Government Relations Update
President Barack Obama gave the Food and Drug Administration (FDA) regulatory authority over tobacco by signing the Family Smoking Prevention and Tobacco Control Act in 2009. Since then, many APA scientists have worked hard to see that psychological research has been applied to the law's various mandates, which seek to regulate the way cigarettes and smokeless tobacco products are manufactured, labeled and marketed.
The bulk of that work has been conducted under the auspices of the FDA's new Center for Tobacco Products, which was created by the act, with oversight by the FDA's Tobacco Products Scientific Advisory Committee. Getting psychologists appointed to the advisory committee was critical, and APA's nominations were very well received. FDA selected Jack Henningfield, PhD, of the Johns Hopkins University department of psychiatry and behavioral sciences, and Dorothy Hatsukami, PhD, of the University of Minnesota Masonic Cancer Center, to serve on the inaugural roster.
The advisory committee has been charged with evaluating several areas of interest to psychologists, including:
- The impact of menthol in cigarettes on public health, including its use by children, African Americans, Hispanics and other racial and ethnic minorities.
- The impact of dissolvable tobacco products on the public health, including that of children. (Unlike ordinary chewing tobacco, these products dissolve in the mouth.)
- The effects of manufacturers' alteration of nicotine in tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved.
- Any application to the FDA for modified-risk tobacco products, in which the manufacturer uses such terms as "mild" or "lite" in its packaging to claim that the product is less harmful than traditional tobacco products.
The Family Smoking Prevention and Tobacco Control Act banned the marketing and sale of all flavored tobacco products except menthol in September 2009. In March 2011, a voluminous report on menthol concluded that taking menthol cigarettes off the market would "benefit public health in the United States." That recommendation was based on findings suggesting that although menthol is not toxic on its own, adding it to tobacco products increases the likelihood that people will try the cigarettes and that they will become addicted to them and make it harder for them to quit. This is particularly true for African-American smokers who are more likely to smoke menthol cigarettes.
The advisory committee will take up the use of dissolvable tobacco products in the coming months. Two more of APA's nominees for the committee—Robert Balster, PhD, of Virginia Commonwealth University School of Medicine, and Tom Eissenberg, PhD, Virginia Commonwealth University department of psychology—will participate in those deliberations.
APA and its members are offering psychology's expertise to the Center for Tobacco Products in other ways as well. For one, APA partnered with several other organizations in an effort spearheaded by the Campaign for Tobacco-Free Kids to inform FDA's approach to determining what constitutes "substantial equivalence," in which a tobacco company tries to avoid the rigors of FDA's new product review by saying that all of its products should be grandfathered under the claim that they are substantially equivalent to already-approved products.
Although ingredient manipulation of tobacco products might not seem directly relevant to psychology, adding ammonia or changing the leaf blend to alter a cigarette's nicotine yield can make a cigarette more addictive. As a result, both the FDA and the psychological science community have long been interested in the abuse liability of pharmaceuticals and now, with the Family Smoking Prevention and Tobacco Control Act, have the opportunity to apply that science to the regulation of tobacco products.
The FDA center offers further good news for scientists: In this era of decreased research funding, the center has a budget of $85 million for its first year, $235 million for its second and $450 million for its third, growing eventually to $711 million by its 11th year and beyond. That level of funding will enable FDA to support important new research and help the biomedical and behavioral science community better track the effects of new FDA regulations.
One such initiative is a joint venture between the National Institutes of Health and the FDA called the Tobacco Control Act National Longitudinal Study of Tobacco Users. Investigators will follow more than 40,000 users of tobacco products and those at risk for tobacco use age 12 and older. Researchers will explore such factors as what makes people susceptible to tobacco use, what health problems result from its use and what effects regulatory changes have on people's risk perceptions.
Geoff Mumford, PhD, directs APA's Office of Science Policy.
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