Acting on FDA's Authority to Limit Nicotine in Smoked Tobacco Products: Is It a Viable Pathway to a Smoke-free Society?

The Family Smoking Prevention and Tobacco Control Act ("Act") of 2009 authorizes the U.S. Food and Drug Administration to promulgate product standards for nicotine yields of smoked tobacco products. The Act further authorizes the FDA's Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations on the effects of the alteration of nicotine yields from tobacco products and on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved. While a single threshold may not apply to the entire population, minimal nicotine yields akin to those found in nightshade vegetables should be below any dependence threshold. An additional challenge is to determine the relative public health implications of a phased reduction versus a one-time reduction in nicotine yields. While a phased reduction mitigates the withdrawal symptoms of current smokers, compensatory smoking behaviors may create additional health risks. This presentation addresses policy concerns that such a regulatory approach would create some of the unintended consequences associated with drug and alcohol prohibition. A critical distinction from Prohibition and criminal drug policy is that nicotine itself would not be prohibited. Rather, only the most lethal form of nicotine delivery would be subject to regulation. Under the Act, the Secretary of Health and Human Services must consider the public health benefits of a proposed tobacco product regulation. Such a regulation would appear to have the potential to transform the tobacco control landscape by dramatically reducing risk to smokers and smoke exposure of others.