Organization says e-cigs require Food and Drug Administration authorization as substance delivery devices

E-cigs are the electronic cigarettes that are known as the future of smoking. The FDA wants to show a group of electronic cigarette corporations 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. False advertising wasn’t the only thing the e-cigarette companies were doing. Some had unsafe manufacturing processes and adulterated products as well. One of the e-cigarette manufacturers had drugs for impotence problems and weight loss in its product. The agency explained that laws are being violated by the companies until the Food and Drug Administration has done clinical trials in order to approve the substance distribution devices.

FDA says e-cigs do not help smokers quit

Thursday there were probably five angry electronic cigarette companies that found letters within the mailbox from the Food and Drug Administration. E-cig firms were warned in the letters that their product is violating drug safety laws. This originated from WebMD. The FDA has given them 15 working days to revise “practices which violate various provisions of the Federal Food, Drug and Cosmetic Act.” The FDA said all five companies falsely claim their e-cigs help individuals quit smoking. The FDA sent an additional 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. 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. As follows are the companies with FDA 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. Next is Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
4. Johnson Creek Enterprises LLC, Johnson Creek, Wis.
5. Last is Ruyan America Inc., Minneapolis, Minn.

E-cigs contain antifreeze

The FDA has done testing of its own on electronic cigarettes. Med Page Today reports that in June the agency published results of lab tests showing e-cigarettes contain carcinogens including nitrosamines and diethylene glycol, a poisonous ingredient in antifreeze. 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 said no e-cigarette business has yet submitted an application to the agency for evaluation or approval.

E-cigs popular

The “safe” choice to tobacco cigarettes, e-cigs, came out at first in 2002. USA Today reports that e-cigs made their first splash within the United States of America in late 2006. The country wasn’t allowed to accept any more electronic cigarettes that were imported. The FDA 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. Millions now use e-cig when waiting for the result. Each and every week the industry expects 20,000 to 30,000 new customers.

Further 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