I have asserted for some 20 years that nicotine, while addictive, is otherwise without significant adverse health effects outside of pregnancy. It is, in other words, safe to consume. In my 1995 book, For Smokers Only, I compared nicotine to caffeine, another addictive drug used safely by millions of people.

Scientific evidence of nicotine’s safety, however, is hard to document, despite the fact that it is one of the most comprehensively studied drugs. The problem is that drug safety is primarily established by the absence of adverse effects. Owing to tobacco prohibitionists’ persistent demonizing of nicotine, only a small number of medical researchers have come forward to express positive views on nicotine safety.

At a 1997 United Nations roundtable on the social and economic aspects of smoking reduction through the use of alternative nicotine delivery systems, nicotine and tobacco experts came to the following conclusions:

Ken Warner, a well-respected tobacco economist at the University of Michigan, wrote about tobacco harm reduction in Nicotine & Tobacco Research in 2002, citing Neal Benowitz’s 1998 book Nicotine Safety and Toxicity:

Although the evidence is not yet definitive, the best scientific judgment to date is that, outside of pregnancy, long-term use of nicotine, in the doses at which people self-administer it, does not pose substantial risks to health.

Finally, Mitch Zeller commented on the spectrum of risks related to various forms of nicotine delivery in a Tobacco Control article published in 2009:

There is a very pronounced continuum of risk depending upon how toxicants and nicotine, the major addictive substance in tobacco, are delivered. Cigarette smoking is undoubtedly a more hazardous nicotine delivery system than various forms of noncombustible tobacco products for those who continue to use tobacco, which in turn are more hazardous than pharmaceutical nicotine products. There is potential for an ever-wider range of consumer-acceptable alternatives to the cigarette for smokers who will not otherwise cease their dependence on nicotine.

Zeller, now director of the FDA Tobacco Products Center, acknowledges nicotine’s safety and tobacco harm reduction’s potential. One hopes that FDA’s regulatory actions will ensure that all Americans are equally well-informed.

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