Tobacco Product Standard for Nicotine Level : Protecting Against Unintended Consequences by Expanding the Scope of the Rule to All Inhaled Recreational Nicotine Products Docket No . FDA-2017-N-6189

This comment details how the proposed product standard can create unintended public health harm if the standard is written in a way that can be used by the tobacco industry to simply shift the mix of dangerous products that it markets to continue to build its markets. Specifically, if the nicotine product standard for cigarettes or even all combustible tobacco products is not implemented in the broader context of the entire recreational nicotine market, the product standard could create substantial public health risks. FDA must develop the standard in a way that explicitly considers that: 1) e-cigarettes and other non-combusted nicotine products do carry health risks, and 2) FDA resources must be devoted to targeted public education campaigns and concurrent regulatory action to ensure that the combustible product standard does not inadvertently increase nicotine use among youth and young adults.