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'E-cigarettes,' intended to help smokers quit, have a hazy future

Irving banker Keith Temple says he wants to quit smoking before the U.S. Food and Drug Administration bans the product helping him beat traditional cigarettes.

After smoking for nearly 40 years and building a two-pack-a-day habit, Temple said he has cut back to about 10 tobacco cigarettes a day by "vaping" electronic cigarettes when he gets the urge to light up. For the past month, Temple said, he has been using the so-called e-cigarettes in his office. They mimic tobacco cigarettes by giving off a vapor.

"I got some looks [from co-workers] the first time," he said. "But once I explained it, they were fine with it. They thought that anything that would keep me from smoking was a good thing."

The FDA isn’t so sure.

The agency said Wednesday that an analysis of 19 e-cigarette components distributed by two of the products’ leading marketers show that there are dangers to using them. The analysis found that half the samples contained cancer-causing agents and at least one contained diethylene glycol, an ingredient in antifreeze.

It’s unclear whether the announcement will bring a broader crackdown against e-cigarette distributors, which have been selling the products to U.S. smokers for about four years. The FDA has intercepted 50 shipments of e-cigarettes and product components, 17 of them since March. Most of the products are made in China.

"I think the bottom line here is simple," said Jonathan Samet, director of the University of Southern California’s Institute for Global Health, during a news teleconference Wednesday. "These are devices of delivering nicotine through unknown magnitude into the body with no proven benefit for cessation and some indication that there may be risks."

Kyle Newton, president of SS Choice Llc., an online e-cigarette marketer in Colleyville, said he worries that he will run out of stock and not be able to supply his customers because of the FDA’s actions.

"We’d like to get a fair opportunity to market our product and stay in business," Newton said. "They may not be 100 percent safe, but they are way safer than a tobacco cigarette, according to lab studies. You shouldn’t just slam the hammer down on this product because it’s affecting your tax revenue."

The FDA has labeled e-cigarettes as unapproved drug-delivery devices. Regulators say the products must be evaluated for safety and go through the same approval process as other nicotine-delivery devices, such as patches, inhalers and gums.

Some distributors have not submitted their products to the FDA for approval because they do not agree that e-cigarettes should be regulated as though they are new pharmaceutical inventions, according to the Electronic Cigarette Association. Some product advocates say the government is acting as a proxy for corporations that see e-cigarettes as a competitor to their smoking-cessation products.

"This appears to be less about public health than it is about public relations," said Matt Salmon, president of the Washington, D.C.-based group. "I believe there are some special interests that are motivating this. There is a pending lawsuit. I wonder if they are playing to the judge."

The FDA’s analysis, dated May 4, reviewed products from Njoy and Smoking Everywhere, e-cigarette distributors that are suing the FDA to prevent the government from seizing their products.

FDA officials say they’ve been unable to conclude whether e-cigarettes are safer or deadlier than traditional tobacco cigarettes. Some health experts are concerned about the nicotine dose delivered by the devices and whether the products might be attractive to children because many include flavorings.

Nicotine can raise blood pressure, cause strokes and harm those with underlying health conditions. People cannot go into the store and buy nicotine, said Barry Johnson, a Fort Worth respiratory therapist and a volunteer with the American Lung Association.

"The FDA is not sure these things do what they say, and we want to make sure we know before we release these things to the public," Johnson said. "This is done with all types of medical devices. When you deal with the government, you deal with them on their terms, not yours."

E-cigarette marketers also worry that the Family Smoking Prevention and Tobacco Control Act, signed by President Barack Obama on June 22, could put the industry out of business by expanding government authority over tobacco products.

If the FDA decides to regulate e-cigarettes by the same standard it has set for new medical devices, that could involve clinical trials costing millions of dollars.

"If the FDA tries to make us go through the same process that drug devices go through, it will probably kill the industry," Salmon said.

By the numbers The e-cigarette industry is expected to generate more than $100 million in revenue this year.

Texas has 53,000 tobacco-related deaths each year at a cost of $3.5 billion.

Tobacco cigarettes contain tars and about 4,000 other chemicals; about 60 are known carcinogens.

In the U.S., cigarettes directly cause 400,000 deaths annually and 30,000 more by secondhand smoke.

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