New FDA Rule is Wrong on the Law: Smoking Cessation Claims are Not Inherently Therapeutic Claims Because Smoking is Not a Disease

On Monday, the FDA will issue a new rule whose intent is to clarify the conditions under which electronic cigarettes will be regulated as drugs instead of as tobacco products. Essentially, this amounts to a rule regarding what claims electronic cigarette companies are allowed to make (since few, if any, of these companies can afford the expenses associated with preparing a new drug application).

As the FDA explains, by statute there are two claims that would make an electronic cigarette subject to regulation as a drug under the Food, Drug, and Cosmetic Act:

1) If the manufacturer makes a therapeutic claim

This means a claim that the product is intended to prevent or treat a "disease."

2) If the manufacturer makes a structure/function claim

This means a claim that the product will affect the structure or function of the body in a way different than the way cigarettes have traditionally been marketed.

So far, so good.

Under the second prong (structure/function claims), the FDA correctly points out that if an electronic cigarette were to be marketed with the intended purpose of treating nicotine dependence, preventing nicotine withdrawal, or another purpose associated with the delivery of nicotine that is not typically used with cigarettes, it would be subject to regulation as a drug.

So far, so good.

The Rest of the Story

The problem comes under the FDA's interpretation of the first prong. The FDA argues that pretty much any smoking cessation claim is inherently a therapeutic claim. While the agency does not go as far as proclaiming that there is no exception to this rule, the agency makes it clear that at first blush, any smoking cessation claim will essentially be taken to imply a therapeutic claim.

The document reviews public comments, and the response to Comment 38 is most relevant. The FDA describes the comment as follows: "FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence." This appears to be my comment or at least to follow the lines of the argument that I've made several times on this blog.

In response, here is what the FDA says: "Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult  smokers want to quit smoking completely for health reasons. Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence maybe developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in §1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction."

The response is problematic because it doesn't actually address my argument. The basic argument is that smoking is not a disease, so in isolation, a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease. The intention is to help alter a health-related behavior.

Some examples may help illustrate this concept.

Suppose I design a calendar and on each page there is an inspirational quotation intended to inspire people to engage in physical activity. Clearly, the intended use of the calendar is to help change a behavior that has substantial health implications. But it also seems clear that the FDA would not regulate my calendar as a medical device because there is no therapeutic claim. Moreover, there is a second purpose to the calendar: to keep track of appointments. The intention of the calendar is clearly not merely related to helping someone to get more exercise. The quotes could be removed and the calendar might still be useful.

If marketed carefully, e-cigarettes are similar. The primary intended use is to help change a behavior, not to treat a disease. Moreover, the intention of the product is not merely to deliver nicotine but also to serve as a recreational alternative to smoking that simulates the smoking experience. In fact, many e-cigarettes are marketed with zero nicotine e-liquids. This raises a critical point: the nicotine could be removed and e-cigarettes would still be useful to many people. There are a fair number of vapers who indeed use zero nicotine e-liquids.

If e-cigarettes are marketed in widespread fashion with no nicotine and no claims regarding the treatment of any disease, then how can they possibly be considered to be a drug or device based solely on a smoking cessation claim?

Nicotine replacement products are drugs because they are specifically intended to treat a disease: nicotine dependence. They work by delivering nicotine to prevent nicotine withdrawal. In addition, there is no nicotine replacement product that doesn't contain nicotine. The idea of a zero-nicotine patch is ridiculous. Clearly, it is not putting the patch on that is being marketed. What is being marketed is the delivery of nicotine. The patch is just the delivery mechanism.

Things are very different with e-cigarettes. While nicotine is sometimes delivered, the primary feature of the product is that it substitutes for cigarettes. It is a recreational alternative that looks and feels somewhat similar. And the delivery of nicotine is not critical to the product's purpose. Otherwise, there would be no zero-nicotine e-cigarettes on the market.

As the FDA itself points out, the approved label for nicotine replacement therapies states: "Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." The reduction of withdrawal symptoms is critical to the product's function. In addition, it is intended to affect the structure/function of the body because it is designed to occupy nicotine receptors in order to prevent a physiological phenomenon of nicotine withdrawal.

I am not arguing that there are never situations in which a smoking cessation claim by an e-cigarette manufacturer should be treated as a therapeutic claim. But I am arguing that making a smoking cessation claim is not dispositive of demonstrating a therapeutic intent.