UPDATE: FDA Warns Five E-Cigarette Makers, Says Products Need FDA Approval
September 09 2010 - 3:03PM
Dow Jones News
The U.S. 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 Creek Enterprises
LLC of Johnson, Wis.
The Electronic Cigarette Association, which represents
e-cigarette companies, didn't immediately return a call for
comment. The five companies represent a small portion of the
estimated 300 firms that make or distribute electronic
cigarettes.
The FDA said it 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.
The companies have 15 days to respond to the FDA.
Michael Levy, director of labeling compliance for FDA's drug
division, said the agency would wait to see what the company
responses were before deciding what to do next.
The agency could act to remove the products from the market but
it would likely involve a court fight.
FDA is already involved in a separate lawsuit with other
e-cigarette companies that involves the agency's jurisdiction over
the products. In 2008 the FDA started detaining some shipments from
China on the grounds that they were unapproved drug devices.
Levy said the FDA cannot discuss that lawsuit.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
