Food and Drug Administration approval needed on e-cigs as drug delivery devices

E-cigs are the electronic cigarettes that are called the future of smoking. The Food and drug administration wants to be part of the action. It hopes to tell e-cigarette companies what it entails. The FDA has issued a warning to five electronic cigarette companies for making unproven claims that e-cigs will help individuals quit smoking. Some of the e-cigarette corporations were singled out for unsafe manufacturing processes and adulterated products. Product from one of the electronic cigarette manufacturers even contained weight loss and erectile dysfunction drugs. The organization explained that laws are being violated by the corporations until the FDA has done clinical trials in order to approve the drug delivery products.

FDA states e-cigs won’t stop you from smoking

Thursday there were probably five angry electronic cigarette businesses that found letters within the mailbox from the Food and Drug Administration. The letters explained, as outlined by 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.” False claims of helping people quit smoking were made by all five businesses, states the FDA. The e-cig is legally defined as a drug delivery machine, states the Food and Drug Administration. In a letter to the E-cigarette Association, it stated the e-cigs need approval 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. The corporations that received FDA warning letters are:

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

E-cigs and antifreeze

The FDA has done testing of its own 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. Unlike tobacco cigarettes and FDA-approved nicotine patches and gum, e-cigs have no health warnings on the packaging. The FDA has not received any application for authorization or evaluation from the corporations. It is waiting for the e-cigarette businesses to respond.

Numerous use e-cigs

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, says USA Today. The country was not allowed to accept any more electronic cigarettes which were imported. The Food and Drug Administration made sure customs officials knew. A federal judge ruled the FDA 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. The result will affect millions. Millions use the e-cig. The industry estimates that another 20,000 to 30,000 people start inhaling their vapors each week.

Find more details 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