Challenges and considerations related to human abuse liability testing for tobacco products: opportunities to establish tobacco-specific methods, measures, and evaluation criteria
The U.S. Food and Drug Administration (FDA) recommends that tobacco product manufacturers provide information regarding the abuse liability of tobacco and nicotine-containing products to support pre-market tobacco, modified risk tobacco product and substantial equivalence applications. While many methods exist, no standard tobacco product abuse liability assessment methodology has been established and no formal guidance document for such testing has been issued. The CORESTA Product Use Behavior subgroup previously reviewed the FDA’s recommendations in the context of published literature and information from authoritative bodies related to the abuse liability of tobacco and pharmaceutical products, and identified, summarized, and published a review of the most promising approaches for abuse liability assessment of tobacco products. The recommended approaches apply traditional abuse liability testing methods for pharmaceutical products to tobacco and nicotine-containing products and have been implemented for testing of tobacco products, some of which have received FDA marketing granted orders. However, current data reveals opportunities to enhance methods and measures employed in these tobacco abuse liability studies and interpretation of results. We will highlight these opportunities and discuss considerations for establishing standard measures and methods that may better account for unique aspects of tobacco and nicotine-containing products. Special emphasis will be placed on considerations for how information from tobacco abuse liability studies can be used to evaluate whether the marketing of a product is appropriate for the protection of public health.