Monday, November 09, 2009

Smart Smoker e-cigarette: From China without regulation

In the past 2-3 days I've noticed advertisements for "smart smoker" in several of the media sources I read including the NYT.

I haven't seen anything like this for years. Heck, I'd thought these ads were disallowed in the US.

Turns out these are "e-cigarettes", a drug delivery system that's marketed as reducing second hand smoke and as "legal to smoke anywhere". They are currently legal to advertise in the US, but not legal to import.

They are manufactured in China, and first become popular in the UK, where they've emerged from a "regulatory gap". The vendor web sites strongly imply these are "safer" than traditional cigarettes; that's not implausible per nicotine dose unit but it's certainly untested. They don't claim that they're "safer" than bungee jumping.

So how does one figure out who's behind these expensive ads (and, as it turns out, huge lobbying, marketing and legal initiatives)? In this case, Google is not a friend. Simple searches turn up vast numbers of results from a mixture of pro-smoking groups, retailers and spam blogs. A smoke screen, as it were.

On the other hand, and PubMed have almost nothing on "e-cigarette" or "electronic cigarette". This has come on too quickly for public health and research to respond.

My best source to date has been a single June 2009 NY Times article, which I only found by restricting my Google search to That's where I learned this innovation was made in China. The "smoke" is inhaled propylene glycol, an antifreeze component (see also poisoned toothpaste (Chinese diethylene glycol). Emphases mine:
Cigarettes Without Smoke, or Regulation - June 2, 2009 -
FALL RIVER, Mass. — During 34 years of smoking, Carolyn Smeaton has tried countless ways to reduce her three-pack-a-day habit, including a nicotine patch, nicotine gum and a prescription drug. But stop-smoking aids always failed her.

Then, having watched a TV infomercial at her home here, Ms. Smeaton tried an electronic cigarette, which claimed to be a less dangerous way to feed her addiction. The battery-powered device she bought online delivered an odorless dose of nicotine and flavoring without cigarette tar or additives, and produced a vapor mist nearly identical in appearance to tobacco smoke.

... the Food and Drug Administration has already refused entry to dozens of shipments of e-cigarettes coming into the country, mostly from China, the chief maker of them, where manufacture began about five years ago. The F.D.A. took similar action in 1989, refusing shipments of an earlier, less appealing version, Favor Smoke-Free Cigarettes.

“These appear to be unapproved drug device products,” said Karen Riley, a spokeswoman for the agency, “and as unapproved products they can’t enter the United States.”

But enough of the e-cigarettes have made their way into the country that they continue to proliferate online and in the malls.

For $100 to $150 or so, a user can buy a starter kit including a battery-powered cigarette and replaceable cartridges that typically contain nicotine (though cartridges can be bought without it), flavoring and propylene glycol, a liquid whose vaporizing produces the smokelike mist. When a user inhales, a sensor heats the cartridge. The flavorings include tobacco, menthol and cherry, and the levels of nicotine vary by cartridge.

Propylene glycol is used in antifreeze, and also to create artificial smoke or fog in theatrical productions. The F.D.A. has classified it as an additive that is “generally recognized as safe” for use in food. But when asked whether inhaling it was safe, Dr. Richard D. Hurt, director of the Nicotine Dependence Center at the Mayo Clinic, said, “I don’t think so, but I’m not sure anyone knows for sure.”

Of the e-cigarettes themselves, Dr. Hurt added: “We basically don’t know anything about them. They’ve never been tested for safety or efficacy to help people stop smoking.”

Public health officials also worry that the devices’ fruit flavors, novelty and ease of access may entice children.

“It looks like a cigarette and is marketed as a cigarette,” said Jonathan P. Winickoff, an associate professor at the Massachusetts General Hospital for Children and chairman of the American Academy of Pediatrics Tobacco Consortium. “There’s nothing that prevents youth from getting addicted to nicotine.”

Sales and use of electronic cigarettes are already illegal on safety grounds in Australia and Hong Kong, and some other countries regulate them as medicinal devices or forbid their advertising. So far the United States has focused only on stopping them at the border, although Senator Frank R. Lautenberg, Democrat of New Jersey, has asked the drug agency to take them off the market until they can be tested.

Distributors of electronic cigarettes fear that a bill making its way through Congress that would give the F.D.A. the authority to regulate tobacco could be used to put them out of business as well. The bill has passed the House and could be taken up by the Senate this week.

The only American study of electronic cigarettes, now under way at Virginia Commonwealth University and financed by the National Cancer Institute, deals not with the kind of safety questions raised by propylene glycol but rather with the amount of nicotine processed by the bodies of the products’ users.

Another study, conducted this year at the University of Auckland in New Zealand and financed by Ruyan, an electronic cigarette company, shows that users typically receive 10 percent to 18 percent of the nicotine delivered by a tobacco cigarette...
So what we have here is a novel unregulated drug delivery system involving inhaled propylene glycol that is manufactured in China, a nation famous for the quality and regulation of its regulated Heparin supply. It is perfectly designed for sale to children and to Darwin award wannabes.

The good news is that the GOP no longer controls the FDA. That doesn't mean we can go back to sleep. The GOP will be back, and with Palin and Bachman in control it will be worse than ever. This beast needs to be driven back into its cage.

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Joseph P samms said...

A couple of points here, firstly I believe the FDA are being sued by a major importer for illegally holding their stock at ports and secondly, not sure if we should accept the views of Senator Lautenberg whilst he accepts large campaign donations from a maker of Nicotine patches, conflict of interest springs to mind. By the way, Propylene Glycol is also used in many cookies that we eat, and I have never heard of many actors dropping dead from exposure to it on stage.

John Gordon said...


Eating a banana - good.
Smoking a banana - not so good.

Vocal EK said...

Gordon: I smoked for 45 years. On two occasions I quit for as long as 6 months, but experienced cognitive impairments that did not resolve until I chose to resume smoking. Since nicotine-based drugs are now being developed for the treatment of Attention Deficit Disorder, Alzheimer's and Parkinson's that might give you a clue as to why nicotine abstinence causes these problems, and going back on nicotine resolves them. In March I began using an electronic cigarette and was able to completely stop smoking tobacco cigarettes. My wheezing has disappeared, I can laugh without breaking into a coughing jag, and my pre-hypertension has been replaced with BP of 117/79. I estimate that there are about 80,000 of us now in the same situation. What are we supposed to do if FDA pulls this life-saving product off the market? Resume smoking? Try to chew 20 pieces of nicotine gum a day? Apply for Social Security Disability?

John Gordon said...

Vocal, my health concern for perople like you isn't primarily about the nicotine delivery system. It's about using inhaled propylene glycol to make it look more like smoking.

Inhaled nicotine is well studied, though god alone knowns what's in unregulated nicotine capsules shipped from China (think melamine in dog food). Nobody has ever looked at inhaling propylene glycol. I'm betting it's toxic.

So if you're going to use an unregulated e-cigarette you're taking a big risk with whatever they call nicotine, but a REALLY big risk with the propylene glycol.

That's not considering, of course, the use of these systems to hook children on nicotine. That's where the real money is, not on the market of nicotine dependents over age 30.

Anonymous said...

Actually, many studies have been done on propylene glycol. It is listed as GRAS (generally recognized as safe) by the FDA. Here is one to get you started:

Here's a quote from that study: "General Toxicity Observations
Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed."

Stop fear mongering and do some real research.

John Gordon said...

Anoymous, those are EPA tests on animals. They are not comparable to the testing done for food and drug safety.

Denise G. said...

Propylene glycol is generally recognized as safe (GRAS) by the FDA. It is a common ingredient in many products, including medications commonly available OTC (Zyrtec, Motrin) as well as by prescription (cyclosporine, asthma/COPD inhalers). A simple wikipedia search shows a list of the numerous medical, food and cosmetic products (all subject to FDA approval) that contain PG. I doubt the FDA would allow the use of PG in inhaled medications if it was toxic. There is no proof that these items are marketed to children. They are marketed to adult smokers. You can chose to educate yourself or hide behind the children you claim to care about while their smoking parents continue to smoke deadly tobacco cigarettes.

John Gordon said...

This is the FDA statement on propylene glycol:

it refers to industrial or occupational exposures.

If you can find an FDA study of safety as a regularly inhaled drug carrier I will be interested.