As Jacob Sullum reports at the Reason Online Hit & Run blog, it appears that the Food and Drug Administration (FDA) is poised to assert regulatory jurisdiction over electronic cigarettes. A message from the FDA's Office of Legislation, which was sent out last Wednesday, announces that the Agency will take an "enforcement action" against electronic cigarettes. Apparently, the FDA has already taken some actions to block the sale of electronic cigarettes, as the Blog of Legal Times reports that one electronic cigarette distributor has filed suit against the FDA for blocking imports of electronic cigarettes into the United States.
According to the Blog of Legal Times article, that lawsuit "argues that the FDA has overstepped its regulatory authority by banning shipments of the devices and insisting they need to go through the drug approval process. Electronic cigarettes — often marketed as “e-cigarettes” — are a tobacco-free version of traditional smokes. Users inhale vaporized nicotine from a small, plastic tube that heats up with the help of a tiny battery. The whole contraption is designed to look and feel like a normal cigarette, minus the flame and smoke, and their makers market them as a risk-free way to get a nicotine buzz. Smoking Everywhere’s lawyers from Thompson Hine point out that in 2000, the Supreme Court ruled that the FDA did not have the power to regulate ordinary cigarettes. Therefore, it shouldn’t be allowed to clamp down on their high tech counterparts, the lawyers argue."
The FDA message explains that its chief concerns about electronic cigarettes are that these products may introduce nonsmokers to nicotine use and that they have not been studied so we don't know if they are safe.
Sullum reports that [regular Rest of the Story commenter] Bill Godshall, executive director of Smokefree Pennsylvania, wrote to the FDA, arguing that: "denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users reverting back to smoking cigarettes. ... it is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products."
The Rest of the Story
There is no question that electronic cigarettes are designed and marketed primarily as being an alternative cigarette. Therefore, they should not be subject to jurisdiction by the FDA, which currently has no jurisdiction over cigarettes. Instead, they should be subject to regulation by the Federal Trade Commission, which should ensure that any advertising claims being made are accurate. In addition, efforts should be made to ensure that these products are not sold to minors. However, the last thing in the world that we want from a public health standpoint is for the FDA to regulate (which means ban) electronic cigarettes.
No evidence has been presented to suggest that either of the FDA's concerns are warranted. First, there is no evidence that electronic cigarettes are being used by minors, or by nonsmokers. They are clearly being marketed to smokers, and not to either minors or nonsmokers. A survey by one electronic cigarette company revealed that the average age of electronic cigarette users is 44 and that the average amount smoked by these individuals (prior to using e-cigarettes) is over 1 pack per day.
Second, there is no evidence that electronic cigarettes pose any undue harm relative to the smoking of conventional cigarettes that would warrant their being removed from the market. A laboratory study of the emissions from electronic cigarettes confirmed that the only significant emissions are nicotine and propylene glycol.
I applaud Bill Godshall for being a voice of reason on this issue. The effect of taking electronic cigarettes off the market would not be a reduction in the number of individuals becoming addicted to nicotine. Instead, the result would be an increase in the the number of individuals using conventional cigarettes. Such an action by the FDA would undoubtedly have the effect of harming the public's health by taking away a safer alternative for thousands of e-cig users and essentially forcing them to go back to smoking conventional cigarettes, which we know are far more hazardous.
There is no reason to believe that current electronic cigarette users would quit smoking entirely if e-cigs are pulled from the market. In fact, there is almost no chance of that occurring, since the use of these products has continued their exposure to nicotine. Instead, they will likely return to conventional cigarettes.
While the FDA appears to be acting from ideological concerns, it should remember that its charge is to protect the public's health, not to enforce a particular ideology.
If the FDA doesn't act in the most prudent way, hopefully the courts will recognize that e-cigarettes are exactly that - cigarettes, and thus rule that they should not be subject to FDA jurisdiction.
I would close by noting that this story demonstrates yet another reason why enactment of the FDA tobacco legislation would be a public health disaster. If that legislation is enacted, then electronic cigarettes will be placed under FDA jurisdiction and the product will most likely have to be pulled from the market under the stringent rules established in that legislation for reduced risk products (which make it virtually impossible to market a truly safer product such as e-cigarettes).
This is just another concrete example of how the FDA tobacco legislation would be devastating to the public's health.
We simply cannot afford to allow ideology to get in the way of public health protection.
Finally, it is clear that the real purpose and effect of the FDA tobacco legislation is to protect the conventional cigarette market from competition. And unfortunately, that competition - in the absence of FDA legislation - would come from truly reduced risk products, such as electronic cigarettes. This is precisely why Philip Morris was brilliant and insightful enough to sit down with the Campaign for Tobacco-Free Kids and forge a deal that would give the FDA very limited regulatory jurisdiction over tobacco products, and in a way that protects existing products at the expense of new, potentially reduced risk ones.
Today, the Campaign and its fellow health groups stand as the most vigorous protectors of the current market of conventional cigarettes that one could ever imagine. As such, they stand as protectors, rather than opponents, of the death and disease caused by the nation's most hazardous consumer product.
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