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Electronic cigarettes drug delivery devices need FDA authorization

The future of smoking is said to be with E-cigarettes, or e-cigs. The Food and drug administration wants to show a group of electronic cigarette businesses what that entails. The FDA has issued a warning to five electronic cigarette corporations for making unproven claims that e-cigs will help people quit smoking. Some of the e-cigarette businesses were singled out for unsafe manufacturing processes and adulterated products. Product from one of the e-cigarette manufacturers even contained weight loss and erectile dysfunction drugs. Until all products get Food and Drug Administration authorization with clinical trials, the e-cigarette companies are violating laws, states the agency.

As outlined by FDA, smokers do not get help quitting with electronic cigarettes

Thursday there were probably five angry electronic cigarette companies that found letters within the mailbox from the FDA. WebMD reports 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.” False claims of helping people quit smoking were made by all five companies, states the Food and Drug Administration. 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. E-cig firms have to do clinical trials when collecting data showing the electronic cigarettes are safe in order to get FDA approval, says WebMD. The companies that received FDA warning letters are:

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

Antifreeze in e-cigs

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. 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 Food and Drug Administration hasn’t received any application for authorization or evaluation from the businesses. It is waiting for the e-cigarette businesses to respond.

E-cigs popular

Electronic cigarettes emerged globally in 2002 and were touted as a safe alternative to tobacco cigarettes. USA Today explains when e-cigs really became popular. It was not until 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 ruled that the Food and Drug Administration 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. 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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