Appropriate for the Protection of the Public Health: Why We Need Electronic Nicotine Delivery System Product Standards

Brian F. Yagi, Boris Lushniak & Brian J. Miller


Combustible tobacco products (e.g., cigarettes and cigars) continue to be one of the leading causes of preventable disease, disability, and death in the United States. Despite over a century of understanding the harms of tobacco products, a combination of political, policy, and legal battles delayed federal tobacco product regulation until the passage of the 2009 Family Smoking Prevention and Tobacco Control Act. The Act created a new center within the U.S. Food and Drug Administration (FDA), the Center for Tobacco Products (CTP), responsible for reviewing and granting marketing authorization for tobacco products based upon a novel regulatory standard “Appropriate for the Protection of the Public Health” (the APPH standard). A novel legal standard for federal regulators, the APPH standard has never been interpreted by ” the judicial branch. CTP has struggled to interpret and apply it, especially as it relates to Electronic Nicotine Delivery Systems (ENDS products or e-cigarettes).

In December of 2022, the Reagan-Udall Foundation completed its third-party review of CTP’s thirteen-year history and found multiple policy and operational gaps. Specifically, the report criticized CTP for a lack of transparency and timeliness in its approach to harm reduction (that is, promoting the use of tobacco products that are less dangerous than combustibles, such as smokeless tobacco and ENDS products). It repeatedly encouraged CTP to shift from a reactive to proactive state by, inter alia, publishing objective product standards for premarket authorization that would satisfy the statutory definition of “Appropriate for the Protection of the Public Health.” This Article is the first to suggest such objective product standards for ENDS products. It does so by a thorough review of both scientific evidence and legal precedent in administrative law. Promulgation of objective product standards for ENDS products would enshrine harm reduction into the Appropriate for the Protection of the Public Health standard underlying tobacco regulation, providing regulatory clarity for advocates, industry, and policymakers.