Conference on abuse liability and appeal of tobacco products: Conclusions and recommendations

Abstract

The rate of initiation and progression to dependence and premature mortality are higher for tobacco products than for any other dependence producing substance. This is not explained simply by the addictiveness (“abuse liability”) or by enticing product designs (“product appeal”) alone, but rather by both of these factors in combination with marketing and social influences that also influence “product appeal”. A working meeting of leading experts in abuse liability (AL) and product appeal was convened to examine how these disciplines could be more effectively applied to the evaluation of tobacco products for the purposes of regulation that would include setting standards for designs and contents intended to reduce the risk of initiation and dependence. It was concluded that abuse liability assessment (ALA) is a validated approach to testing pharmaceutical products but has not been extensively applied to tobacco products: such application has demonstrated feasibility, but special challenges include the diverse range of products, product complexity, and the absence of satisfactory placebo products. Consumer testing for product appeal is widely used by consumer product marketers as well as by researchers in their efforts to understand consumer product preferences and use but has not been extensively applied to tobacco products except by the tobacco industry. Recommendations for testing, methods development, and research were developed. A major recommendation was that tobacco products should be tested for AL and product appeal, and the results integrated and evaluated so as to more accurately predict risk of initiation, dependence, and persistence of use.

Introduction

Use of tobacco products is driven by their appeal or attractiveness to potential consumers and sustained by their pharmacological addiction or dependence potential (Food and Drug Administration, 1995, Food and Drug Administration, 1996, World Health Organization, 2007). Addiction potential and product appeal vary widely among tobacco products and can be manipulated by their design, manufacture, and marketing (Food and Drug Administration, 1995, Food and Drug Administration, 1996, Hilts, 1996, Hurt and Robertson, 1998, Kessler, 2001, Slade et al., 1995, World Health Organization, 2001, World Health Organization, 2007). Pharmacologically based addictiveness is typically referred to as abuse liability (AL) or abuse potential, and testing procedures for quantifying these properties are referred to as ALA or abuse potential assessment⁴ (Expert Panel, 2003, Schuster and Henningfield, 2003a, Schuster et al., 2009, Food and Drug Administration, 2010a). ALA methods have evolved over approximately one half a century in efforts to understand and control drug addiction and to provide the science foundation for the regulation of addictive drugs including how drugs should be formulated, labeled, and marketed (Balster and Bigelow, 2003, Expert Panel, 2003, Food and Drug Administration, 2010a, Grudzinskas et al., 2006, Schuster and Henningfield, 2003b, Sellers and Schuster, 2006).

The appeal or attractiveness of products to potential and current consumers is often referred to as “consumer appeal,” “product appeal,” or “product attractiveness,” and is related to a broad range of factors. These include the following: the sensory characteristics of products including taste, smell, or other sensory effects; advertising and promotion efforts; image; cost; the targeted population; positioning among other products; and statements in the form of claims and warnings related to benefits and risks which can increase or decrease product appeal respectively (National Cancer Institute, 2008, Rees et al., 2009, Slovic, 2001, Food and Drug Administration, 2010b).

Tobacco companies integrate both the pharmacologically addicting potential of their products and factors modulating consumer appeal into the design, manufacture, and marketing of their products to increase the population prevalence, volume of use, and market share (Food and Drug Administration, 1995, Food and Drug Administration, 1996, World Health Organization, 2001, World Health Organization, 2007). Outside of tobacco companies, however, experts in addiction and experts in product appeal do not commonly collaborate and they tend to utilize differing theoretical models and methods. Yet it is becoming increasingly evident that progress in understanding the determinants of tobacco product use and in developing more effective interventions to control tobacco product use will require concerted collaboration among experts in abuse liability and experts in product appeal.

These issues are of global relevance in efforts to control tobacco use and reduce tobacco-attributable morbidity and mortality as discussed in the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) (World Health Organization, 2005). The WHO Tobacco Product Regulation Study Group has acknowledged the importance of the assessment abuse liability (“dependence potential”) and consumer product appeal in developing policies and regulations to reduce tobacco use and associated disease (World Health Organization, 2007). In 2010, The Fourth Conference of the Parties to the WHO FCTC discussed the urgency of developing guidelines for tobacco product regulation for “reducing tobacco-attributable disease and premature death by reducing the attractiveness of tobacco products, reducing their addictiveness (or dependence liability) or reducing their overall toxicity.” (Conference of the Parties, 2010, p. 5). The European Union has also recognized the urgency of progress in this area and, in 2010, finalized a report concluding that there is a need to develop specific criteria and methods for assessing “addictiveness” and “attractiveness” of tobacco products (Scientific Committee on Emerging and Newly Identified Health Risks, 2010).

In the United States, the enactment of the Family Smoking Prevention and Tobacco Control Act (hereafter referred to as the “Tobacco Control Act” or the “Act”) has increased the urgency for advances in the ability to identify and quantify factors that increase product use and addictiveness, regardless of whether those factors are pharmacological, or based on product marketing, product flavoring or other factors (United States Congress, 2009). The Act requires the FDA to consider “initiation,” “dependence,” “cessation,” and “effects on the population” in the development of regulations and standards to control the contents and emissions from tobacco products, as well as in the evaluation of new products and in the evaluation of potential claims for putative modified risk tobacco products. The FDA cannot simply evaluate products by their impact on individuals who continue to use the product but must also evaluate the potential impact at the population level on factors such as the risk of dependence development (United States Congress, 2009).

A major challenge to reducing tobacco-attributable disease and death, therefore, is to identify and apply the relevant science from the realm of ALA to the new world of science-based tobacco product regulation. This report is intended to serve WHO in its efforts to guide implementation of the FCTC, and the United States FDA, the European Union and other governmental organizations in their efforts to regulate tobacco products. The report is also intended to serve scientists and research funding organizations by identifying areas in which research is needed to more effectively regulate tobacco products.

The Conference on the Abuse Liability and Appeal of Tobacco Products brought together leading experts from addiction science and drug and tobacco product regulation with experts in the psychology of product perception, product appeal, and marketing. Members of the program planning committee, which included the funders, sponsors, and organizers of the conference, identified presenters who were primarily non-industry scientists and participants who represented a breadth of disciplines. The program planning committee members were asked to provide advice as to the structure of the program, topics to be covered, and to recommend experts to provide the most authoritative, insightful, and balanced perspectives. The program is shown in Table 1; the program planning committee is listed in the Acknowledgements; the complete listing of participants is provided in Supplemental Materials. The goal of the conference was to address challenges in the development of recommendations to more effectively control and regulate tobacco products based on a better understanding and application of the science of ALA and the science of product appeal assessment. The financial and institutional sponsors and program committee for the conference are listed in the Acknowledgements. The state of the science, the applicability and limitations of extant methods of product assessment, and research needs were presented through background papers, presentations, and panels of experts as summarized in Table 1.