View Rule

The rule is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health.

Statement of Need:

The TPMP requirements would be similar to the good manufacturing practice requirements in place for other FDA-regulated products.  This rule would protect public health, including by minimizing the likelihood of the manufacture and distribution of nonconforming tobacco products.  In addition, it would provide a critical means to help assure that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act.  It is also one of the foundational rules that FDA announced as part of FDA’s comprehensive plan for nicotine and tobacco.

Summary of the Legal Basis:

Section 906(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387f(e)) states that in applying manufacturing restrictions to tobacco, FDA shall prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice (cGMP), or hazard analysis and critical control point (HACCP) methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through 387u). The requirements in this proposed rule flow from this authority and serve these goals of protecting public health and ensuring compliance with chapter IX.  Sections 902, 903, 909, and 801(a) of the FD&C Act also provide legal authority for this proposed regulation.

Alternatives:

FDA considered four regulatory alternatives: (1) To require manufacturers to implement a complete HACCP system in addition to the requirements of the proposed rule, 2) To expand coverage of this proposed rule to include manufacturers of all tobacco products, including tobacco products for further manufacturing beyond bulk products, 3) To require manufacturers to implement a complete HACCP system instead of the requirements of the proposed rule, and 4) To implement the Tobacco Industry Stakeholders’ Proposal for a Tobacco Product Good Manufacturing Practices Regulation, as submitted to FDA, instead of the proposed rule.

Anticipated Costs and Benefits:

Estimated benefits of the proposed rule arise from the value of reduced adverse events due to nonconforming finished and bulk tobacco products and from the reduction of costs associated with reduced product recalls and market withdrawals.  We estimate the mean present value of benefits annualized over 10 years using a 7 and 3 percent discount rate to be $ 78.2 million and $85.9 million.  Initial and recurring costs from this proposed rule arise from conducting tasks associated with establishing and maintaining procedures for various aspects of the manufacturing, preproduction design validation, packing and storage processes. We estimate the mean present value of costs annualized over 10 years using a 7 and 3 percent discount rate to be $ 35.2 million and $ 36.3 million.  Estimated annualized benefits that would be generated by this proposed rule exceed estimated annualized costs generated by this proposed rule.

Risks: