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As FDA Eyes E-cigarettes, Opinions Abound

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Marketing e-cigarettes in the U.S. has been a balancing act, and the biggest obstacles may still be ahead.

The Food and Drug Administration (FDA) has a few questions to answer. Are electronic cigarettes tobacco products or drug delivery devices? And a more subtle point, if a device helps smokers quit, is it necessarily a therapeutic drug?

As to the first point, the federal agency actually can’t say that e-cigs are therapeutic until the companies themselves make that claim. So far, the more than 200 companies that produce the e-cigs first exported from the Chinese market in 2005 claim their products are “smoking alternatives,” not “quit-smoking aids,” and have avoided drug regulation.

But that leaves the devices to be regulated as tobacco products, and advocates fear the FDA won’t recognize that many smokers use the devices to quit and will restrict their sales.

With all the deadlines and launch dates this October closing in, some may have missed the rumblings of a package of regulations that may, according to rumor, also be released in October. They could change the face of a burgeoning industry currently teetering in a unique, paradoxical space never before seen on the market.

Most industry analysts predict that kind of conservative ruling from the agency, but there’s an outside chance the government could decide that e-cigarette companies can explicitly market their products as quit-smoking aids, but not require the products to go through FDA drug approval.

Once the FDA issues an opinion, the public comment period and revisions could keep regulations from going into effect for a few more years.

What are e-cigarettes?

The battery powered tubular smoking devices release water vapor tinged with nicotine. They look like fountain pens, and the body of the “cigarette,” made of plastic or metal, is a permanent purchase. The units require a limited use cartridge full of liquid, which is vaporized by a heating element. When the cartridge runs dry, you replace it.

Also known as personal vaporizers or electronic nicotine delivery system, one brand’s starter kit for e-cigarettes (which includes a wall charger, USB charger, pack, and a set of five cartridges) costs $80. The “e-juice” cartridges typically contain propylene glycol, vegetable glycerin, polyethylene glycol and flavorings as well as nicotine.

About 21 percent of adults who smoke combustible cigarettes used e-cigarettes in 2011, according to the Centers for Disease Control and Prevention.

How do people use them?

Some insist people are already having success using e-cigs to quit smoking combustible cigarettes, which was, they say, the original intent of the products.

“Some consumers use e-cigarettes as a way to stop smoking and then to wean down and off nicotine altogether,” Elaine Keller of the Consumer Advocates for Smoke-Free Alternatives Association told HealthBiz Decoded by email. “Some consumers switch partially to e-cigarettes while continuing to smoke traditional cigarettes. As a rule, they tend to smoke fewer traditional cigarettes. From a health standpoint, this is preferable to exclusive smoking. In our experience, many of those who continue to smoke and use e-cigarettes for a period of time eventually transition to exclusive use of e-cigarettes.”

“My argument is that these show great promise as a smoking cessations strategy that may actually be more effective than what we have right now,” said Dr. Michael Siegel, professor of community health sciences at Boston University and electronic cigarette advocate.

Other nicotine replacement therapies have success rates of only about 10 percent for helping people quit, which is a “terrible success rate,” Siegel told HealthBiz Decoded.

“There’s clearly a large group of people who are just not able to quit using traditional methods,” he said. “The great thing about e-cigarettes is that they offer an alternative for those people.”

“Substituting smoke-free sources of nicotine for traditional cigarettes lowers health risks nearly as much as ‘quitting altogether’,” Keller said.

Since e-cigarettes involve vapor and not actual smoke from combustion, their use can’t really be called “smoking,” she said.

But the actual scientific literature supporting the effectiveness of e-cigarettes as quit-smoking aids is thin, and will continue to be until the products can explicitly be marketed that way, Siegel said.

As of July 2013, the World Health Organization stated there are no rigorous studies that indicate e-cigs are effective quit-smoking aids.

Meanwhile, some employers, like UPS, have started to impose extra coverage costs for employees who smoke e-cigarettes (a fee equal to that for other tobacco products), calling them “unsafe” and “carcinogenic.”

What are the health concerns?

The fact that e-cigarettes don’t produce smoke and don’t contain most of the chemicals found in combustible cigarettes may make them the lesser of two evils, but neither is a good idea, Ray Casciari, MD, FRCP, director of the thoracic oncology program and the chief medical officer at St. Joseph Hospital, in Orange, Calif., told Forbes this month.

Traditional cigarettes contain more than 60 known carcinogens, compared to two known carcinogens in some e-cigarettes, and international agencies warn that the health risks haven’t been fully studied yet.

Some worry that kids will pick up e-cigs and start smoking for the first time, but there’s no evidence that that has been happening yet, Siegel said.

Others point out that as long as the e-cigarettes are not regulated, there are no standards for what chemicals can and can’t be in the vapor, thus, some brands contain carcinogens while others do not. Often these differences are not clear to the consumer. No matter what the FDA opinion in October, proponents and opponents of e-cigs hope clear standards will be implemented to fix that problem.

How will they be regulated?

“The bottom line is you have to look at what is the overall public health impact these things are having,” Siegel said. “It’s pretty clear to me that the net impact is very positive.”

Advocates like Siegel and Keller are hoping the e-cigs will not be classified as pharmaceuticals, like nicotine gum or lozenges, but that doctors will let their patient know that the electronic cigarettes can be a useful tool.

That kind of lenient FDA opinion seems unlikely for now.

There does need to be more research on long-term health effects, but that shouldn’t keep smokers from using these products as quit-aids in the meantime, he said.

“Even though there are some questions about what the long term health risks might be from using e-cigarettes, there’s no question that they are safer than regular cigarettes,” he said. “We don’t need more research to answer that question.”

One Response to “As FDA Eyes E-cigarettes, Opinions Abound”

Vicky

These devices are smoking alternatives to traditional paper-based tobacco products. If these e-cigs help you stop the paper-based cigs then I guess they could be considered smiling cessation “devices”. This is really splitting hairs folks. The real question is what are the negative health impacts to e-cigs? We should certainly study this but in the meantime, if we have all concluded that they are lower risk than traditional tobacco products, which are not regulated drugs, then why bother to regulate e-cigs as drug? I smell a politico-economic agenda here……..