Journal of Health Care Law and Policy   |  January 24, 2021

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The Premarket Tobacco Product Application (PMTA) provisions in the U.S. Tobacco Control Act (TCA) prohibit any new or substantially different types or brands of tobacco products from entering the U.S. market unless FDA first finds that allowing the product’s marketing is “appropriate for the protection of the public health.” Similarly, the Act’s Modified Risk Tobacco Product (MRTP) provisions prohibit the marketing of any tobacco product with modified-risk claims unless FDA first finds that allowing such marketing will reduce health harms and risks to the population as a whole. At a minimum, these public health standards require FDA to determine that allowing the new tobacco product marketing will produce harm reductions (e.g., from prompting smokers to switch to the less-harmful product) which are larger than any new related health harms (e.g., from increasing youth use or prompting smokers to switch instead of quitting all use). Because of the inevitable uncertainties when trying to predict how new tobacco product marketing will affect future consumer behavior and health, the TCA gives FDA considerable discretion as to how it will administer the PMTA and MRTP procedures to protect the public health. As this article explains, however, FDA has failed to exercise that discretion appropriately, and has violated the TCA’s public health standard and other applicable laws in the permissive PMTA and MRTP orders it has issued to date.

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