The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.
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Electronic cigarette have not been evaluated by the FDA for safety and effectiveness.
The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.
Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.
“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.
Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.
The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.
“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.
In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.
Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.
The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.
The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.
“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.
“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.
For further information, see the FDA’s full analysis of e-cigarettes.