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The Fears - As reported in the Annals of Internal Medicine, Volume 153, Number 9, p. 607-609 (“E-Cigarettes: A Rapidly Growing Internet Phenomenon”):
We contend that the e-cigarette boom presents important public health concerns on at least 3 fronts. First, e-cigarettes may pose a risk as starter products for nonusers of tobacco. Although candy-flavored tobacco products and e-cigarettes were recently banned by the FDA in efforts to hinder marketing toward children, the posturing of e-cigarettes as “green” and “healthy” could deceptively lure adolescents. E-cigarettes also may represent a way for adolescents and adults to skirt smoke-free indoor air laws.
The Reality - As reported in Chapter 19 of the Tobacco Harm Reduction Yearbook 2010 (“Electronic cigarettes (e-cigarettes) as potential tobacco harm reduction products: Results of an online survey of e-cigarette users”):
All respondents previously smoked and 91% had attempted to stop smoking before trying ecigarettes. About half (55%) were 31-50, while 32% were >50 years old. Most (79%) of the respondents had been using e-cigarettes for <6 months and reported using them as a complete (79%) or partial (17%) replacement for, rather than in addition to (4%), cigarettes. The majority of respondents reported that their general health (91%), smoker’s cough (97%), ability to exercise (84%), and sense of smell (80%) and taste (73%) were better since using e-cigarettes and none reported that these were worse. Although people whose e-cigarette use completely replaced smoking were more likely to experience improvements in health and smoking caused symptoms, most people who substituted e-cigarettes for even some of their cigarettes experienced improvements.
Similar results were seen in two other surveys of users. J.F. Etter’s “Electronic cigarettes: a survey of users,” published in BMC Public Health reported, “Our results suggest that most people who buy these products are current and former smokers who use ecigarettes to help quit smoking, just as they would use NRT.” The median age was 37, ranging from 19 to 65 years. An unpublished survey conducted by the Consumer Advocates for Smoke-Free Alternatives Association (casaa.org) found that 50.9% of the 2,217 responders were between ages 30 and 49 years and 27.4% were older than 50 years, and 99.6% had been smokers.
Thus, reality certainly does not match the fears that e-cigarettes will be “starter products” geared towards adolescents and children. It is interesting that critics of e-cigarettes accuse manufacturers of offering flavors as a means of attracting children, but do not accuse the makers of Nicorette gum of luring children to their products via White Ice Mint, Cinnamon Surge, and Fruit Chill flavors.
Lastly, reality faces off against fear #3. E-cigarettes are not burned. Therefore they produce no smoke. Expressing fears that people will use them to “skirt smoke-free indoor air laws” is as ridiculous as fearing that children will purchase root beer as a means of defying laws against sales of alcohol to minors. Root beer isn’t an alcoholic beverage, and vapor isn’t air-polluting smoke.
Authors Yamin, Bitton, and Bates end their Annals of Internal Medicine essay with this statement: "Although the safety and efficacy of e-cigarettes is uncertain, we believe that clearly counseling patients against e-cigarette use, as well as other tobacco use, is prudent." Presumably, the authors would prefer that smokers stick with the FDA-approved smoking-cessation products that have a success rate that ranges from 2% to 7% when used as directed.
It is estimated that there are now a million former smokers who achieved their smoking abstinence by switching to e-cigarettes. It isn't at all prudent to recommend that they stop using e-cigarettes and risk relapse, nor is it prudent to steer current smokers away from a product that has a success rate that ranges from 63% to 80% based on the three surveys mentioned above.
It's simply a matter of how medical regulation works. If nicotine is medicine and ecigs are cessation products then of course they have to prove safe and effective before being allowed on the market. That is how the system works and it's to protect patients. If you believe that nicotine is a medical substance then you have to accept good practice for medicines.
ReplyDeleteOn the other hand, people who use recreational drugs are faced with increasing difficulty in being able to access them. Most substances are illegal or belong to a captured over-controlled regulatory system. There is little hope of keeping a free market in the US when users tout medical purposes or the need for over regulation by tobacco control.
The UK has an advantage in that there is an option to be regulated as a consumer product. Unfortuantely, the legal setup in the U.S. offers only two options at present: Be regulated as a drug under the Food, Drug & Cosmetics Act, or be regulated as a tobacco product under the Tobacco Act. If it chose to do so, the FDA could immediately promulgate reasonable regulations under the Tobacco Act to require vendors to list product ingredients, test for purity, and provide complete labeling information. But since the FDA continues to insist they are a drug and the court system disagrees, the products remain totally unregulated here.
ReplyDeleteI think you'll find that nicotine is available on the free market at the moment in the US. In order to ban ecigs they need to be brought into medical and/or tobacco control regulation. Default consumer regulations currently apply, same as in the UK.
ReplyDeleteWhatever, you're presenting a medical product, without doubt.
According to Judge Richard Leon of the United States District Court for the District of Columbia, "intended use" is the legal benchmark in the United States for determineing whether a product is a drug. Intended use is not determined by the consumers, but by the manufacturers and sellers. If the marketing message does not contain claims that the product will treat or mitigate a disease, the product is not a medical product. Judge Leon stated that the Tobacco Act includes products "derived from tobacco." Thus, e-cigarettes that contain nicotine produced from tobacco can be regulated by the FDA as tobacco products under the Tobacco Act.
ReplyDeleteWhich US consumer safety regulations do you believe would cover e-cigarettes?
BTW: The intended use of e-cigarettes is to function as a more-or-less permanent replacement for smoking by providing nicotine via less harmful method. In contrast, the intended use of the "smoking cessation" products approved by the FDA is to wean users off nicotine, thus treating the disease of nicotine addiciton. By using the term "smoking cessation" when what they really mean is "nicotine cessation", the FDA is confusing both vendors and consumers.
ReplyDeleteApparently not everyone (including the FDA, WHO and the EU) agrees that intended use is determined by the specific marketing of a particular company. Cessation claims, adverts and results of user surveys show that in the US intended use is indeed primarily for quitting. Expectations, popular opinion and common use are markers of primary purpose and intended use of a product. They're claimed to be nicotine replacement products, NRT is classed as a valid medical treatment, there is no argument against medicalisation and the need to satisfy regulatory demands. There is no need to prove they can wean anybody off nicotine to be medicine because nobody opposes long term NRT.
ReplyDeleteNicotine medical treatments reduce chances of smoke cessation: http://whyquit.com/pr/110210.html
http://www.unairneuf.org/2010/11/nhs-statistiques-angleterre-2010.html
This is the pharmaceutical scam. All recreational drugs are being systematically wiped out and handed to pharm companies with claims that they have no purpose other than medical purpose. If nobody presents a case against that or supports recreational use then there is nothing standing in the way of rent seeking legislation and a complete commodity grab.
Since nicotine is legal on the US consumer market, safeguard regulations such as truth in advertising apply as would presumably the right to hold sellers accountable in court for the product being fit for the purpose sold. Those regulations don't apply to a prohibited or black market. Until recreational nicotine use is brought into tobacco control or medical regulation it is legal as a traded commodity. Nicotine could be brought into tobacco control and removed to trace levels and/or it could be completely medicalised which will destroy ecigs as we know them. Those are the two most obvious routes to effective bans, I haven't heard of any others yet and guess that an outright ban might require a change in the constitution (which is what allowed alcohol prohibition). As I'm not an expert in US law I don't know but nobody has given me any reason to believe the free market can be shut down without further legislation or capture into existing regulatory structures. No regulators have accepted responsibility for ENFORCING consumer laws on nicotine within the free market and that's why it appears to be unregulated. The same thing happened in the UK, our commercial regulator tried to pass off responsibility to the medical regulator. Until that happens it is still the responsibility of the commercial regulator and they are now making sure that product on the market are advertised for recreational use and safe. Nicotine is a general sales product until it is captured in other regulation and that is the best place for it to be if you want the product to stay widely available and useful.
The only reason ecigs have been as successful as they have been is because they are on the free market. Tobacco control or pharm companies will put a stop to them when they get a chance because that's how they make their money.
I agree with most of what you say, with the exception of the legal definition in the U.S. of "intended use." Here is what Judge Leon had to say about the topic:
ReplyDelete[QUOTE]The "intended use" of a product is determined by "the objective intent of the persons legally responsible" for labeling the product. 21 C.F .R. § 201.128. Objective intent may be shown, for example, "by labeling claims, advertising matter, or oral or written statements" by the labeler. Id. It may also be shown "by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised." ld. Here, the overwhelming sum of Smoking Everywhere's promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use.[/QUOTE]
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
Defining what the product is for shouldn't be left to NJOY. It's not exactly helpful when they're the only ones arguing for recreational use and advocates are claiming they're liars. If they win their case then it will be against the efforts of all the major US campaigners I've heard from. Leon might be correct that intended use is defined solely by specific marketing but you're playing word games and batting for the baddies.
ReplyDeleteAll your arguments are in favour of giving nicotine to pharm companies and turning health authorities into drug dealers.
So that's it? No debate allowed. You're as transparent and as dangerous as the rest of the tobacco control industry.
ReplyDeletePerhaps I haven't been very clear about my position. I see electronic cigarettes as a REPLACEMENT for smoking, not as a treatment to wean people off nicotine. Thus there is no way I would call NJOY a liar about intended use, and I don't know of any e-cigarette advocate who would.
ReplyDeleteIt would be wonderful if we had an option 3, allowing e-cigarettes to be regulated by the Consumer Product Safety Commission. However those who understand the U.S. laws much better than I have stated that there are only two options for the product: Regulated as a drug to treat nicotine addiction, or be regulated as a tobacco product to be used recreationally.
The fact that people can and do use these products to suspend their use of tobacco cigarettes doesn't make them a drug. I might drink cranberry juice, on the advice of my doctor, to prevent or treat urinary tract infections. In the U.S., the fact that I use the product as a treatment, even if I shout it to the high heavens, does not make cranberry juice a drug. However, if Ocean Spray starts putting text on their labels that states cranberry juice treats UTIs, the FDA will be all over them to file an NDA. That's the way the law works in the U.S.
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