Unprecedented in its complexity and scale, a very low nicotine content (VLNC) standard would fundamentally change the design and function of cigarettes, modify the choices and behaviors of more than 38 million U.S. adult smokers, and transform the market. The reduced-nicotine product standard envisioned in the Advance Notice of Proposed Rulemaking (ANPRM) will require significant science and evidence to support FDA’s determination that such a standard would be appropriate for the protection of public health. FDA has stated that it will use the “best available science” to pursue any nicotine product standard. At this time however, there are several fundamental problems. The scientific data on VLNC cigarettes is limited and much of the data that FDA references in the ANPRM is not publicly available. This presentation will focus on the need for science that can be accessed, validated, authenticated, reproduced and challenged in the development of a nicotine standard.