FDA Warns E-cigarette Distributors
The U.S. Food and Drug Administration (FDA) issued a stern warning to distributors of electronic cigarettes, accusing them of violating rules for unsubstantiated claims and employing poor practices in manufacturing their products.
E-cigarettes are battery-operated gadgets with cartridges that contain nicotine and other substances. The FDA said that distributors falsely advertise that their products help people quit smoking.
“The device turns nicotine, which is highly addictive, into a vapor that is inhaled,” the FDA said in a news conference on Thursday.
“These products are not proven safe and effective yet,” Michael Levy, director of the division of new drugs and labeling compliance in the Center for Drug Evaluation and Research of the FDA.
The agency cites tests made in July which found that some e-cigarettes contain chemicals which can cause cancer, including a compound used in antifreeze.
One e-cigarette company was caught selling unapproved weight loss and erectile dysfunction drugs as refills for the devices' cartridges.
The FDA points out that consumers should buy “FDA-approved smoking cessation aids on the market.”
Those who were issued warning notices were E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc., and Johnson's Creek Enterprises LLC.
Levy said that the FDA is still in the process of testing the safety and effectiveness of e-cigarettes.
“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the agency wrote to the Electronic Cigarette Association.