Thursday, May 17, 2012

Further Analysis of FDA Warning on Electronic Cigarettes: What is the Agency Saying to Smokers Who Have Quit Using E-Cigs and Tried NRT Unscuccessfully in the Past?

One of the hallmarks of a national recommendation by a public health agency is that it applies to all persons unless qualified as to relate only to a sub-group of the population. Thus, the FDA's recommendations regarding the use of electronic cigarettes, which I highlighted yesterday, can be inferred as being meant to apply to the whole population, not only to smokers who have not yet tried electronic cigarettes.

Today, let's consider what the FDA is saying specifically to this sub-group of the population, which consists of thousands: ex-smokers who have quit successfully with the help of electronic cigarettes and who have tried NRT unsuccessfully in the past. In fact, the failure of NRT was the reason why most of these smokers decided to try electronic cigarettes in an attempt to quit smoking.

To remind readers, the FDA warns the public against the use of electronic cigarettes because their risk profile and chemical constituents have not been definitively characterized, because they may interest some kids in smoking, and because they may not deliver nicotine at precisely defined quantities.

The Rest of the Story

To the specific subgroup of ex-smokers who have quit by using electronic cigarettes and who are successfully maintaining themselves smoke-free with the help of electronic cigarettes, the FDA is saying: stop using your electronic cigarettes because we do not know how unsafe they are. Instead, throw away your e-cigs and switch to a known entity -- FDA-approved NRT products.

However, the truth is that these are a population of people who have already tried NRT products and found them to be unhelpful in aiding their quit attempts. Many of these ex-smokers have tried NRT multiple times and failed every time. Clearly, if everyone in this population took the FDA's advice, threw away their electronic cigarettes, and switched to NRT, the majority of them would be smoking regular cigarettes by week's end. And by month's end, most of the rest would also be smoking. By year's end, the overwhelming majority of these smokers would have returned to cigarette smoking.

Some recommendation.

Why can't the FDA make a recommendation that makes more sense from both a scientific and a public health perspective? Something like:

"If you have successfully quit smoking using electronic cigarettes, congratulations! You have succeeded in the most important action you can take to improve your health. Because the long-term risks of electronic cigarettes are not completely understood, you may want to consider efforts to wean yourself off electronic cigarettes, or if that is not possible, to wean yourself from a high to a low nicotine cartridge and then down to a zero nicotine cartridge if possible. But in no case should you return to regular cigarettes. You are an ex-smoker and we want you to stay that way for the sake of your health. The FDA has made it an urgent priority to study the safety and efficacy of electronic cigarettes and should we gain any new information which alters the above advice, we will share it promptly. We will be issuing regulations this summer to make sure that the quality control processes used by electronic cigarette distributors are as solid as they can and should be."

No. Instead, the message being sent to these ex-smokers is:

"e-Cigarettes may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death."

"Because clinical studies about the safety and efficacy of these products have not been submitted to FDA, consumers currently have no way of knowing

  • whether e-cigarettes are safe for their intended use,
  • what types or concentrations of potentially harmful chemicals are found in these products, or
  • how much nicotine they are inhaling when they use these products."
The FDA might as well just tell these vapers (i.e., ex-smokers) to throw away their electronic cigarettes and return to regular cigarette smoking. After all, that is the practical effect of the agency's advice to these ex-smokers.

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