Addressing regulatory barriers to licensing nicotine products for smoking reduction

This paper examines the current regulatory obstacles to extending the permi tted use of NRT, and to include smoking reduction ways of addressing these. There are major differences between different countries in regulations con cerning NRT. These differences appear to be due to different attitudes to c igarette smoking as an issue and different preconceptions about nicotine as an addictive and potentially toxic drug. The paper considers how existing WHO and American Psychiatric Association definitions of mental disorders ma y be used in submitting proposals for use of NRT as an aid to smoking reduc tion and how concerns over safety and abuse and dependence liability can be addressed. It also examines what new evidence may be needed. Coordinating the efforts of the pharmaceutical industry, clinicians and researchers will probably be important in moving regulatory authorities further in the dire ction of accepting NRT for widespread use in smoking reduction.