The Food and Drug Administration (FDA) is issuing a proposed rule that would establish requirements for manufacturers of finished and bulk tobacco products on the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation, packing, and storage of tobacco products. The tobacco product manufacturing practice (TPMP) requirements described in the proposed rule are intended to ensure that tobacco product manufacturers control the design and specifications of finished and bulk tobacco products, providing a level of assurance of conformity in the production of tobacco products to established and required specifications that does not occur in the existing market for tobacco products, to prevent the adulteration and misbranding of finished and bulk tobacco products, and establish controls for traceability purposes.

If finalized, full compliance with the proposed rule would have annualized costs of about $27.0 million per year at a seven percent discount rate and $28.2 million at a three percent discount rate over a 10-year period. Annualized benefits would be about $27.2 million per year at a seven percent discount rate and $29.9 million at a three percent discount rate. 

Regulatory Impact Analysis

Requirement for Tobacco Product Manufacturing Practice, Preliminary Regulatory Impact Analysis (PDF 4,287 KB) 

Federal Register: 88 FR 15174, March 10, 2023
Docket: FDA-2013-N-0227