingredient in antifreeze, diethylene glycol, are both in e-cigarettes. E-cigs do not have any warnings about health on the package like tobacco cigarettes and FDA-approved nicotine patches and gum have. The FDA said no e-cigarette business has yet submitted an application to the firm for evaluation or approval.

E-cigs wanted by many

Electronic cigarettes emerged globally in 2002 and were touted as a safe option to tobacco cigarettes. Electronic cigarettes didn’t really get started until 2006 though, says USA Today. The country was not allowed to accept any more e-cigs which were imported. The FDA made sure customs officials knew. Stopping shipments was too much. A federal judge ruled against the FDA. The FDA appealed and won a stay of that ruling, pending litigation scheduled for later this month. The result will affect millions. Millions use the e-cig. The industry estimates that an additional 20,000 to 30,000 individuals start inhaling their vapors every week.

Find more info on this subject

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