The FDA has argued that it must seize shipments of electronic cigarettes and threaten to enforce a ban on these products because they have not been demonstrated to be effective for smoking cessation. Companies claiming that electronic cigarettes are helpful in smoking cessation have been served with warning letters instructing them to discontinue such claims or to produce the evidence for their effectiveness. According to the FDA, "all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes."
The Rest of the Story
This may be all well and good, but why is the same FDA which is threatening to ban electronic cigarettes because they have not been proven effective in promoting smoking cessation not also threatening to ban E-Z Quit Artificial Cigarettes, which are another smokeless product marketed with claims that they help users quit smoking? According to the E-Z Quit web site: "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."
Clearly, E-Z Quit is making the very same claim that the cited electronic cigarette companies are making: that the product will help users to quit smoking. However, I am not aware of any clinical trial evidence that E-Z Quit artificial cigarettes are effective for smoking cessation. So why should E-Z Quit be allowed to make such a claim but electronic cigarette companies not be allowed to make the claim? Especially when there is actually an abundance of anecdotal evidence that electronic cigarettes are effective, and there are several published studies which provide evidence that these products are capable of suppressing the urge to smoke. If anything, we have a lot more evidence that electronic cigarettes are effective than that E-Z Quit artificial cigarettes are effective. So why is the FDA threatening to ban the former, but not the latter?
E-Z Quit artificial cigarettes are just one example of a smokeless cigarette alternative that is being marketed for smoking cessation free of FDA interference. There are many others.
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. Where are the FDA's warning letters to the manufacturer of Mint Snuff Chew, demanding that the company carry out clinical trials to establish the effectiveness of the product in helping smokers quit?
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 claiming effectiveness in promoting smoking cessation, have been demonstrated to be 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")
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.
And where in the world is the FDA on Smokers' Cleanse? This product claims not only to help you quit smoking, but it makes the specific claim that it will improve "overall lung and respiratory health." If that's not a drug claim, then I don't know what is. Yet I'm aware of no clinical trials to show that Smokers' Cleanse is effective in helping people quit smoking. Nor am I aware of any FDA warning letters to the manufacturer of Smokers' Cleanse, insisting that it refrain from making smoking cessation claims in the absence of clinical trial evidence.
Don't get me wrong. I'm not arguing here that each of these smokefree cigarette alternatives or smoking cessation remedies should be taken off the market. I'm simply arguing that electronic cigarette companies should not be required to conduct clinical trials demonstrating that these devices are effective for smoking cessation while these other companies are allowed to make smoking cessation claims without such evidence. There needs to be some consistency in FDA policy towards smoking cessation products.