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Firm States E-cigs Need FDA Authorization As Substance Distribution Products
Electronic cigarettes, or e-cigs, are already called the future of smoking. The FDA wants to show a group of e-cigarette companies what that entails. The FDA has issued a warning to five electronic cigarette businesses for making unproven claims that e-cigs will help people quit smoking. Some e-cig businesses had unsafe manufacturing processes and adulterated products. One of the electronic cigarette manufacturers had drugs for impotence problems and weight loss in its product. Until all products get Food and Drug Administration approval with clinical trials, the e-cigarette businesses are violating laws, says the agency.
Food and Drug Administration says e-cigs will not stop you from smoking
The Food and Drug Administration sent nasty letters on Thursday to electronic cigarette businesses. Five were chosen to receive it. WebMD reports that the letters warned the e-cig firms that their products violate drug 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." The FDA said all five businesses falsely claim their electronic cigarettes help individuals quit smoking. The e-cig is legally defined as a drug delivery machine, states the FDA. In a letter to the Electronic cigarette Association, it stated the e-cigs require authorization before being sold. E-cig firms have to do clinical trials while collecting data showing the e-cigs are safe in order to get FDA approval, states WebMD. Companies with FDA warnings are:
- Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
- E-Cigarette Direct LLC, Parker, Colo.
- There's also Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
- There's also Johnson Creek Enterprises LLC, Johnson Creek, Wis.
- And then there's Ruyan America Inc., Minneapolis, Minn.
Inhaling antifreeze from e-cigs
Tests were done by the FDA. These tests were on electronic cigarettes. Med Page Today showed some tests that the FDA published in June on the e-cigs. These tests showed that carcinogens for instance nitrosamines and also the poisonous ingredient in antifreeze, diethylene glycol, are both in e-cigarettes. You will find warnings about health on all tobacco cigarettes and FDA-approved nicotine patches and gum. E-cigs don't have any health warnings on the label at all. The FDA said no e-cigarette business has yet submitted an application to the agency for evaluation or authorization.
E-cigs popular
Electronic cigarettes emerged globally in 2002 and were touted as a safe choice to tobacco cigarettes. Electronic cigarettes didn't really get began until 2006 though, states USA Today. Last year the FDA directed customs officials to block entry of imported e-cigs into the country. A federal judge ruled the Food and Drug Administration overreached by stopping the shipments. There was then an appeal made by the Food and Drug Administration where they won a stay of ruling. Litigation will happen later this month as scheduled. Millions now use e-cig when waiting for the result. The industry estimates that one more 20,000 to 30,000 individuals start inhaling their vapors each and every week.
You can find more on this topic at these websites
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
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