E-Cigarettes Illegally Marketed,
Are Unapproved Drugs, FDA Letters Say
By - Sep 9, 2010
Electronic cigarettes sold in the U.S. are being marketed illegally as smoking-cessation aids, the Food and Drug Administration said.
E-cigarettes and related products sold by five closely held companies are unapproved new drugs and devices because they’re promoted as a way to help smokers stop or reduce their use of regular cigarettes, the FDA said in warning letters posted today on the agency’s website. To sell the products, companies must conduct animal and human studies, and submit an application to the FDA, the agency said in a separate letter to the Electronic Cigarette Association, a Washington-based industry group.
E-cigarettes, which mimic the appearance of traditional cigarettes, are metallic tubes filled with a vaporized liquid nicotine mixture. The FDA in February won a temporary delay of a U.S. judge’s ruling that the agency lacks authority to regulate the products as drug devices and must allow them to be imported. The case is scheduled for a Sept. 23 hearing.
“In the interest of protecting the public health, the FDA will take a reasonable and measured approach to the regulation of electronic cigarettes,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in yesterday’s letter to the Electronic Cigarette Association.
A representative of the cigarette association could not be reached for comment.
The warning letters were sent to Gamucci America Inc. in Jacksonville, Florida; E-Cig Technology Inc. in Las Vegas; Ruyan America Inc. in Minneapolis; Johnson Creek Enterprises LLC in Johnson Creek, Wisconsin; and E-CigaretteDirect LLC in Parker, Colorado.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
- [ Courtesy Molly Peterson ]
E-cigarettes and related products sold by five closely held companies are unapproved new drugs and devices because they’re promoted as a way to help smokers stop or reduce their use of regular cigarettes, the FDA said in warning letters posted today on the agency’s website. To sell the products, companies must conduct animal and human studies, and submit an application to the FDA, the agency said in a separate letter to the Electronic Cigarette Association, a Washington-based industry group.
“In the interest of protecting the public health, the FDA will take a reasonable and measured approach to the regulation of electronic cigarettes,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in yesterday’s letter to the Electronic Cigarette Association.
A representative of the cigarette association could not be reached for comment.
The warning letters were sent to Gamucci America Inc. in Jacksonville, Florida; E-Cig Technology Inc. in Las Vegas; Ruyan America Inc. in Minneapolis; Johnson Creek Enterprises LLC in Johnson Creek, Wisconsin; and E-CigaretteDirect LLC in Parker, Colorado.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
- [ Courtesy Molly Peterson ]
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