Wednesday, March 3, 2010

NRT versus Smoking Substitute

In response to pressure from many groups, the FDA wants to regulate electronic cigarettes as a drug-delivery device. This approach would remove the products from the market until (if ever) clinical trials proved them to be “safe and effective.”

In the FDA world, the disease being treated is nicotine dependence (305.1). One approach to treating that diagnosis is "nicotine reduction therapy" (NRT). The "R" is supposed to stand for "replacement", but there really is no intention of replacing the nicotine in sufficient quantities long-term in the same way that thyroxin or estrogen is replaced, so "reduction" is a more accurate word to use in the acronym NRT.

Currently available NRT products have worked for a number of people; but in the long-term, they don't work for 9 out of 10 people. It’s a positive thing that researchers are interested in studying the "e-cigarette" as a potential NRT. Quite a few e-cigarette users have reported that they have been able to titrate down to "no-nic" liquid with a great deal of ease. So perhaps the e-cigarette will prove to be as effective, or more effective, than other forms of NRT. But if e-cigarettes are required to parallel the design of other NRTs, the nicotine dosage would be reduced to well below the amount delivered by smoking. The products would also need to be accompanied by directions for reducing the amount used over time to zero.

That takes care of the smokers who want to be free of nicotine. But a goodly percentage of smokers are unable or unwilling to stop using nicotine, because nicotine is helping them to control cognitive deficits, mood impairments, chronic pain (e.g. fibromyalgia), chronic fatigue, and/or side effects of other medications. And until recently, the most effective way to take in sufficient nicotine to control these problems was by inhaling tobacco smoke.

What if it were possible to convince a large percentage of this latter group to substitute inhaling vaporized nicotine for inhaling combusted tobacco smoke? In this case we would not be "treating" the nicotine addiction, but rather would be removing several devastatingly harmful ingredients from the inhaled substance (i.e., tar, CO, particulates, heavy metals, thousands of toxins, and hundreds of carcinogens.) We would be allowing the product's users to regain or preserve their physical health without requiring them to sacrifice their cognitive and/or emotional health.

Well, it is possible. It is happening. Thousands of e-cigarette users are reporting improvements in their lung health and markers of cardiovascular health. Why in the world would anyone want to tell these former smokers: "Go back to smoking -- or switch to the NRT products that didn’t work for you before"?

The FDA does not need to be "in a pickle" about regulating e-cigarettes for safety or efficacy. If they don't work as substitute for smoking, consumers will just not use them. It's that simple. Efficacy problem solved.

The FDA already has the power to regulate e-cigarettes for safety. Judge Leon has ruled that e-cigarettes are a tobacco product. The law permits the FDA to regulate tobacco products. The FDA can require that labs that produce e-cigarette liquid conduct regular testing and post the results for public viewing. The FDA can specify the maximum allowable amounts of TSNAs. The FDA can require child-proof packaging. The FDA can require labels that provide complete information about ingredients and quantities.


  1. Very good article and right on the money.

    Nicotine is the commodity some of us enjoy but it doesn't treat a medical condition, it only prolongs 'addiction'.

    I suspect that in the States you do already have regulations that govern the commercial market and the nicotine products on it for safety as well as truthful advertising and appropriate packaging.

    Tobacco classification may be unnecessary, enforcement of existing laws and an introduction of measures to protect young people from toxic and addictive substances should be sufficient. The picture doesn't look good for the future of tobacco nicotine, health campaigners plan to have levels gradually reduced to be ineffective and to secure the market for pharm companies.

    If the market does get closed by defining all non-tobacco nicotine 'medicine' that will remove the protective provisions of the commercial market and the product, in the form many people prefer, will be driven to the unregulated underground market. That will make it very risky and consumers will be far more vulnerable to abuse and accident.

  2. electronic cigarettes are replacement for hazardous traditional cigarettes! I really think that the FDA should do more research on this amazing products since it has proven on being very effective product for those who are seeking for a better alternative to smoking.Rather than having 4000 plus dangerous chemical conventional cigarettes putting millions of lives into jeopardy!

  3. EXCELLENTTTT article! First article I've read that makes this very valid point.

    However Judge Leon actually ruled against the FDA, telling them that they do not have any control over it because it's not a tobacco product. Last I heard they were appealing, will be interesting to see how it all turns out in the end.

  4. The fda said fruit flavor and mint is for kids? I'm 672 yrs. old and I love those flavors will they make me feel younger? My statement makes as much sense as theirs. Plus their statement about propylene Glycol in antifreeze. Should I sue the makers of the flavorings my family uses in their baking? Why can't the FDA tell the whole story in their reports instead of picking out bits of facts that promote their cause and omitting facts from those same tests and studies? Must they resort to biased reports just to fool the public into submission?