247386 Acting on FDA's Authority to Limit Nicotine in Smoked Tobacco Products: Is It a Viable Pathway to a Smoke-free Society?

Tuesday, November 1, 2011

Mark A. Gottlieb, JD , Public Health Advocacy Institute / AAP Richmond Center, Boston, MA
Patricia Davidson, JD , Public Health Advocacy Institute, Northeastern University, Boston, MA
Richard A. Daynard, JD, PhD , Northeastern University School of Law, Boston, MA
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.

Learning Areas:
Chronic disease management and prevention
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Describe how the U.S. Food and Drug Administrative new regulatory authority over tobacco products explicitly permits it to require manufacturers to reduce nicotine content to non-addictive levels. Differentiate nicotine reduction in smoked tobacco products from federal efforts to eliminate drugs of abuse and alcoholic beverages. Analyze the challenges to such a rulemaking process as well as its implications for public health.

Keywords: Tobacco Policy, FDA

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have conducted tobacco policy research in the area of product regulation for more than 10 years.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.