Glantz wrote: "The fact that the e-cigarette companies and their trade association have been encouraging their consumers to submit public comments to a docket about smoking cessation products can be read no other way than the e-cigarette companies and their trade association are promoting their products as having therapeutic benefit." He goes on to opine that such "therapeutic" claims render e-cigarettes subject to the FDCA, which would of course require them to either be removed from the market or to stop making these claims.
While Glantz' opinion seems, at first glance, to be a reasonable one, closer inspection reveals that it is not sound because a claim that electronic cigarettes can help a smoker to reduce or eliminate cigarette use by substituting for cigarettes is not a therapeutic claim.
The Rest of the Story
What is a therapeutic claim? Under the Food, Drug, and Cosmetic Act, it is defined as: "Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g)."
The key point is that in order to be making a therapeutic claim, one either has to claim that the product will treat or prevent a disease or claim that the product will affect the structure or a function of the body.
A. Is Smoking a Disease?
Is claiming that electronic cigarettes can aid in smoking cessation a claim that these products can treat or prevent a disease? That depends on whether smoking is a disease.
Smoking itself is not a disease, but a behavior. Just as eating unhealthy food is not a disease, but a behavior. Or as not exercising is not a disease, but a behavior. Or as drinking alcohol is not a disease, but a behavior.
In and of itself, a claim that electronic cigarettes can aid in smoking cessation is therefore not a therapeutic claim.
As long as electronic cigarettes are marketed as an alternative to cigarettes which may help the user cut down or eliminate cigarette use, then it is simply claiming that it may affect a health behavior, rather than that it will treat or prevent a disease.
Consider the following scenarios:
1. An apple orchard decides to promote consumption of its apples by putting out advertisements which claim that buying apples from this orchard will help consumers to improve their diet and reduce their consumption of junk food. Does the FDA have jurisdiction over such claims under FDCA?
Of course not. The apple orchard is not claiming that is products (apples) will prevent or treat any disease. It is merely arguing that eating its apples is a healthy behavior. What is being claimed is that these products will improve health behavior, not that these products will treat or prevent a disease?
If the orchard claimed that eating its apples would reduce the risk of heart disease, then that could be interpreted as a therapeutic claim because it is claiming that its product will prevent a disease. But a simple claim that eating these products will improve one's diet is a behavioral claim, not a therapeutic one.
If we applied Stan's reasoning, then the apple orchard would have to stop making this claim. One can easily see, I believe, that Stan's argument does not hold.
2. I decide to sell a calendar that includes inspirational pictures of people exercising. It also contains reminders on certain days of the week to remind people to exercise on those days. I send out a flyer, advertising my calendar, in which I claim that this calendar may help people to exercise more often. Is that a therapeutic claim?
Of course not. Lack of exercise is not a disease. It is a behavior. I am not claiming that my calendar will treat or prevent any disease. I am only claiming that my calendar could influence one's health behavior. But again, by Stan's argument, this is a therapeutic claim and renders my calendars subject to the FDCA.
3. I conduct an educational program about alcohol, inviting people to come learn about the potential harms of alcohol use. At the program, I offer for sale a booklet that I claim can help people reduce their alcohol use. Do I need FDA approval to sell my booklet?
Of course not. It is only claiming to help people alter their behavior. It is not making a therapeutic claim. But again, by Glantz' reasoning, since it is claiming to affect a health behavior, it is indeed a therapeutic claim and would not be allowed.
I have demonstrated that in and of itself, claiming that electronic cigarettes may be useful in smoking cessation is not a therapeutic claim. Of course, the companies must refrain from claiming that the use of electronic cigarettes will reduce the risk of disease (that would be a therapeutic claim). But as long as they restrict their marketing to claims that these products may influence smoking behavior, then the claim is not a "therapeutic claim."
B. Is a Smoking Cessation Claim One that the Product Will Affect the Structure or Function of the Body?
It depends. Specifically, it depends on the mechanism by which the company is claiming smoking cessation will be achieved. If the mechanism involves any alteration of the structure or function of the body, then the claim could be interpreted as a therapeutic one. However, if the company is not claiming that the structure or function of the body will be affected, then it is not a therapeutic claim.
Suppose that an electronic cigarette company markets its products by boasting that they are intended to deliver nicotine with the goal of relieving symptoms of nicotine withdrawal and therefore making it possible for the smoker to quit smoking. If the primary intended purpose of the device is to deliver nicotine in order to prevent withdrawal symptoms by occupying nicotine receptors, then this type of marketing claim could be interpreted as a therapeutic claim.
This is, in fact, the reason why NRT products are regulated under FDCA. These products are specifically designed and intended to affect the structure and function of the body. They are designed to bind to nicotine receptors and prevent nicotine withdrawal, thus aiding the smoking cessation process. Similarly, Chantix is designed as a nicotine agonist. It works by altering the structure and function of the body.
However, suppose that an electronic cigarette company markets its products not by intending that the product's purpose is to prevent nicotine withdrawal symptoms during quit attempts, but instead, by simply intending that the product's purpose is to serve as an alternative to cigarette smoking. Suppose that the marketing of the product is focused on providing an alternative to cigarette smoking that does not involve tobacco or combustion. Then it is not making a therapeutic claim because it is not claiming that this product is intended to affect the structure or function of the body.
Summary of My Argument
There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM-IV.
I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.
Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.
In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.
In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.
As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.
The rest of the story is that the world is not as simple as Stan would like us to believe. A smoking cessation claim, in and of itself, is not necessarily a therapeutic claim. The situation is a lot more nuanced than that.
In my opinion, electronic cigarette companies should be allowed to truthfully inform consumers that their products may be useful for smoking cessation, as long as these claims are made within the general framework of marketing electronic cigarettes as an alternative to tobacco cigarettes. Such claims are not therapeutic claims as defined by section 201g of the FDCA.
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