I reported last week that Senator Frank Lautenberg (D-NJ) has announced that he wants the FDA to immediately take electronic cigarettes -- which deliver essentially pure nicotine (with no tar or other tobacco constituents) -- off the market. I argued that although there are potentially serious health effects of nicotine, especially with regards to heart disease, there are no other toxic chemicals and no carcinogens, so there is no risk of cancer or chronic obstructive lung disease. Thus, the introduction of electronic cigarettes into the U.S. market is a potentially life-saving intervention. There is initial evidence that many smokers have found the e-cigarette to be an effective method for smoking cessation. Moreover, it makes sense that smokers would find it more attractive to use an e-cigarette than a nicotine patch. It is quite plausible that many smokers would find the e-cigarette to be an alternative to smoking and it may actually be more successful in keeping them off cigarettes. If true, this would save countless lives, because many smokers would be greatly reducing their health risks by switching to a much safer alternative type of cigarette.
I also pointed out the hypocrisy of Senator Lautenberg and the health groups who supported him in his demand that the FDA pull these products off the market, as these very same groups are supporting legislation that would require the FDA to approve the existing high-risk cigarettes for sale in the U.S.
Here, I argue that the FDA should not exert jurisdiction over electronic cigarettes (which would mean the immediate removal of these products from the market), but instead should simply ask the companies to refrain from making drug claims. These products should be treated as cigarettes, not drugs, and therefore the Federal Trade Commission (FTC) should review the accuracy of the advertising claims. But by no means should the FDA pull the product off the market.
The Rest of the Story
Unfortunately, it is true that at least some of the electronic cigarette companies are making drug claims, which could be construed as placing these products under the definition of a "drug" as defined in the Federal Food, Drug, and Cosmetics Act at chapter 321, section (g)(1). Drugs are defined as products which are "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." Since at least some electronic cigarette companies are promoting their products as providing a "healthier smoking experience" or being the "healthiest alternative smoking product," these can be interpreted as being drug claims under 321(g)(1).
Does this mean that electronic cigarettes must be regulated as drugs under the Federal Food, Drug, and Cosmetics Act and taken off the market?
I believe the answer is no because the federal government could decide that the primary intention of these products is to serve as an alternative type of cigarette and that these products are actually cigarettes and not drugs. The FDA could make a judgment that electronic cigarettes are actually not drugs, but are cigarettes that are inappropriately making a drug claim. The FDA could, instead of asserting jurisdiction and taking the products off the market, ask the companies to refrain from making drug claims and allow the products to remain on the market under such circumstances.
Given the potential public health benefits of electronic cigarettes and the fact that these products do appear to be primarily portrayed as an alternative type of cigarette, I believe this would be the best course of action.
Once classified by the federal government as a type of cigarette that has inappropriately made a health claim and asked to refrain from making such a health claim, the FTC could review the advertising for these products to ensure that any claims made are supported.
Electronic cigarette companies can make factual statements about the nature and components of the product without crossing over into the territory of making a drug claim. For example, these companies can state that the product is free of tobacco, that there is no smoke produced, and that it does not expose users to the carcinogens and other chemicals (other than nicotine) in cigarette smoke. These are ingredient and characteristics statements and not drug claims. The companies merely need to refrain from claiming that the product is healthier than traditional cigarettes.
Of course, electronic cigarettes are almost certainly safer than traditional cigarettes, but by making the claim, the producers are making a drug claim that could allow the FDA to exert jurisdiction over the product.
Let's hope that the FDA takes the action that is most reasonable and most considerate of the best interests of the public's health and that it simply ask the electronic cigarette companies to refrain from making drug claims, rather than taking the product off the market.