FDA Publishes Proposed Rule on Tobacco Product Manufacturing Practices

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On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize and prevent additional risks associated with such products and apply to both domestic and foreign manufacturers of finished and bulk tobacco products.

finished tobacco product is defined as a tobacco product, including any component or part, sealed in packaging, such as a pack of cigarettes, intended for consumers, while a bulk tobacco product is defined as a tobacco product that is not sealed in final packaging but is otherwise suitable for consumer use[3]. A tobacco product manufacturer is defined as any person(s), including a repacker or relabler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished or bulk tobacco product for sale or distribution in the United States[4]. Of note, under the proposed rule, small tobacco product manufacturers, defined as a manufacturer that employs fewer than 350 employees[5], would not need to comply with the TPMP requirements until four (4) years after the effective date of the final rule. FDA notes that this is consistent with Section 906(e)(1)(B)(v) of the Food, Drug and Cosmetic (FD&C) Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), and would provide small businesses with sufficient time to implement the proposed requirements[6]. Moreover, manufacturers would only be required to comply with requirements applicable to its finished and bulk tobacco product manufacturing operations.


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