In these letters, the FDA asserts jurisdiction over electronic cigarettes under FDCA on two grounds:
First, that electronic cigarettes are "capable of delivering nicotine."
Second, that the products in question are marketed "as smoking deterrents or to reduce dependence on traditional tobacco products."
In asserting that some of the companies are making smoking deterrent claims, the FDA relies in part upon testimonials by consumers placed on the companies' web sites. For example, in asserting that Johnson Creek Enterprises is making smoking cessation claims, the FDA cites a web site testimonial from a customer who states: "I have been off tobacco cigarettes for a week" and from another who states: "If I had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again with as good as I feel right now."
In asserting that Ruyan is making smoking cessation claims, the FDA cites a web site testimonial from a customer stating: "My grandmother smoked like a chimney. After I bought her the Ruyan products, she reduced her cigarette smoking remarkably."
Furthermore, the FDA relies upon 21 CFR 310.544 to argue that any claim that a product helps reduce smoking makes the product a smoking deterrent drug product. That section reads: "Any product that bears labeling which claims that it helps stop or reduce the cigarette urge, helps break the cigarette habit, helps stop or reduce smoking, or similar claims is a smoking deterrent drug product."
The Rest of the Story
In this commentary, I argue that a major basis for the grounds used by the FDA to assert jurisdiction over electronic cigarettes under FDCA is flawed and does not hold up when viewed in light of the overall regulatory scheme that has now been established for tobacco products under the Family Smoking Prevention and Tobacco Control Act's amendments to FDCA (which I will refer to as the Tobacco Act). Furthermore, I argue that the FDA's invocation of 21 CFR 310.544 is being inconsistently applied and could lead to absurd consequences if applied in this way.
First, a major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. A tobacco product is: "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
Thus, a major ground for the FDA's assumption of jurisdiction over electronic cigarettes in these warning letters is legally flawed and inappropriate. And I believe this aspect of the FDA's argument for jurisdiction over NJOY cigarettes under FDCA will be rejected by the D.C. Court of Appeals.
Now to the second major ground for the FDA's assumption of jurisdiction over these electronic cigarette brands: that they make claims (often through customer testimonials) that they can reduce the amount of cigarettes smoked and therefore are smoking deterrents under 21 CFR 310.544.
While I agree that an electronic cigarette company which makes direct marketing claims that the primary intended use of its product is to achieve smoking cessation is making drug claims for which the FDA could assert jurisdiction under FDCA, I do not believe that 21 CFR 310.544 is the appropriate grounds for such a claim of jurisdiction. Also, I do not believe that the basis for the conclusion that two of the companies - Johnson Creek Enterprises and Ruyan - are making drug claims is appropriate because it relies upon customer testimonials rather than direct marketing claims made by the manufacturer or distributor. Moreover, I do not believe the FDA is consistently applying the reasoning it is using in asserting jurisdiction over electronic cigarettes under this legal ground and that application of this reasoning could lead to absurd (or at least unintended) regulatory consequences.
My argument here is a bit more complex than my refutation of the FDA's claim of jurisdiction over electronic cigarettes under the grounds that they deliver pharmacologically active nicotine, so I will approach this by providing some examples to illustrate my points.
Under the FDA's reasoning, a company can be said to be making drug claims about its tobacco product if that company puts testimonials on its web site indicating that a consumer of the product has quit smoking or reduced the amount of cigarettes consumed as a result of using that alternative tobacco product. Well, if that's the case, then Camel Snus could just as easily be said to be making drug claims. Why? Because on the Camel Snus web site, a customer testimonial boasts about how the use of Camel Snus helped her to sustain her attempt to stay off cigarettes and is helping her to breathe better and have less symptoms of smoking withdrawal:
"I'm a girl... I quit smoking and was having a bad day of it and my son ran out to the store and came home with Camel Snus Frost... Told me not to give up, Wow! Thank God I know no tobacco is "good" for me but at least I can breath[e] and not want to kill everyone."This individual is clearly boasting on the R.J. Reynolds Camel Snus web site of the effectiveness and usefulness of the product in helping her to sustain a cigarette quit attempt. The individual is also boasting about how the product is helping to improve her health: she can breathe better. Furthermore, the individual boasts how the product is helping to reduce the symptoms of cigarette/nicotine withdrawal: she no longer wants to kill everyone.
Why is the FDA not writing a warning letter to R.J. Reynolds stating that Camel Snus is being marketed (based on this customer testimonial) as a smoking deterrent or smoking cessation aid and that under 21 CFR 310.544 it is therefore a smoking deterrent drug over which the FDA is going to assert jurisdiction under FDCA?
I'm not arguing that the FDA should do this; I'm merely pointing out that the precise reasoning being used by the FDA to assert jurisdiction over Johnson Creek and Ruyan electronic cigarettes under FDCA could just as easily be used to assert jurisdiction over R.J. Reynolds' Camel Snus under FDCA.
Here is another example: Where are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit? These products are clearly being marketed as smoking cessation aids. The title of the web page is: "Quit Smoking Cigarettes." The company claims: "Mint Snuff Pouches are the perfect alternative to cigarettes and smokeless tobacco and they freshen your breath, too! The next time you reach for a cigarette, Pop a Pouch instead." A similar product - Mint Snuff Chew - is being marketed as helping smokeless tobacco users to quit: "Mint Snuff Chew is a non-tobacco chew made of mint instead of tobacco which has helped thousands of tobacco users quit tobacco."
What I'd like to know is where is the FDA's evidence that Mint Snuff Chew is effective for quitting smokeless tobacco? Where, FDA, are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit?
The company is making direct claims that the primary purpose of the product is to help users quit smoking cigarettes or quit chewing tobacco. Clearly, then, the product is intended for use in treating nicotine dependence and it therefore is intended to cure, mitigate, treat, or prevent disease, under the precise arguments made by the FDA in its warning letters to the electronic cigarette companies.
Yet, where is the FDA's warning letter to this company, demanding that the company carry out clinical trials to establish the effectiveness of the product in helping smokers quit?
Once again, I'm not arguing here that the Oregon Mint Snuff Company should be required to conduct clinical trials demonstrating that its mint snuff pouches are effective in helping smokers quit. But I am demonstrating that the FDA is being quite inconsistent in applying 21 CFR 310.544 and in invoking smoking cessation claims to assert jurisdiction over products.
If anything, I would argue that the Oregon Mint Snuff Company's claims are definitively drug claims under FDCA and they are stronger claims than those being made by at least two of the electronic cigarette companies which received warning letters. The mint snuff company's marketing claims make it very clear that the primary and only intended use of the product is to help quit smoking or quit using smokeless tobacco. In contrast, the electronic cigarettes are being marketed primarily as smoking alternatives with a secondary mention of reduction or elimination of smoking. Regardless, any kind of consistent application of 21 CFR 310.544 would have the FDA demanding clinical trials from the Oregon Mint Snuff Company demonstrating that its products are effective in both smoking cessation and smokeless tobacco cessation.
Yet another example is Bacc-Off, which is clearly being marketed with the direct and primary purpose of quitting smokeless tobacco use. In fact, the company claims that: "If you are trying to quit the use of smokeless tobacco, but need something as a substitute, Bacc-Off is the perfect solution."
So where is the warning letter to the manufacturer of Bacc-Off, demanding to see the clinical trials which demonstrate that smokeless tobacco users who try the product are significantly more likely to quit than those who try a placebo? Where are those clinical trials?
I'm also interested in seeing the clinical trials demonstrating that Ciga-Mint helps smokers quit. The company is making unequivocal drug claims: smoking cessation claims. Yet I don't see any FDA warning letter to the Ciga-Mint company demanding to see the clinical trials of this product's effectiveness in smoking cessation.
Similarly, where are the warning letters demanding to see the clinical trial data showing that the following products, each of which is clearly making drug claims under 21 CFR 310.544, are effective in helping smokers quit:
Altoids ("Great tool for quitting smoking")
Stress Mints (They "reduce" the "craving" to smoke)
DX Mint Cigarettes ("helps you effortlessly quit smoking")
E-Z Quit Artificial Cigarettes ("When you inhale through an E-Z QUIT, the cartridge releases a flavor that refreshes your mouth and occupies your taste buds. Through psychological mechanisms it "fools you" into thinking you are smoking the real thing, and as a result it helps you to quit smoking. You just inhale through this device whenever you get the next urge to smoke, and it helps carry you over each crisis.")
Ice Breakers Mints and Gum ("For the individual trying to quit smoking, Ice Breakers Mints and Gum provide an alternative, especially during those difficult first weeks. Pop an Ice Breaker into your mouth to deal with that cigarette desire.")
I'm not aware of any clinical trials demonstrating that these cigarette alternatives, which are being marketed as smoking deterrent drugs, are effective for smoking cessation. Yet the FDA is not taking action against these companies to ensure that the products are not marketed until they are proven to be effective for smoking cessation.
Taken to its extreme, the FDA's invocation of 21 CFR 310.544 and its determination of intended use based on customer testimonials could lead to absurd consequences, where if a customer writes on a web site that he found a breath mint helping in reducing smoking the company could be cited as being in violation of the Food, Drug, and Cosmetic Act.
The rest of the story is that the FDA's assertion of jurisdiction over electronic cigarettes is problematic for two reasons. First, the fact that these products deliver nicotine is being used improperly as a grounds for regulating the product under FDCA. Second, the secondary use of electronic cigarettes as a smoking cessation tool is being construed improperly from customer testimonials and the invocation of 21 CFR 310.544 is being inconsistently applied.
Of course, the greatest problem with the FDA's treatment of electronic cigarettes is the absurdity of its efforts to take these products off the market while approving the sale and marketing of the far more dangerous real cigarettes. That will be the subject of tomorrow's post.