Previously, I have argued that electronic cigarettes cannot be regulated by the FDA under the Food, Drug, and Cosmetic Act (FDCA) simply because they deliver nicotine, which is a pharmacologically active drug. I noted that electronic cigarettes, like regular cigarettes, smokeless tobacco, and nicotine replacement (NRT) products, meet the initial definition of "tobacco product" under the Tobacco Act because a constituent of the product - nicotine - is derived from tobacco.
What separates nicotine replacement products out from cigarettes and smokeless tobacco, I argued, is the fact that NRT products are marketed specifically for a therapeutic purpose - treating nicotine dependence. Since cigarettes and smokeless tobacco are marketed simply for recreational purposes, they cannot fall under FDA jurisdiction under FDCA. In contrast, NRT products are marketed for the specific purpose of treating a medical condition - nicotine dependence - and therefore can be regulated by the FDA under FDCA.
If the FDA is correct in asserting that electronic cigarettes are subject to FDCA solely because they deliver nicotine which is pharmacologically active and intended to affect the structure and function of the body, then the FDA must also regulate cigarettes and smokeless tobacco under FDCA, I argued, because those products also deliver nicotine that is intended to affect the structure and function of the body.
In today's commentary, I argue that there is an additional reason why the FDA's argument for regulation of all electronic cigarettes does not hold water: the FDA's argument asks that we look solely at the nature of the product, absent any marketing claims. The FDA appellate brief in the NJOY case demonstrates that the Agency is admitting that NJOY is not marketing its electronic cigarettes for any therapeutic purpose. The company makes no claim that NJOY is intended to, or will help its customers quit smoking. Nevertheless, the FDA has asserted jurisdiction over the product. That, I argue here, runs counter to logic as well as to legal precedent established by the Supreme Court itself.
The Rest of the Story
To understand why the primary, intended use of a product -- established through its marketing -- is the central element in evaluating the definition of a drug or device, consider the following example:
Why is the FDA not regulating potatoes as a drug?
Potatoes, it can be shown, contain nicotine, which is a pharmacologically active substance. Why, then, are potatoes not subject to regulation as drugs under FDCA?
The answer is simple: because they are being marketed as foods, not as drugs.
Now consider this variation:
I have just applied for a patent on a new product I developed. It's called Nic-A-Spud. By combining Idaho and Maine potatoes in the correct proportion (sorry, I can't reveal what that is), I have developed a product that I believe can relieve the symptoms of nicotine withdrawal. I plan to begin marketing it tomorrow as a useful strategy for smokers who are trying to quit. By taking my special Nic-A-Spud remedy, which consists solely of Maine and Idaho potatoes in a certain proportion that only I know, I believe that the user ingests a very small amount of nicotine which is able to quell any symptoms of nicotine dependence and thus help her to quit smoking with greater success.
Now, the question: is my Nic-A-Spud product - which is ingested like a food and consists of nothing other than potatoes - subject to regulation as a drug?
The answer is: yes. I am clearly making drug claims about the product. I am marketing it with the primary intended use of treating nicotine dependence and helping smokers to quit. I am claiming that by ingesting Nic-A-Spud, you will be exposed to nicotine which will have the pharmacologic effect of binding to nicotine receptors and altering the structure and function of the body.
Already, I hope that you can see why it is that the primary intended use of a product is instrumental in determining how a product can or cannot be regulated by the FDA.
Potatoes cannot be regulated by the FDA simply because they contain nicotine, which is a pharmacologically active drug. However, if those very same potatoes are marketed with the primary intent of treating a medical condition - nicotine dependence - then the product all of the sudden becomes a drug that can be regulated under FDCA.
If potatoes deliver pharmacologically active nicotine but are not regulated by the FDA as a drug, then why can electronic cigarettes be regulated by the FDA as a drug?
Clearly, the answer has something to do with the way in which the product is marketed, not solely what is in the product.
Now, let's examine another scenario. Suppose that Philip Morris decides to market Marlboros as a way to treat schizophrenia. There is evidence that nicotine helps reduce the symptoms of psychotic disorders. Obviously, if Philip Morris wanted to market Marlboros as a treatment for schizophrenia, it would have to prove that the product is safe and effective. The product would clearly be regulated under FDCA.
So the fact that a product is a tobacco product and supposedly not subject to regulation under FDCA does not actually mean that it is not subject to regulation under FDCA. It simply means that the fact that the product contains and delivers a pharmacologically active drug - nicotine - cannot be used as a basis for the FDA asserting jurisdiction over the product under FDCA. But if the product makes specific, primary drug claims, then all bets are off.
In other words, what I'm trying to demonstrate is that the issue of whether the FDA can assert jurisdiction over electronic cigarettes is dependent upon the way in which these products are marketed. You cannot simply look at the ingredients and assert such jurisdiction. You must look at the marketing claims and determine whether the primary intended use of the product is to treat a medical condition.
Now here's where I am going to extend my argument a bit. 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.
Now let's move to the final facet of my argument: why do I say the "primary" intended use of a product is what is important?
Take this example: suppose that a cigarette company posts on its website articles about how cigarette smoking has been found to reduce the risk of inflammatory bowel disease. Suppose that some customers make comments on a tobacco company web site indicating that they are using the product, in part, because they believe it will reduce their risk of inflammatory bowel disease. Suppose the company even asserts, on its web site, that cigarette smoking reduces the risk of inflammatory bowel disease.
Does this mean that the company's cigarettes are drugs and can be regulated under FDCA?
I think the answer is clearly "no." The company is making a secondary claim about cigarettes, not a primary claim. The primary intended use of the cigarettes is a recreational one. They are not being marketed for the primary intended purpose of preventing inflammatory bowel disease. Does this mean that the manufacturer cannot note that the product may reduce the risk of inflammatory bowel disease? I don't believe so, and it certainly does not give the FDA authority to regulate the product as a drug.
Clearly, the FTC could intervene (and the FDA could now intervene on marketing grounds) if it felt that the claim was deceptive marketing. But the fact that the company made such a claim would not put the cigarette into the category of a drug that could be regulated under FDCA unless the company was making a primary claim that the product was intended to prevent inflammatory bowel disease.
What does this mean? It means that unless an electronic cigarette company is making a claim that the primary purpose of its products is to treat nicotine dependence or nicotine withdrawal, then I do not believe the product is a drug subject to regulation under FDCA. Just because an electronic cigarette company posts a customer comment noting that some individual was able to quit smoking, that does not mean that the product is subject to jurisdiction under FDCA. Even if the company were to cite data showing that a significant number of consumers reported that the product helped them quit smoking, that would not make the product a drug, unless the primary aim of the product was to treat nicotine withdrawal. If marketed primarily as an alternative to smoking, I do not believe that electronic cigarettes are a drug.
The final point I would like to make is that there is strong precedent, in Supreme Court rulings, lower court rulings, and FDA rulings, which establishes that FDA must consider the intended use of a product in making a determination whether that product is a drug under FDCA. Perhaps most relevant is the Supreme Court's ruling that tobacco products cannot be regulated as drugs under FDCA absent a therapeutic or drug claim by the manufacturer.
As the Supreme Court noted in FDA v. Brown & Williamson Tobacco Corp.: "In 1977, ASH filed a citizen petition requesting that the FDA regulate cigarettes, citing many of the same grounds that motivated the FDA's rulemaking here. ... ASH asserted that nicotine was highly addictive and had strong physiological effects on the body'; that those effects were 'intended' because consumers use tobacco products precisely to obtain those effects; and that tobacco causes thousands of premature deaths annually. In denying ASH's petition, FDA Commissioner Kennedy stated that 'the interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors.' ... After the matter proceeded to litigation, the FDA argued in its brief to the Court of Appeals that 'cigarettes are not comprehended within the statutory definition of the term drug absent objective evidence that vendors represent or intend that their products be used as a drug.'"