Abuse liability assessment of tobacco products including potential reduced exposure products.

The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREP). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the pre-market assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based.