Agency States Electronic Cigarettes Require Food And Drug Administration Approval As Substance Distribution Devices
Friday, September 17th, 2010E-cigs are the e-cigarettes that are known as the future of smoking. What that entails is something the FDA hopes to be able to show e-cigarette corporations. Five electronic cigarette corporations have claimed electronic cigarettes will help many quit smoking which the Food and Drug Administration has issued warnings for. Unsafe manufacturing processes and adulterated products was what some of the e-cigarette corporations were said to have been doing. Interesting drug was found in the product at one of the e-cigarette corporations. There were drugs for weight loss and erectile dysfunction. The drug delivery devices are violating law, states the Food and Drug Administration. Until the Food and Drug Administration has done clinical trials and given its approval, this will be the case. Source for this article – Agency says electronic cigarettes need FDA approval as drug delivery devices by Personal Money Store.
FDA says e-cigs don’t help smokers quit
Thursday there were probably five angry electronic cigarette businesses 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. 15 working days were given by the FDA for them 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 companies, says the FDA. The e-cig is legally defined as a drug delivery system, says the FDA. In a letter to the E-cigarette Association, it stated the e-cigs need authorization before being sold. E-cig firms have to do clinical trials while collecting data showing the electronic cigarettes are safe in order to get FDA approval, states WebMD. Businesses with FDA warnings are:
- Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
- Then there’s E-Cigarette Direct LLC, Parker, Colo.
- Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
- Johnson Creek Enterprises LLC, Johnson Creek, Wis.
- Last is Ruyan America Inc., Minneapolis, Minn.
With e-cigs you inhale antifreeze
Tests were done by the FDA. These tests were on electronic cigarettes. 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. E-cigs don’t have any warnings about health on the package like tobacco cigarettes and FDA-approved nicotine patches and gum have. The FDA has not received any application for authorization or evaluation from the corporations. It is waiting for the e-cigarette businesses to respond.
E-cigs wanted by many
Electronic cigarettes emerged globally in 2002 and were touted as a safe choice to tobacco cigarettes. Electronic cigarettes didn’t really get started until 2006 though, states USA Today. The country was not allowed to accept any more e-cigs that were imported. The Food and Drug Administration made sure customs officials knew. 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.
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