This paper analyses the particular challenges that tobacco control poses for health governance in an era of accelerating globalisation. Traditionally, health systems have been structured at the national level, and health regulation has focused on the needs of populations within individual countries. However the increasingly, global nature of the tobacco industry, and the risks it poses to public health, require a transnational approach to regulation. This has been the rationale behind negotiations for a Framework Convention on Tobacco Control (FCTC) by the Tobacco Free Initiative of the World Health Organisation (TFL/WHO). In recognition of the need to go beyond national governments, and to create a governance mechanism that can effectively, address the transnational nature of the tobacco epidemic, WHO has sought to involve a broad range of interests in negotiations. The contributions of civil society groups in particular in the negotiation process have been unusual. This paper explores the nature and effectiveness of these contributions. It concludes with an assessment of whether the FCTC constitutes a significant shift towards a new form of global health governance, exploring the institutional tensions inherent in attempting to extend participation within a state-centric organisation.