E-Cigarettes Pose a Health Hazard, FDA WarnsLast Updated: July 23, 2009. Agency says testing shows devices contain carcinogens, other toxins.
By Steven Reinberg
WEDNESDAY, July 22 (HealthDay News) -- Testing of electronic cigarettes, known as e-cigarettes, has shown that they contain cancer-causing chemicals and other toxins, including a compound used in antifreeze, U.S. health officials said Wednesday.
E-cigarettes are battery-operated devices that contain cartridges filled with nicotine, flavorings and other chemicals. "The device turns nicotine, which is highly addictive, into a vapor that is inhaled," according to the U.S. Food and Drug Administration.
And these products could encourage smoking, the agency warned.
Dr. Joshua Sharfstein, FDA's principal deputy commissioner, said in a news conference Wednesday that "public health experts, including the World Health Organization, the U.S. Centers for Disease Control and Prevention and the American Cancer Society, have expressed concerns about the safety of these products and the risk that electronic cigarettes may increase nicotine addiction among young people and ultimately lead kids to try conventional cigarettes."
The FDA analyzed the ingredients in a small sample of cartridges from two brands of electronic cigarettes marketed by U.S. companies: NJOY, of Scottsdale, Ariz., and Florida-based Smoking Everywhere, according to Benjamin Westenberger, deputy director of the pharmaceutical analysis division at the Center for Drug Evaluation and Research, part of the FDA.
Although e-cigarettes are sold in the United States, they are manufactured overseas, mostly in China.
In one sample, analyses detected diethylene glycol, an antifreeze component. In several other samples, analysts found carcinogens, including nitrosamines, Westenberger noted.
"All of these results indicate an overall lack of quality control," he said. "These results indicate that these e-cigarettes could have safety and quality concerns."
The American Lung Association said that it supports the FDA's concerns. "For too long, e-cigarette manufacturers have sold these nicotine delivery devices -- absent FDA review and approval," the association said in a statement Wednesday. "These findings indicate FDA is serious about enforcing the law to protect consumers from unapproved products."
The lung association statement said that the group "urges the FDA to act immediately to halt the sale and distribution of all e-cigarettes unless the products have been reviewed and approved for sale by the FDA."
In addition to the testing, the FDA said it has been examining and detaining shipments of e-cigarettes at the border. So far, 50 shipments have been seized, according to Michael Levy, division director of the Office of Compliance at the Center for Drug Evaluation and Research.
But the battle over whether e-cigarettes are legal is just getting starting. The FDA contends that e-cigarettes are both a drug and a device, making them subject to U.S. government regulation under the Federal Food, Drug and Cosmetic Act. However, one of the companies that markets e-cigarettes, Smoking Everywhere, filed suit against the FDA in late April, claiming that the agency overstepped its authority by banning shipments and insisting that e-cigarettes go through the drug approval process, FDA officials said during the news conference.
A big concern of health experts is that e-cigarettes are marketed and sold to young people. The devices are available online and in shopping malls and could be a gateway to smoking actual cigarettes, they noted.
"It looks like a cigarette, and it's used like a cigarette," Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics' tobacco consortium, said during the news conference. "It's marketed as a cigarette, and thus has the potential to normalize and cue smoking behavior."
Winickoff noted that cartridges for e-cigarettes are available in flavors, including chocolate, mint and bubblegum. "Past experience suggests that these products may be particularly appealing to young people," he said.
"E-cigarettes might encourage children, preteens and young adults to take their first step toward smoking cigarettes," he said.
Representatives of NJOY released a statement Wednesday night defending the company's product.
"NJOY's products have been on the market since at least April 2007 with no reports of adverse health consequences," company CEO Jack Leadbeater said in a statement. "We do not market our products to children, and indeed take affirmative steps to ensure that our products are not sold to minors by requiring retailers to agree to where the product is placed and request verification of appropriate age as it pertains to each state law."
"NJOY has been tested by an independent third-party laboratory. This testing, as well as our consultation with medical experts, gives us confidence that our products are appropriate alternatives for traditional cigarettes for the committed smoker," Leadbeater continued. "We are therefore surprised the FDA's testing has resulted in the agency suggesting that our products represent a health risk on par with conventional cigarettes. We will provide more information on NJOY's testing and the results in the very near future."
Smoking Everywhere did not return phone calls seeking comment.
The U.S. Food and Drug Administration has more on e-cigarettes.
SOURCES: July 22, 2009, teleconference with: Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration; Benjamin Westenberger, deputy director, division of pharmaceutical analysis, Center for Drug Evaluation and Research, FDA; Michael Levy, division director, Office of Compliance, Center for Drug Evaluation and Research, FDA; Jonathan Winickoff, M.D., chairman, tobacco consortium, American Academy of Pediatrics; July 22, 2009, statement, NJOY
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