Monday, May 21, 2012

"Safe and Effective?" Not the Correct Standard for Electronic Cigarettes

A number of anti-smoking groups have called for the removal of electronic cigarettes from the market until such time as they have been shown to be "safe and effective." For example, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) issued a press release to promote a ban on the sale of electronic cigarettes in the United States. The press release highlighted a letter written from the organization to the FDA requesting that the Agency remove electronic cigarettes from the market.

The press release stated: "The Association for the Treatment of Tobacco Use and Dependence (ATTUD), the premier professional organization of tobacco treatment specialists, today announced its support of the FDA ban on so-called "electronic" or e-cigarettes. The letter ... stated that there is no scientific evidence that the e-cigarettes are safe and effective." As tobacco treatment professionals we are concerned that smokers desperate to quit will place their faith in unproven therapies," said John Hughes, MD, President-elect of ATTUD and professor of psychiatry at the University of Vermont College of Medicine."

The letter to the FDA stated: "The Association of Tobacco Use and Dependence (ATTUD) is a non-profit organization of providers dedicated to the promotion of and increased access to evidence-based tobacco treatment for the tobacco user. As such, we are writing to support the Food and Drug Administration (FDA) enforcement action against manufacturers of “electronic cigarettes”. These products should be removed from the market until and unless they are proven safe and effective."

As another example, the prestigious Mayo Clinic has strongly advised smoking patients against using electronic cigarettes to try to quit, stating: "If you're looking for help to stop smoking, there are many FDA-approved medications that have been shown to be safe and effective for this purpose."

Similarly, the American Legacy Foundation has published a policy statement which also calls for the removal of electronic cigarettes from the market until they have been shown to be "safe and effective." According to the statement, which is entitled "The FDA Should Take Electronic Cigarettes Off The Market Until It Is Satisfied That They Are Safe and Effective," the electronic cigarette must be taken off the market because it has not been shown to be either safe or effective: "While e-cigarettes are viewed by some as a less dangerous alternative to cigarettes or a potential smoking cessation aide, there had been no publicly available independent research on the critically important questions of safety and efficacy. With regard to safety, that has now changed with the FDA’s release on July 22, 2009 of extremely troubling laboratory findings regarding the constituents and manufacturing standards of some e-cigarettes now on the market. There continues to be no scientific support for the anecdotal claims that e-cigarettes are an effective smoking cessation aid."

More broadly, all of the major national anti-smoking groups, including the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, American Cancer Society, Action on Smoking and Health, American Academy of Pediatrics, and the American Legacy Foundation, have called for an immediate ban on electronic cigarettes because they claim we are not sure whether these products are safe and effective for use as smoking cessation devices.

The Rest of the Story

The problem with all of these calls for a ban on electronic cigarettes is that the "safe and effective" standard is no longer the appropriate standard that the FDA must use in regulating these products. The District of Columbia Court has ruled that electronic cigarettes are a "tobacco product" under the Tobacco Act and that in the absence of therapeutic claims by a particular manufacturer, they may be regulated under the Tobacco Act as tobacco products, but not under the Food, Drug, and Cosmetic Act as drugs, devices, or drug/device combinations. While the "safe and effective" standard is appropriate for FDA to use in evaluating applications for new drugs to enter the market, is is not appropriate for FDA to use in deciding whether electronic cigarettes - an alternative tobacco product - should be allowed to remain on the market.

In the absence of a specific therapeutic claim by a manufacturer, essentially the only standard that the FDA may use to decide whether an electronic cigarette is whether or not it is an "established product" by virtue of having been in interstate commerce in the U.S. as of February 15, 2007. I don't think there is any doubt that these products were being marketed in the U.S. in 2007, and thus, that they are established products that are grandfathered in by the Family Smoking Prevention and Tobacco Control Act.

The second question is whether new brands of electronic cigarettes, which may have been introduced subsequent to 2007, are "substantially equivalent" to the electronic cigarettes on the market in 2007. Hopefully, the FDA will interpret the term "substantially equivalent" quite liberally with respect to electronic cigarettes. Otherwise, it will create an absolute regulatory nightmare. Certainly, the spirit of the law supports such a liberal designation, since virtually all electronic cigarettes share basic risk profiles that put them in a completely separate ballpark from regular cigarettes.

Assuming that the FDA does apply the substantially equivalent standard liberally to electronic cigarettes, there will be no means by which to remove these products from the market. The interesting issue will then become: will these products be subject to the modified risk provisions of the Act, and if so, how stringently will those provisions be enforced with respect to electronic cigarettes.

Under the current guidance that the FDA has offered regarding the modified risk provisions, it would be virtually impossible for electronic cigarettes to be marketed as reduced risk products because the research evidence required would be monumental. The manufacturer would have to conduct a long-term clinical trial, demonstrate that the product reduces health risks in both the short-term and long-term, demonstrate that it does not induce smokers who would have quit to instead use e-cigarettes, and demonstrate that the benefits outweigh any costs related to new users who start vaping, in particular, youths.

This research burden is so strong that it is unlikely to be met in a setting where you don't have a few large e-cigarette companies. Instead, you have hundreds of small distributors. No single company has the money to conduct the research that would be necessary. It would take many years and in the mean time, companies could not tell their consumers that the product is any safer than regular cigarettes. That seems absurd to me.

Therefore, it is my hope that the FDA will not make electronic cigarettes subject to section 911's modified risk tobacco product provisions, or else, that the FDA will outline a separate procedure for electronic cigarettes to achieve modified risk status that is far less burdensome.

The rest of the story is that the "safe and effective" standard is not appropriate for electronic cigarettes, which have been deemed by the courts to be an alternative tobacco product, not a drug. The key question is not whether these devices are "safe and effective," but whether they are relatively safe and effective. In particular, are they relatively safe compared to tobacco cigarettes and are they relatively effective in keeping people off cigarettes compared to nicotine replacement therapy?

The answer to the first question is unequivocally yes. And the answer to the second is not yet clear. However, early signs, including abundant anecdotal and experimental evidence and the results of an initial clinical trial suggest that the answer may well be yes as well. Electronic cigarettes must continue to be available to smokers and ex-smokers while this research is conducted. The worst scenario would be to follow the anti-smoking groups' advice and remove these products from the market because they have not been proven to be "safe and effective."

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