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.
Here is a summary of my recommendations to the FDA for regulating electronic cigarettes:
1. In general, I would not put electronic cigarettes under the provisions of the Tobacco Act as it relates to cigarettes and smokeless tobacco. Instead, I would create a new, specific regulatory framework that applies uniquely and specifically to electronic cigarettes.
2. In accordance with #1, electronic cigarettes should not be subject to the substantial equivalence provisions, new product approval provisions, or modified risk product provisions for tobacco cigarettes.
3. All electronic cigarette companies should be required to do the following. Existing products would be granted a reasonable amount of time to furnish the required information. New products would have to submit the information prior to entering the market.
a. Register their company and products with the FDA.
b. Provide a list of the product ingredients, by brand.
c. Provide an analysis of the components of the electronic cigarette cartridges and vapor.
d. Demonstrate the absence of diethylene glycol in their cartridges (or presence at a level of below 0.1%).
e. Demonstrate that labeled nicotine levels correspond to the actual nicotine levels in the cartridges.
f. Demonstrate that levels of nicotine in cartridges labeled as "zero" are zero.
g. Demonstrate the safety of the battery.
h. Provide labeling that warns consumers against manipulating the battery/charger system.
i. Confirm procedures for not selling the product to minors.
4. Electronic cigarette companies would be permitted to truthfully inform consumers that these products are safer than tobacco cigarettes, are free of smoke, are free of tobacco, and do not involve combustion. They would be permitted to compare levels of constituents between electronic cigarettes and tobacco cigarettes. None of these truthful claims would require any sort of approval or designation as a reduced risk product.
5. Electronic cigarette companies would be permitted to inform consumers that these products have been found to be useful by many smokers in reducing cigarette consumption or quitting. These would not be considered therapeutic claims as long as companies do not state or imply that the products are intended to specifically treat nicotine addiction.
6. The FDA should create a priority research program that focuses on the following critical issues:
a. Battery safety
b. Diethylene glycol testing and an understanding of why diethylene glycol was present in some brands
c. Health effects of electronic cigarette use
d. Effectiveness of electronic cigarettes in reducing or eliminating smoking
e. Short and long-term effects of inhalation of propylene glycol
f. Mechanisms by which chemicals such as formaldehyde are created and methods to reduce or prevent its formation.
g. Differences in the chemicals produced in e-cigarette vapor using propylene glycol vs. glycerine as an excipient
h. Development of other excipients for nicotine vaporization that will minimize the presence of formaldehyde or any other volatile organic compounds.