APA recommends rigorous review of tobacco products

The tobacco industry is claiming that all of its new products are substantially equivalent to existing products

In November, APA partnered with several other organizations dedicated to tobacco control in a recent effort spearheaded by the Campaign for Tobacco Free Kids to inform the Food and Drug Administration’s (FDA) approach to determining what constitutes “substantial equivalence.” Through the notion of substantial equivalence (PDF, 391KB) the tobacco industry is trying to avoid the rigors of FDA’s review of new products by claiming that all of its products should be grandfathered under a claim that they are substantially equivalent to existing products. While ingredient manipulation of tobacco products might not seem directly relevant to psychology, adding ammonia or changing the leaf blend to alter the nicotine yield of a cigarette is fundamentally about shifting the dose response curve of an addictive drug. Both FDA and the psychological science community have long been interested in the abuse liability of pharmaceuticals and now have the opportunity to apply that science to tobacco products.

The FDA’s Center for Tobacco Products (CTP) represents a growth opportunity for the application of psychological research in an otherwise contracting science economy because CTP is funded entirely through a tap on the tobacco industry. With a budget of $85 million in its first year, $235 million in its second, $450 million in its third, it will grow to $711 million by years eleven and beyond. Such largess will allow FDA to support important new research and help the existing biomedical and behavioral science community better track the effects of new FDA regulations.  One such initiative, announced in October, is a joint venture with the National Institutes of Health (NIH) called the Tobacco Control Act National Longitudinal Study of Tobacco Users. Investigators will follow more than 40,000 users of tobacco-product and those at risk for tobacco use ages 12 and older. As described in the FDA press release, “They will examine what makes people susceptible to tobacco use; evaluate use patterns and resulting health problems; study patterns of tobacco cessation and relapse in the era of tobacco regulation; evaluate the effects of regulatory changes on risk perceptions and other tobacco-related attitudes; and assess differences in attitudes, behaviors and key health outcomes in racial-ethnic, gender, and age subgroups.” In addition, NIH recently released two funding announcements, for R01 grantees and for U01 grantees, for “Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act” to expand research on tobacco products. The sponsoring Institutes are NCI, NHLBI, NIDA, NIEHS and NIMH.