Former FDA Commissioner Calls for Agency to Mandate 90% Reduction in Nicotine Levels in Cigarettes - Michael Siegel

Former FDA Commissioner Dr. David Kessler, speaking at a forum on the impact of the FDA tobacco law, urged the Agency to mandate significantly lower levels of nicotine in cigarettes. According to an article in the New York Times, he called for a reduction from the current level of about 10 mg per cigarette to less than 1 mg, which would be a reduction of just over 90%.

According to Kessler, mandating this reduction in nicotine levels would bring the nicotine to "non-addictive levels" and would save 200,000 to 300,000 lives a year.

The FDA tobacco law does not allow the Agency to eliminate the nicotine in cigarettes.

The Rest of the Story

Dr. Kessler's recommendation is flawed because of three basic scientific myths inherent in his reasoning:

Myth #1. Nicotine is not addictive below 1 mg per cigarette.

There is no evidence to support the contention that below 1 mg, nicotine-laden cigarettes cease being addictive. This has never been tested in real-life setting, so there is simply no evidence to support the assertion. This assumption flies in the face of what we know about other addictive drugs. For example, addiction specialists who treat alcoholics do not recommend that they cut the amount of alcohol they consume by 90%. They call for complete abstinence. Anything short of this is going to result in activation of brain receptors that are involved in addiction to alcohol. Even at a level of less than 1 mg, there is almost certainly going to be some uptake of nicotine, and some binding to receptor sites in the brain, resulting in at least some activation of the neurochemical systems that produce psychoactive effects that contribute to nicotine addiction.

The only studies that have been conducted on very-low nicotine cigarettes have found that consumers will not maintain smoking these products, but will switch to regular cigarettes. This is not relevant to the mandated reduction of nicotine levels, however, because in that situation, there will be no "regular" cigarettes. There will be no other choice, and it is not clear that smokers will be more likely to quit smoking entirely.

Myth #2: The addiction to smoking is solely due to nicotine.

As I have revealed over the past months in relation to the apparent effectiveness of electronic cigarettes in suppressing the craving to smoke, high levels of nicotine delivery are not necessary to maintain cigarette addiction. A large component of the addiction is behavioral. Many anti-smoking groups are failing to recognize that smoking addiction is more than just addiction to nicotine. In fact, many electronic cigarette users are successful in quitting smoking even with 0 mg nicotine cartridges. There is substantial scientific evidence to suggest that the behavioral aspects of smoking contribute heavily to the addictiveness of smoking. Replacing the nicotine alone is not sufficient to suppress the craving to smoke. Replacing the behavioral aspects of smoking, in the absence of nicotine, can actually suppress the craving. So it is clear that there are both pharmacologic and behavioral aspects to smoking addiction.

Myth #3: Cigarettes would not be smoked if they contained less than 1 mg of nicotine. Many smokers would quit and youth would not initiate smoking.

Myths #1 and #2 lead to the conclusion that if only nicotine levels in cigarettes were cut by 90%, cigarettes would no longer be addictive and therefore most smokers would quit and most youth would not start smoking. Hence, Dr. Kessler's estimate of a reduction in smoking-attributable mortality by a whopping 50 to 75% if nicotine levels are lowered.

Unfortunately, there is no evidence to support this prediction. A 90% reduction in nicotine levels would most likely not result in a non-addictive product, both because there is no evidence that a level below 1 mg is non-addictive and because the nicotine is just one aspect of the addiction to smoking.

What the scientific evidence suggests is the most likely outcome is that cigarette smokers will substantially increase their cigarette consumption in an attempt to try to maintain their current nicotine levels. This increased cigarette consumption will, of course, result in increased disease and deaths -- the exact opposite of what Dr. Kessler promises with his proposed policy.

If you addict rats to nicotine by hooking them up to an infusion mechanism by which they can press a lever to administer a nicotine dose, and then you substantially lower the nicotine level, the rats will not cease pressing the lever. Instead, they will start pressing the lever more often, and more frantically. The same behavior occurs when the dose of any addictive drug is lowered. It is unclear what evidence supports the contention that in the face of a uniform reduction in nicotine levels, cigarette smokers will behave in the exact opposite way of what a scientific knowledge of addiction behavior predicts.

There is abundant scientific evidence that reductions in nicotine levels are associated with compensation -- the phenomenon by which smokers will increase their cigarette consumption (and puffing intensity) to compensate for lower nicotine delivery. This is one of the major reasons why the low-nicotine cigarette myth is a myth.

Let me emphasize that this flawed policy proposal is not Dr. Kessler's fault. It is the result of a flawed law: one that precluded the FDA from eliminating the nicotine in cigarettes. While I am not arguing that elimination of nicotine in cigarettes is a policy that should have been adopted (I have made it clear that I do not favor cigarette ingredient regulation as an appropriate way to tackle the problem at all), the anti-smoking groups should never have agreed to legislation that was intended to lower nicotine levels, but not eliminate the nicotine. Such a policy is exactly what cigarette companies would want because it would increase cigarette consumption as smokers struggle to compensate for the reduced nicotine delivery. Moreover, there is no evidence that lowering the nicotine levels in cigarettes would substantially reduce youth smoking either. The scientific base is simply not existent to support the contention that there is a level below which nicotine would not contribute toward cigarette addiction, or that if there is a level, we know what it is.

The biggest tragedy would be if the FDA adopted Dr. Kessler's advice, reduced nicotine levels by 90%, and it turned out that cigarette consumption greatly increased. It would be even worse if such a policy resulted in a lowering of the public's appreciation of the addictive potential of smoking (it most certainly would have that effect). Such an effect would itself increase smoking rates and could perhaps encourage smoking experimentation among youth because they would mistakenly believe that smoking is no longer addictive and so it is less of a danger to experiment.

Unfortunately, the FDA tobacco law puts forth a regulatory approach that is misguided and cannot actually achieve a significant reduction in smoking-related mortality. Instead, the FDA should concentrate its resources on the only proven way of substantially reducing smoking: by putting all of its tobacco-related resources into a national anti-smoking media campaign, along the lines of the "truth" campaign.