E-cigs substance delivery products need FDA authorization

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E-cigs substance delivery products need FDA authorization

Post by NiveaA on Wed Sep 22, 2010 6:15 am

The future of smoking is said to be with Electronic cigarettes, or e-cigs. E-cigarette companies may have to sit and listen while the FDA explains what that entails. The FDA is mad that five of the electronic cigarette companies claimed e-cigs will quit smoking in advertising. False advertising wasn't the only thing the e-cigarette corporations were doing. Some had unsafe manufacturing processes and adulterated products as well. Interesting drug was found in the product at one of the electronic cigarette corporations. There were drugs for weight loss and erectile dysfunction. Until all products get FDA approval with clinical trials, the e-cigarette businesses are violating laws, says the organization. Article source - Agency says electronic cigarettes need FDA approval as drug delivery devices by Personal Money Store.

FDA says electronic cigarettes will not stop you from smoking

Thursday there were probably five angry electronic cigarette businesses that found letters in the mailbox from the FDA. E-cig firms were warned in the letters that their product is violating substance safety laws. This came 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 electronic cigarettes help people quit smoking. In a separate letter to the Electronic Cigarette Association, the FDA said e-cigs are legally defined as drug delivery devices and need agency approval to be sold. 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. The companies that received FDA warning letters are:
  1. There's Cixi E-Cig Technology Inc. Ltd., Las Vegas, Nev.
  2. Then there's E-Cigarette Direct LLC, Parker, Colo.
  3. Next is Gamucci America/Smokey Bayou Inc., Jacksonville, Fla.
  4. Fourth is Johnson Creek Enterprises LLC, Johnson Creek, Wis.
  5. Ruyan America Inc., Minneapolis, Minn.

Inhaling antifreeze from e-cigs

The FDA conducted electronic cigarette tests. Med Page Today showed some tests the Food and Drug Administration published in June on the e-cigs. These tests showed that carcinogens such as nitrosamines and also the poisonous ingredient in antifreeze, diethylene glycol, are both in e-cigarettes. There are warnings about health on all tobacco cigarettes and FDA-approved nicotine patches and gum. Electronic cigarettes 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 firm for evaluation or approval.

Numerous have e-cigs

The "safe" option to tobacco cigarettes, e-cigs, came out at first in 2002. E-cigs didn't really get began until 2006 though, states USA Today. The country wasn't allowed to accept any more electronic cigarettes that were imported. The Food and Drug Administration made sure customs officials knew. A federal judge ruled that the FDA overreached by stopping the shipments. 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. 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

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NiveaA

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