Electronic cigarettes don't contain tobacco or tar, but a Florida company is fighting for its high-tech substitutes to be identified as tobacco products, not drugs.
Why struggle to be grouped with a product vilified for killing millions of people each year? At least for Smoking Everywhere Inc., it would be a step up from having its product regulated as a drug.
Smoking Everywhere distributes e-cigarettes
, which can't be lit and don't have tobacco. They are battery-operated and contain cartridges filled with nicotine, flavor and other chemicals. The steel tube that is made to look like a cigarette turns nicotine and water into a vapor that is inhaled.
Company representatives will be in Washington, D.C., on Aug. 17 for a hearing in federal district court to challenge the U.S. Food and Drug Administration, which wants e-cigarettes labeled as drug devices under its jurisdiction.
has not approved e-cigarettes as safe and has seized shipments being imported into the country.
Smoking Everywhere filed a lawsuit against the federal agency in April and sought a restraining order claiming that the FDA
doesn't have the authority to control its products.
"It is an electronic cigarette, and a cigarette is not designed to stop someone from smoking ... so practically speaking, it would not fall under the definition of a drug," said Walt Linscott, a lawyer for Smoking Everywhere.
Smoking Everywhere and another e-cigarette company, NJoy, which is a plaintiff in the suit, have had about 50 shipments confiscated by the FDA
, Linscott said.
Smoking Everywhere imports all its cigarettes from China. With shipments not able to pass through U.S. Customs, its distributors will eventually run out, he said.
asserts it is protecting consumers. Right now, it's unclear how e-cigarettes would affect users' health, said Judy Leon, an FDA
"It is important for the American people to know what is in electronic cigarettes in terms of the chemicals and the dose of nicotine," Leon said.
In a court filing, the FDA
proposes that e-cigarettes fall in the category of drug devices as defined in the Federal Food, Drug and Cosmetic Act. They are designed, the FDA
argues, to help in the treatment of nicotine addiction, which some medical experts have labeled a disease.
No matter how the companies market the product, e-cigarettes deliver nicotine, so the FDA
has the authority to regulate them, Leon said. Smoking Everywhere claims that unlike nicotine gums and transdermal patches that the FDA
regulates, its e-cigarettes are a safer alternative to smoking, not necessarily a means to quit smoking.
"A regular cigarette has no therapeutic value. ... It's not designed to provide a health benefit. It's quite the opposite," Linscott said.
David Drobes, a researcher who works in the Tobacco Research and Intervention Program at the Moffitt Cancer Center in Tampa, Fla.said that if e-cigarettes are not regulated now, the public may regret it later.
"If history proves anything, it is that companies that say they offer safer cigarettes really don't have the data to support that," he said, referring to light cigarettes advertised to have less tar and nicotine, claims that health advocates say are misleading.
announced July 22 that a laboratory analysis of e-cigarettes found that they contain carcinogens and toxic chemicals such as diethylene glycol, used in antifreeze.
Matt Salmon, president of the Electronic Cigarette Association, criticized the report as too narrow in scope and for not including a peer review.
"My personal feeling is that it was a lot more about public relations than public health," Salmon said.
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