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Electronic cigarette makers seek to keep devices out of the FDA's control

Electronic cigarettes don't contain tobacco or tar, but a South Florida company is fighting for its high-tech substitutes to be identified as tobacco products.

Why struggle to be grouped with a product vilified for killing millions of people each year? At least for Smoking Everywhere Inc., it's 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.

The FDA 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.

The FDA asserts it is protecting consumers. Right now, it's unclear how e-cigarettes would affect users' health, said Judy Leon, an FDA spokeswoman.

"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, 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.

The FDA 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.

If Smoking Everywhere won the lawsuit and became part of the big boys' club of tobacco companies, it still would face rough waters.

At the end of June, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act to create stricter tobacco regulation.

Despite this legislation, Linscott said Smoking Everywhere is ready to face the challenges of being a tobacco company.

"If we are correct that it is a tobacco product, we are subject to all of the limitations and regulations of Marlboro and any other traditional cigarettes that you can name," he said.

FAST FACTS

Tobacco roadblocks

If e-cigarettes are found to be tobacco products, here are some ways the Family Smoking Prevention and Tobacco Control Act could pose some issues for Smoking Everywhere:

• By October, tobacco companies will no longer be able to make candy- or fruit-flavored cigarettes. Smoking Everywhere has different flavors of cartridges such as vanilla and strawberry.

• Tobacco manufacturers may no longer sponsor sporting, athletic and entertainment events using tobacco product brand names and logos. This year Smoking Everywhere sponsored several large entertainment events, including the 40th annual NAACP Image Awards, the Grammy Awards and the Oscars.

• A new Center for Tobacco Products will oversee the science-based regulation of tobacco products, which would ultimately put the control of tobacco products in the FDA's hands.

Electronic cigarette makers seek to keep devices out of the FDA's control 08/05/09 [Last modified: Friday, August 7, 2009 7:57pm]
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