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E-Cigarettes and the FDA – Raleigh Newspaper Article

June 18, 2009 By: admin Category: Articles, E-cig, Starter Packs

RALEIGH — As the government tightens regulations on tobacco and smoking, some people have found a new way to get their nicotine fix without smoke and ash: electronic cigarettes.

E-cigarettes, which deliver nicotine that users inhale along with a nearly odorless vapor-mist that mimics smoke, are practically unregulated and have not been rigorously tested in the United States. That doesn’t faze users such as David Moss.

Moss, 55, smoked traditional cigarettes for 40 years, but quit about six months ago after discovering a battery-operated version that provides the nicotine his body craves without the tar-filled smoke.

Moss, who lives in Durham and once smoked three packs a day, wasn’t bothered by the lack of studies on the e-cigarette.

“It’s unproven,” he said, “but I have no fear because I’m not smoking cigarettes.”

E-cigarettes are available online as well as in a number of gas stations and at least one mall in the Triangle.

Earlier this year the U.S. Food and Drug Administration began cracking down on the import of the devices, stopping shipments at the border. Most e-cigarettes are manufactured in China.

“Basically, we don’t have any data on these products,” said Karen Riley, an FDA spokeswoman.

E-cigarette starter kits can cost $100 or more. The cigarette, which is legal to possess, is often made of three pieces: a replaceable nicotine cartridge, an atomizer and a rechargeable battery. The cartridges come in a variety of flavors, including strawberry cheesecake, chocolate and tobacco, and nicotine-free versions are available. The atomizer, or heating element, warms when the user inhales and uses propylene glycol, a liquid used in theatrical smoke machines, to create the smokelike vapors.

The odor, nearly undetectable, is not immediately offensive to those nearby, the way cigarette smoke can be to nonsmokers.

Does FDA have a say?

President Barack Obama has said that he will soon sign legislation to give the FDA power to regulate tobacco. But that new law includes no guidance specific to electronic cigarettes.

North Carolina lawmakers recently passed their own smoking law — a ban on smoking in most bars and restaurants, starting next year.

N.C. Sen. William R. Purcell, who sponsored the legislation, said that he had not heard of e-cigarettes until last week. The law defines smoking in part as “any lighted tobacco product,” so Purcell thinks the new law, which takes effect Jan. 2, would not apply to e-cigarettes.

Former smokers such as Moss and his friend Wes Clark of Morrisville like the way e-cigarettes provide an experience akin to smoking a regular, or what they call an analog, cigarette. Nicotine gums and patches deliver the nicotine, but without the routine that comes with traditional smoking, said Clark, 37. After years of smoking, the behaviors that go with it, including stepping outside for a cigarette or watching the exhaled smoke, become a big part of the habit.

Unlike nicotine gums or patches, e-cigarettes have not undergone the clinical testing required for FDA approval. The agency thinks that e-cigarettes are a “drug-device combination product” and fall under its regulation, said Riley, the FDA spokeswoman.

One of the biggest American e-cigarette importers recently sued the FDA in an attempt to loosen the import restrictions.

For smokers only

Matt Salmon, a former Arizona congressman and current lobbyist who serves as president of the Electronic Cigarette Association, emphasized that his group specifically markets its product to committed smokers and only as an alternative to traditional smoking. Although some smokers say e-cigarettes have helped them quit smoking, the ECA does not claim its products can help people kick tobacco.

But “it’s clearly a product that doesn’t carry the known carcinogens that are in combustible tobacco,” Salmon said.

Jed Rose, director of the Duke Center for Nicotine and Smoking Cessation Research, said his lab has done some testing of e-cigarettes that focused on the way they deliver nicotine. E-cigarettes don’t deliver all the cancer-causing agents that tobacco cigarettes do, but it’s not clear exactly what they put in the user’s body.

When asked whether e-cigarettes were safer than tobacco-filled ones, Rose said the required studies have yet to be done: “That’s a tough question to answer without safety data.”

Moss and Clark met at a coffee shop last week with a couple of other e-cigarette fans to swap flavored nicotines and discuss their hobbies. Both men are concerned that e-cigs might eventually be taken off the market.

Moss said he used to spend more than $600 a month for cigarettes for himself and his wife. The e-cigarette habit costs only about $150. And because the vapor has almost no smell, he has smoked his e-cigarette in a movie theater as well as on an airplane.

If e-cigarettes are declared illegal, he said, “we’ll go underground like anything else.”

Article found at: http://www.thetimesnews.com/news/cigarettes-25890-smoke-nicotine.html

Electronic Cigarettes: Myths and Facts

June 03, 2009 By: admin Category: Articles

Electronic Cigarettes: Myths and Facts

Myth:  Electronic cigarettes are being sold to kids.
Fact:  Electronic cigarettes are intended for committed smokers of the legal age to smoke.

The industry advocates proper labeling, encourages retailers to check identification of customers and notes that electronic cigarette companies in good standing validate age prior to transacting online purchases. In a recent industry study that included a random sample of US electronic cigarette customers, the average respondent’s age was 44 years old. Further, with an average product price of about $100, it can hardly be called kid-friendly.

Myth:  Electronic cigarette cartridges offer many flavors in order to attract adolescent users.
Fact:  Many adult-intended products offer a variety of flavors.

The preference for flavor is universal and not age-specific. Products of all types offer colors, flavors and other variations in order to appeal to consumers. To suggest that the cartridge flavors for electronic cigarettes were devised to appeal to kids is patently false and has no basis in fact, and is the same thing as suggesting nicotine-infused smoking cessation gums are available in mint and cinnamon flavors in order to appeal to kids. Electronic cigarettes sold by companies in good standing are for committed smokers of the legal age to smoke.

Myth:  Electronic cigarettes make nicotine readily available to non-smokers.
Fact:  Electronic cigarettes are marketed to current smokers, not non-smokers.

Nicotine is widely available in over-the-counter products including tobacco cigarettes and smoking cessation gums and lozenges, and there is no evidence that these products or electronic cigarettes increase the consumption of nicotine by those who do not wish to smoke. In a recent industry study that included a random sample of US electronic cigarette customers, 96% were smokers purchasing the product for personal use, and 4% purchased the product for a friend or relative who smoked.

Myth:  No one knows what is in electronic cigarettes.
Fact:  Multiple studies have been conducted and the ingredients are well known.

Multiple studies by different laboratories around the globe have been conducted identifying that the vapor that is ingested when using an electronic cigarette, depending on the manufacturer,  contains approximately 20 ingredients including nicotine, all regarded as generally safe for human consumption when ingested prudently and in accordance with proper labeling. By contrast tobacco smoke contains 4,000 ingredients including arsenic and carbon monoxide, and dozens of cancer-causing ingredients.

Myth:  Electronic cigarettes cannot be legally marketed in the US.
Fact:  The FDA has not issued any formal guidance on electronic cigarettes.

While it is true that some manufacturers have had the importation of their products stopped, it is also true that the FDA has only provided informal comments about electronic cigarettes through its spokespeople and has not issued any formal guidance on the topic. FDA currently only has jurisdiction to regulate drugs and medical devices, and electronic cigarettes are neither.

Myth:  You can stop people from smoking.
Fact:  Tobacco smoking increased in the US in 2008 for the first time since 1965.

After a 30-year decline in tobacco smoking in the U.S., the percentage of US adults who smoke tobacco increased in 2008 and for the first time since 1965; this despite decades of gallant legislative and educational efforts, and the multi-billion dollar smoking cessation market. It is clear that some people will choose to smoke, and that further improvement in public health requires the acceptance of this reality and the full embrace of innovative new products that are ever-less hazardous than tobacco cigarettes and ever-more effective than abstinence.

Myth: Nicotine is bad for you.
Fact: The long-term use of nicotine is orders of magnitude safer than tobacco smoking.

Nicotine suffers from guilt-by-association with tobacco. The carcinogenic properties of nicotine in a standalone form, separated from tobacco smoke, indicate that nicotine, on its own, does not promote the development of cancer in healthy tissue and has no mutagenic properties. Further, the Royal College of Physicians says that there are no grounds to suspect appreciable long-term adverse effects on health from the long-term use of nicotine. Electronic cigarette companies in good standing and with proper labeling do advise consumers on who the product is intended for and who should not use the product, as well as the addictive qualities of nicotine.”

From the Electronic Cigarette Association http://www.ecassoc.org/resources/myths-and-facts/