Oral Cancer News

Source: www.godanriver.com
Authors: David Ress & John Reid Blackwell, Media General News Service

Federal regulators are cracking down on a cigarette substitute that uses technology similar to devices that Philip Morris USA researchers have focused on in recent years.

Meanwhile, Virginia Commonwealth University is studying how much nicotine — the addictive compound in tobacco — the “electronic cigarettes” deliver, under a grant from the National Cancer Institute to look at nicotine products.

Since the start of the year, the Food and Drug Administration has issued “Import Alerts” advising staff working alongside U.S. Immigration and Customs Enforcement officers that they can seize “electronic cigarettes” made by three Chinese companies, federal court records show.

The FDA has refused to let at least 17 shipments of electronic cigarettes into the country, saying they are unapproved drug-delivery devices, spokeswoman Karen Riley said.

The devices are cigarette-shaped tubes that hold a heater that vaporizes a mix of nicotine and a kind of alcohol for the smoker to inhale. The nicotine and alcohol — usually propylene glycol, used as a moisturizers in cosmetics and in antifreeze — are contained in a replaceable cartridge inserted into the device, which also contains electronic controls that allow it to deliver a puff-of-smokelike dose of nicotine. The vaporizer and control units typically cost $100, while cartridges cost about $2 to $3 each and are supposed to be equivalent to a pack or two of cigarettes. Cigarettes routinely sell for more than $4.50 a pack in Virginia.

“The FDA is not aware of any data showing that these products are safe and effective” to be inhaled, Riley said, adding that the agency is “concerned about the potential for addiction to and abuse of these products, including addiction and abuse by young people.“

Jimi Jackson, owner of the No Smoke Virginia store on North Third Street in Richmond, thinks the agency is just trying to protect the tobacco and pharmaceutical industries, since it already allows other nicotine products and doesn’t control tobacco.

“Of course it’s safer,“ he said. “They’re trying to ban it when we know tobacco kills people every day . . .

“I was a smoker, smoked from when I was 15 ‘til I was 52. I found this product and I have not touched a tobacco product since,“ he said. “I tried everything, the gum, the patches, the pills, but nothing worked. This does because it gives you that hand-to-mouth thing — 90 percent of smoking is mental addiction.“

A sign in his store window promises: “Add 13 to 15 years to the life of a smoker. Safe for the smoker and those around them.“

Sonny Johnson, a dispather with the VCU police, said he’s been using the devices for a month, and has broken a 41-year smoking habit.

“They’re great,“ he said, as he stopped by Jackson’s store to pick up some refills.

Philip Morris USA, whose Richmond-based researchers have taken out several patents on devices that create fine mists for inhalers, as well as heating and electronic controls for inhalers, declined to comment on the FDA actions on electronic cigarettes.

Florida-based distributor Smoking Everywhere Inc., which says it has sold more than 600,000 electronic cigarette devices in the past year as alternatives to cigarettes, is challenging FDA action to seize devices it was importing last fall at the port of San Pedro, Calif., claiming the agency exceeded its authority.

“We’re not a smoking-cessation device, we’re not marketing it as a healthy alternative . . . this is an alternative for addicted smokers, said Matt Salmon, president of the Electronic Cigarette Association, a trade group.

Richard A. Daynard, a law professor and tobacco control expert at Northeastern University in Boston, said that the devices “encourage people to keep smoking. . . . They reduce the incentive to quit.“

Daynard is also concerned that electronic cigarettes, which often use sweet flavorings in their cartridges, will encourage nonsmokers, particularly young people, to experiment.

At VCU’s Institute for Drug and Alcohol Studies, Thomas Eissenberg is leading a study that began in 2004 of “potential reduced exposure products” for tobacco users — that is, items such as the electronic cigarette, nicotine tablets and snus, a Swedish-style moist snuff typically sold in small pouches, that claim to reduce the harm to nicotine users.

The study, which is still in progress, looks at the amount of nicotine users receive and what happens to it in their bodies.

Scott Ballin, a health policy consultant, says electronic cigarettes are one example of an emerging convergence between pharmaceutical nicotine products and traditional tobacco products.

“It has been around for about a year and a half in China, and I have been watching it and waiting for it to show up here,“ said Ballin, who works on behalf of public health and tobacco farmer interests lobbying Congress over FDA regulation of the tobacco industry.

Ballin said the current FDA legislation being debated in Congress isn’t well-equipped to deal with new products such as e-cigarettes.

Joel Spivak, a spokesman for the Campaign for Tobacco-Free Kids, said the product seems to be aimed at circumventing indoor smoking laws and luring smokers to a so-called alternative to cigarettes.

“The issue, at least as far as we are concerned, is safety, because nobody knows what is in them,“ he said. “They are obviously a nicotine delivery device, so the FDA has asserted authority over shipments coming into United States. Until such time as the FDA says that the vapor that these things emit is safe, we don’t see how anybody would want to ingest that stuff into their lungs.“