FDA Warns E-Cigarette Cos. Over Unapproved Products

Law360, New York (September 9, 2010, 7:30 PM EDT) -- The U.S. Food and Drug Administration has taken enforcement action against five electronic cigarette distributors that have failed to gain proper regulatory approval for products branded as drugs under the Federal Food, Drug and Cosmetic Act.

The FDA issued warning letters to E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America, E-Cig Technology Inc. and Johnson Creek Enterprises LLC on Thursday, citing various violations of the FDCA including making unsubstantiated claims, engaging in poor manufacturing practices and using the devices as delivery mechanisms for active pharmaceutical ingredients....
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