Monday, October 10, 2016

FDA Poised to Issue Rule that Will Be Devastating for Public Health, and Possibly Unconstitutional

It appears that the Food and Drug Administration (FDA) is preparing to issue a rule that would prohibit e-cigarette companies from suggesting that their products may be useful for smoking cessation. The proposed rule, as reported by The Hill, would classify as a drug/device any e-cigarette or vaping product that makes any claims related to quitting smoking.

According to the article: "The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products. The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use. The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday. The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease. ... “Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking,” the rulemaking said."

The Rest of the Story

This rule would be disastrous for the protection of the public's health because it would mean that vaping companies could not inform consumers that the primary purpose of e-cigarettes is to help smokers get off of cigarettes (i.e., quit smoking). They could not share testimonials about smokers who have quit using e-cigarettes because doing so would likely be interpreted by the FDA as making a cessation claim, which would subject the product to the regulations related to drugs, which would require clinical trials before the product could be marketed.

This rule will essentially force e-cigarette companies to market their products as cool, digital devices - a message that resonates with youth and will increase the appeal of these products to youth. The alternative - that the FDA allow cessation claims - would enable companies to tell the truth to consumers and to market these products based on their actual intended use. In other words, this rule would essentially force e-cigarette companies to lie to consumers and to withhold from them critical information.

Here is why I do not believe that this rule will pass legal muster, if challenged:

The FDA is making a false assumption. They are assuming that smoking is a disease. The agency is apparently going to state, correctly I would add, that an e-cigarette that is primarily intended to prevent or treat a disease is a drug/device. However, the agency goes one step further and rules that products which make claims related to smoking cessation are therefore intended to treat a disease. This of course assumes that smoking is a disease.

I disagree. I don't believe that smoking is a disease. Rather, it is a health behavior. Sure, it is a health behavior that is related to a number of diseases, but smoking itself is not a disease, per se.

Simply stated, a smoking cessation claim - in isolation - is not necessarily a drug claim - because the intention is not to treat a disease, but to help consumers change a health behavior. Since changing a health behavior is not treating a disease, the FDA has no legal authority to regulate e-cigarettes which make smoking cessation claims as drugs or drug/device combinations.

OK, so you may ask: If a smoking cessation claim is itself not a therapeutic claim, then why is the FDA able to regulate nicotine replacement therapy and varenicline as drugs? The reason is that these products are designed and intended to treat a disease: nicotine dependence. The DSM recognizes nicotine dependence as a disease and nicotine withdrawal is a health symptom. Since these products are primarily intended to treat nicotine dependence and to prevent withdrawal symptoms, they are rightfully considered to be drugs.

Of course, if e-cigarettes are marketing with a claim that the product is intended to treat nicotine dependence or to prevent withdrawal symptoms, then it's a different story. But by itself, a claim that vaping can help people quit smoking, or even that it is intended to help people quit smoking, is not a therapeutic claim, and the FDA must allow such claims to be made.

Hopefully, this rule will be challenged in court.

Here is a more detailed treatment of this issue:

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 the FDA's reasoning, then the apple orchard would have to stop making this claim. One can easily see, I believe, that the FDA'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 the FDA'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 the FDA's 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.

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 the FDA 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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