FDA Warns Five E-Cigarette Makers, Says Products Need FDA Approval

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Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration warned five electronic cigarette makers Thursday that they were violating federal law.

The agency said the products, which use a device to turn nicotine liquid into a vapor mist, are drugs that require pre-market approval similar to other nicotine replacement products. The FDA recently started regulating traditional cigarettes under a separate tobacco law.

The FDA said the e-cigarette companies are marketing their products as tools to help people quit using cigarettes. The agency suggested the companies would need to conduct clinical studies showing the products are an effective treatment for nicotine addiction.

The companies receiving warning letters are E-CigaretteDirect LLC of Parker, Colo.; Minneapolis's Ruyan America Inc.; Gamucci America, also known as Smokey Bayou Inc., of Jacksonville, Fla.; E-Cig Technology Inc. of Las Vegas and Johnson's Creek Enterprises LLC of Johnson, Wis.

The FDA also cited Johnson Creek Enterprises, which markets Smoke Juice, a liquid solution used to refill depleted cartridges in e-cigarettes, for deficiencies in its manufacturing processes and cited E-Cig Technology for using tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that's not approved for use in the U.S., in some of its products.

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