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By Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Services

Over 12 years after the FDA began regulating tobacco products, the long-anticipated Tobacco Product Manufacturing Practices (TPMP’s) have been proposed. The new requirements were proposed by the FDA on March 8, 2023, and the proposed rule is available for public comments for 180 days. FDA has stated their intention with the proposal is to ensure that tobacco products conform to established specifications and to help prevent the manufacture and distribution of contaminated or otherwise nonconforming products, thereby assuring that the public health is protected and that tobacco products comply with the requirements in chapter IX of the FD&C Act.

The proposed TPMP’s are structured very similarly to other industries’ cGMP’s (Current Good Manufacturing Practices) and have 10 subparts or categories. The main requirements of the TPMP’s include establishing product design controls to minimize risk, ensuring products are manufactured in conformance with specifications, minimizing manufacture and distribution of nonconforming products, investigating nonconformances and establishing corrective actions including recalls, preventing contamination, and establishing traceability. The 10 subparts would be: General Provisions; Management System Requirements; Buildings, Facilities, and Equipment; Design and Development Controls; Process Controls; Packaging and Labeling Controls; Handling, Storage, and Distribution; Recordkeeping and Document Controls; Small Tobacco Product Manufacturers; and Exemptions and Variances.

The proposed rule would apply to all finished and bulk tobacco product manufacturers (foreign and domestic) subject to the rule (including specification developers, contract manufacturers, and repackagers/relabelers). It would define “tobacco product manufacturer” to mean “any person(s), including a repacker or relabeler, 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. The manufacture of a tobacco product includes establishing the specifications of or the requirements for a tobacco product.” Proposed definitions of finished and bulk tobacco products would include finished and bulk components or parts of tobacco products, but do not include accessories. The proposed rule would apply to vape shops if they engage in the manufacture of tobacco products (i.e. if they mix or prepare e-liquids or create or modify aerosolizing apparatuses for direct sale to consumers for use in ENDS).

The rule will become effective 2 years after it is published in the Federal Register. Those manufacturers meeting the definition of small product manufacturers (fewer than 350 employees) will have an additional 4 years (for a total of 6 years) to be compliant with the TPMP’s. The FDA held a public oral hearing on April 12 to gather comments from stakeholders, including industry, the scientific community, advocacy groups, and the public. Additionally, the FDA will hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. The FDA will review all public comment prior to finalization of the rule.

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