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FDA Warns Makers of E-Cigarettes: 'You Need Approval'

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By Admin on September 10, 2010 7:12 AM

On September 9, the Food and Drug Administration issued letters to five companies and the trade organization involved in the manufacture and sale of electronic cigarettes or e-cigarettes. The warning letters from the FDA to the companies noted violations of the Federal Food, Drug, and Cosmetic Act including what the FDA says are "unsubstantiated claims and poor manufacturing practices." The letter to the Electronic Cigarette Association warned that FDA intends to regulate electronic cigarettes.

The FDA announced in a press release that it has determined that the e-cigarettes should be considered a drug product and will be regulated by the agency like any other product it oversees. Under the FDA approval process, a drug product must show that it is safe and effective for its intended use. A company must also prove that the manufacturing methods it uses can ensure the strength, quality and purity of the product.

Bloomberg reports e-cigarettes are metallic tubes containing a vaporized liquid version of a nicotine mixture. The e-cigarettes are made to look and feel similar to real cigarettes. The FDA's reason for exerting control over the industry stems from the claims made in the U.S. that the e-cigarettes can help smokers quit the real thing. The FDA goes on to state the companies should not claim they can help treat a "disease" such as nicotine addiction, unless the drug has been proven effective for this use. The FDA believes all five companies receiving letters have claimed the use of e-cigarettes can help smokers quit.

The agency cites additional concerns regarding the inclusion of unapproved drugs in some of the e-cigarettes, such as tadalafil (an erectile dysfunction drug) and rimonabant (a weight loss drug) in the refill cartridges of the E-Cig Technology products. The FDA also noted "deficiencies" in the manufacturing of the products from Johnson Creek Enterprises which markets Smoke Juice, the solution used to refill the e-cigarette cartridges.

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC.

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