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You are Here: Home >> News >> Industry News >> FDA Will Issue Proposed Regulations For Electronic...
FDA Will Issue Proposed Regulations For Electronic Cigarettes In April

Jun 11st, 2013

According to a Troutman Sanders article, the Obama administration has announced that the FDA will issue proposed regulations for electronic cigarettes (as well as cigars, pipe tobacco, and other tobacco products) this April. While the Family Smoking Prevention and Tobacco Control Act created a regulatory framework for cigarettes and smokeless tobacco, it did not establish provisions for other types of tobacco products. The FDA intends to fill this gap by issuing regulations for these other products.
 
The Rest of the Story
 
There are several critical aspects of the regulation that I will be closely watching with regard to the regulation of electronic cigarettes. These provisions of the proposed regulations will have a major impact on whether or not electronic cigarette companies will be able to continue to make these products available to millions of smokers and ex-smokers who are using them and whether they will be able to tell the truth about the safety and intended use of the products.
 
Issue #1: Will the FDA Require a Substantial Equivalence Determination for Electronic Cigarettes?
 
This is a potentially dicey issue. If the FDA requires that electronic cigarettes introduced into the market after 2007 apply for a substantial equivalence determination, it could create massive havoc. After all, most of the electronic cigarette brands on the market were introduced after 2007. If the FDA simply adds electronic cigarettes under the existing regulatory framework, hundreds of electronic cigarette brands will be taken off the market and those companies will have to apply for a substantial equivalence determination before they can start selling them again. Given the fact that the FDA has been extremely slow with its current substantial equivalence applications and the fact that most electronic cigarette companies are small, this could essentially put an end to hundreds of electronic cigarette companies and brands.
 
Issue #2: Will the FDA Apply the Modified Risk Provisions to Electronic Cigarettes?
 
Doing so would be a public health disaster because it would mean that electronic cigarette companies could not tell the truth about their products to consumers. It would mean that these companies would have to hide the fact that electronic cigarettes are much safer than regular cigarettes. In other words, it would force these companies to hide important, truthful facts from the consumer. It would prevent the companies from being honest. Thus, applying the modified risk provisions to electronic cigarettes would be a mistake, as it would not serve the interests of the public's health.
 
Issue #3: Will the FDA Clarify What is Meant by a Therapeutic Claim for Electronic Cigarettes?
 
It is very clear that electronic cigarettes cannot market themselves as a drug or medical device that is intended to treat nicotine dependence. However, I do not believe it is clear that marketing electronic cigarettes for smoking cessation would represent making a therapeutic claim. After all, smoking is not a disease, but a behavior.
 
If I were to sell a special calendar that I contended would help increase the frequency with which people exercise, that would not be a therapeutic claim. I would not need FDA approval to sell my calendars. Yet the purpose of the calendars is to change a health behavior. It would not be considered a therapeutic claim because failing to exercise is not a disease. It is a behavior that puts one at risk of disease, but it is not a disease itself. In the same way, why should it be considered a therapeutic claim if I contend that my product can help smokers quit? What makes NRT or Chantix claims drug claims is that these products are intended to specifically treat nicotine dependence, which is recognized by the DSM-IV as a medical disease. The purpose of these products is to affect nicotine receptors and treat the problem of nicotine dependence. In contrast, electronic cigarettes are alternatives to smoking that are not primarily intended to treat nicotine dependence, but to provide a satisfactory alternative to smoking. I do not believe that electronic cigarette companies should be precluded from telling consumers that these products may be useful for smoking cessation.