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.

A 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. Thus, smaller tobacco product manufacturers (such as vape shops that engage in some but not all of the activities described in the proposed rule) would be able to tailor their procedures to suit their smaller operations while still complying with the TPMP requirements[7].

With respect to vape shops in particular, the proposed rule clarifies that such establishments that only sell ENDS products and components and parts would not be considered manufacturers and would not be subject to the requirements in the proposed TPMP rule unless they also engage in the manufacture, preproduction design validation, packing, and storage of finished or bulk tobacco products within the meaning of the rule[8]. While vape shop owners will certainly appreciate the compliance extension, it is not clear how many vape shop e-liquid manufacturers will survive the next four years, given the nearly insurmountable PMTA process and FDA’s continued enforcement focus on these small U.S. businesses with de minimis market share.

In addition, while the proposed rule clearly states that TPMPs will apply to foreign manufacturers to ensure that imported tobacco products comply with the TCA and applicable tobacco product standards, it is important to note that the rule does not require foreign manufacturing establishments, including China-based manufacturers largely responsible for producing counterfeit and otherwise illegal disposable ENDS, to register their establishments with or provide a product list to FDA. Section 905(b) of the TCA made this a requirement for domestic manufacturing establishments, but left it up to FDA to extend to foreign manufacturing establishments through the rulemaking process[9]. In other words, FDA is not using the proposed TPMP rule to execute its authority provided by Congress under Section 905(h) of the TCA to promulgate a regulation to extend the registration and product listing requirement to foreign establishments. This also means that foreign manufacturers will not be subject to regular, biennial inspections required for domestic establishments, although the agency has broad authority and ability to inspect foreign manufacturers pursuant to Sections 704 and 905 of the FD&C Act, and as part of the Premarket Tobacco Product Application (PMTA) review process under 21 C.F.R. § 1114.27.  

Summary of Proposed Rule

The proposed rule, which is expected to be codified at 21 C.F.R. Part 1120, establishes a framework of requirements that tobacco product manufacturers to follow, including:

• Establishing tobacco product design and development controls to prevent or minimize certain risks;
• Ensuring that finished and bulk tobacco products are manufactured in conformance with established specifications;
• Minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products;
• Requiring investigation and identification of nonconforming tobacco products, including those that have been distributed, in order to institute appropriate corrective actions, such as conducting a recall as needed;
• Taking appropriate measures to prevent contamination of tobacco products; and
• Establishing traceability to account for all components or parts, ingredients, additives, and materials, as well as each batch of finished or bulk tobacco product, to aid in the investigation and identification of nonconforming tobacco products. 

Specifically, the proposed rule is divided into ten subparts, as follows:

1) Subpart A – General Provisions

Subpart A describes the purpose and scope of the proposed rule. As noted above, the proposed rule applies to both domestic and foreign manufacturers of finished and bulk tobacco products, requiring such manufacturers to adhere to the framework of requirements. 

2) Subpart B – Management System Requirements

Subpart B has three sections, as follows:

• Organization and personnel, which requires establishing and maintaining an organizational structure with sufficient personnel and designated responsibilities, including management personnel with executive responsibility;
• Tobacco product complaints, which requires establishing and maintaining procedures for handling the receipt, evaluation, and documentation of any complaints; and
• Corrective and preventive actions (CAPA) are necessary to protect public health, which requires establishing and maintaining procedures for implementing such actions. 

3) Subpart C – Buildings, Facilities, and Equipment

Subpart C has four sections, as follows:

• Personnel practices, which requires establishing and maintaining procedures related to personnel practices to reduce the risk of contamination with filth biological materials, chemical hazards, or other deleterious substances;
• Buildings, facilities, and grounds, which requires ensuring that buildings and facilities are of suitable construction, design, and location to facilitate cleaning and sanitation, maintenance, and proper operation, as well as ensuring that grounds are maintained in a condition to prevent contamination;
• Equipment, which provides requirements for the design, construction, and maintenance of equipment used in the manufacturing process, as well as requirements for testing, monitoring, and measuring such equipment; and
• Environmental controls, which requires that systems be maintained and monitored to verify that environmental controls are adequate and functional. 

4) Subpart D – Design and Development Controls

Subpart D has two sections, as follows:

• Design and development activities, which requires establishing and maintaining procedures to control the design and development of tobacco products, including the control of risks associated with the product, the manufacturing process, packaging, and storage, as well as procedures for design verification and validation, and requires developing a process for identifying, analyzing, and evaluating known and reasonably foreseeable risks associated with the tobacco product and its packaging and taking appropriate measures to reduce or eliminate risks; and
• Master manufacturing record (MMR), which requires establishing and maintaining an MMR for each finished and bulk tobacco product manufactured for distribution, including tobacco product specifications, manufacturing methods and production process procedures, and all packaging, labeling, and labels approved for use with the product. 

5) Subpart E – Process Controls

Subpart E contains nine sections, as follows:

• Purchasing controls, which requires establishing and maintaining procedures for ensuring that purchased or otherwise received products and services related to the manufacture of finished or bulk tobacco products are from qualified suppliers and conform to established specifications;
• Acceptance activities, which requires establishing and maintaining procedures for incoming, in-process, and/or final acceptance activities, including acceptance criteria, to ensure that products meet established specifications;
• Production processes and controls, which requires establishing and maintaining procedures for production processes, including process specifications and process controls, process validation, and manual methods and manufacturing material;
• Laboratory controls, which requires demonstrating laboratory competency to perform laboratory activities associated with the manufacture of finished and bulk tobacco products and establishing and maintaining appropriate laboratory control procedures;
• Production records, which requires establishing and maintaining procedures for ensuring that a production record is prepared for each batch of finished or bulk tobacco product to demonstrate conformity with the requirements established under the MMR;
• Sampling, which requires establishing and maintaining an adequate sampling plan that uses representative samples based on a valid scientific rationale;
• Nonconforming tobacco products, which requires establishing and maintaining procedures for the control and disposition of nonconforming tobacco products, including specific requirements for identification and segregation, investigation, and disposition and follow-up
• Returned tobacco products, which requires establishing and maintaining procedures for the control and disposition of returned tobacco products, including specific requirements for identification, segregation, evaluation, and disposition; and
• Reprocessing and rework, which provides specific requirements for the evaluation of the tobacco product to determine that it is appropriate for reprocessing or rework, authorization of the reprocessing or rework, and production processes, including process controls, to ensure that reprocessed and reworked tobacco product conforms to MMR specifications. 

6) Subpart F – Packaging and Labeling Controls

Subpart F contains four sections, as follows:

• Packaging and labeling controls, which requires establishing and maintaining procedures for ensuring that the correct packaging and labeling are used to prevent mix-ups, ensuring that all packaging and labeling are approved for use by the manufacturer and comply with all requirements of the MMR as well as other applicable requirements promulgated by FDA, ensuring that packaging and labeling control procedures to ensure that labels are indelibly printed on or permanently affixed to finished and bulk tobacco product packages, and ensuring that the packaging, labeling, storage, and shipping cases do not contaminate or otherwise render the tobacco product adulterated or misbranded;
• Repackaging and relabeling, which requires establishing and maintaining procedures for repackaging and relabeling operations;
• Manufacturing code, which requires applying a manufacturing code that contains the manufacturing date and batch number to the packaging or label of all finished and bulk tobacco products; and
• Warning plans, which requires establishing and maintaining procedures for implementing the requirements of such plans. 

7) Subpart G – Handling, Storage, and Distribution

Subpart G contains two sections, as follows:

• Handling and storage, which requires establishing and maintaining procedures to ensure that tobacco products are handled and stored under appropriate conditions to prevent nonconforming products as well as mix-ups, deterioration, contamination, adulteration, and misbranding of tobacco products; and
• Distribution, which requires establishing and maintaining procedures to ensure that tobacco products are distributed to the initial consignee under appropriate conditions and that only those finished and bulk tobacco products approved for release are distributed. 

8) Subpart H – Recordkeeping and Document Controls

Subpart H requires that all documents and records be maintained at the manufacturing establishment or another location that is readily accessible to responsible individuals of the manufacturer and to FDA and that they be written in English, or an English translation be made available upon request. Additionally, documents and records associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date of distribution of the batch or until the product reaches its expiration date, if one exists, whichever is later, while documents and records that are not associated with a batch of finished or bulk tobacco product must be retained for a period of at least four years from the date they were last in effect. 

9) Subpart I – Small Tobacco Product Manufacturers

Subpart I provides that small tobacco product manufacturers, defined as tobacco product manufacturers that employ fewer than 350 employees, are not required to comply with the proposed rule until four years after the effective date of the Final Rule. 

10) Subpart J – Exemptions and Variances

Finally, Subpart J contains five sections that set forth procedures and requirements for petitioning for a permanent or temporary exemption or variance from any of the proposed requirements. 

Next Steps

The proposed rule is open to public comments for 180 days, until 11:59 PM (Eastern) on September 6, 2023. As part of the rulemaking process, FDA will review all comments received, conduct a comment analysis, and decide whether to (i) proceed with the proposed rule; (ii) issue a modified proposed rule based on the comments received; or (iii) withdraw the proposed rule. Depending on how many comments are received, we anticipate it will take FDA at least two years to finalize the TPMP rule.

FDA will host a public hearing on April 12, 2023, to gather comments from stakeholders, including industry, the scientific community, advocacy groups, and the public. FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18, 2023, to seek recommendations from FDA’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations.

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[1] 88 Fed. Reg. 15174 (March 10, 2023), available at: https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice. 

[2] See United States Food and Drug Administration, “FDA Proposes New Requirements for Tobacco Product Manufacturing Practices” (March 8, 2023), available at: https://www.fda.gov/news-events/press-announcements/fda-proposes-new-requirements-tobacco-product-manufacturing-practices. 

[3] 88 Fed. Reg. 15174, 15253 (March 10, 2023). 

[4] Id. at 15174, 15254. 

[5] The proposed rule indicates that, for purposes of this definition, the number of employees of a manufacturer includes those employees and personnel of each entity that controls, is controlled by, or is under common control with such manufacturer. Id. 

[6] Id. at 15174, 15237. 

[7] Id. at 15174, 15186. 

[8] Id.

[9] See United States Food and Drug Administration, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for Industry” (December 2017), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-and-product-listing-owners-and-operators-domestic-tobacco-product-establishments.