Electronic cigarettes sold in the U.S. are being marketed illegally as smoking-cessation aids, the Food and Drug Administration says. E-cigarettes and related products sold by five closely held companies require approval as drugs or medical devices because they’re promoted to help smokers stop or reduce use of regular cigarettes like Marlboro, Camel and other brands the FDA said.
To sell the products, companies must conduct animal and human studies and apply for FDA clearance, the agency said in a separate letter to the Electronic Cigarette Association, a Washington-based industry group.
E-cigarettes are metallic tubes filled with a vaporized liquid nicotine mixture. While the devices mimic the look and feel of traditional cigarettes, they don’t contain tobacco or produce smoke. 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 drugs or medical devices and must allow them to be imported. The case is scheduled for a hearing Thursday.
”Although these products are frequently marketed to help consumers quit smoking, the FDA has not evaluated them for safety or effectiveness,” said Michael Levy, director of the agency’s Division of New Drugs and Labeling Compliance.
The warning letters were sent to Gamucci America in Jacksonville, Fla.; E-Cig Technology Inc. in Las Vegas; Ruyan America Inc. in Minneapolis; Johnson Creek Enterprises LLC in Johnson Creek, Wis., and E-CigaretteDirect LLC in Parker, Colo.
The companies have 15 days to respond.
The FDA will evaluate those responses before deciding whether the products should be taken off the market, Levy said.
The FDA should hold e-cigarettes to the same standards for safety and effectiveness as other drugs, including nicotine-replacement therapies, said Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids, in Washington.
Smoking-cessation products approved by the FDA include prescription nasal sprays and over-the-counter gums, patches and lozenges.
GlaxoSmithKline Plc’s Nicorette gum was the top-selling brand-name nicotine-replacement drug for the year ended in June, with $144.6 million in sales, or 12 percent of the $1.2 billion smoking-cessation market, according to IMS Health Inc., a research company in Norwalk, Conn.