Toward a comprehensive policy on nicotine delivery products and harm reduction

Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, which includes a scientific evidence based process to characterize tobacco harm reduction products. The existence of the Act has also served as a catalyst for debate on nicotine delivery products in general, including nicotine replacement therapy (NRT) products, and new products such as dissolvable tobacco and the electronic cigarette. Although presently the Act only regulates tobacco products--not NRTs, and not currently electronic cigarettes--it has served as an impetus for science and policy discussions focused on the fundamental public health concepts of harm reduction and continuum of risk. The regulatory environment is certainly changing with tobacco in the US, and also with medicinal nicotine products in the UK--and change could continue globally as science and public health policy evolve. In the US, the Modified Risk Tobacco Product (MRTP) provisions of the Tobacco Control Act provides a process for companies to apply for harm reduction status of a product, and in the UK Medicines and Healthcare products Regulatory Agency (MHRA) is scheduled to issue a final report in 2013 that will assess and act on the regulation of nicotine containing products, including the electronic cigarette. This article suggests that FDA develop a comprehensive policy on nicotine delivery products. Currently FDA is moving forward, but on three separate tracks: examining the risks and benefits associated with the long-term use of NRTs; evaluating evidence submitted by companies seeking to have a tobacco product be characterized as a MRTP; and considering how best to regulate e-cigarettes.