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This proposed rule would establish content and format requirements to ensure that modified risk tobacco product applications contain sufficient information for FDA to determine whether it should permit the marketing of a modified risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified risk tobacco product application review and require applicants receiving authorization to market a modified risk tobacco product to establish and maintain records, conduct postmarket surveillance and studies, and submit annual reports to FDA.

Statement of Need:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), requires an order under section 911(g) prior to the introduction or delivery for introduction into interstate commerce of any modified risk tobacco product. To receive an order under section 911(g), an individual must submit a modified risk tobacco product application (MRTPA) under section 911(d) of the FD&C Act. If an MRTP is introduced or delivered for introduction into interstate commerce without an order under 911(g) in effect, the product will be deemed adulterated under section 902 of the FD&C Act (21 U.S.C. 387b(8)) and the action is  a prohibited act under sections 301(a) and (pp) of the FD&C Act (21 U.S.C. 331) and may be subject to enforcement action. The MRTPA provisions of this regulation are intended to provide information to manufacturers to aid them in preparing and submitting MRTPAs.

Summary of the Legal Basis:

Section 911 of the FD&C Act mandates the review of modified risk tobacco products, sets forth basic MRTPA content requirements, establishes the standard for whether a modified risk order should be issued, and requires FDA to require postmarket surveillance and studies and reporting by a manufacturer that has received a modified risk order. Section 701 of the FD&C Act authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act and section 704 of the FD&C Act authorizes inspections.

Alternatives:

In addition to the costs and benefits of the proposed rule, FDA assessed the costs and benefits of publishing the proposed rule without including requirements for postmarket reporting, including both periodic reporting and mandatory adverse experience reporting.

Anticipated Costs and Benefits:

The proposed rule is expected to generate annual benefits in the form of cost savings primarily to the FDA with some potential cost savings to applicants. The format and content requirements discussed in this proposed rule will improve the efficiency of FDA’s MRTPA review process, reduce the number of incomplete applications, and reduce the number of deficiency letters and requests for information FDA sends to an applicant to complete a substantive review. Additionally, it is expected that the proposed rule will generate additional cost savings as the formatting and content requirements related to postmarket surveillance and studies (PMSS) are expected to improve the efficiency of the review of PMSS relative to the process that would exist if the proposed rule were not finalized.  The estimated present value of the benefits of the rule range from between $1.39 million and $5.55 million at a 7 percent discount rate with a primary estimate of $3.47 million. At a 3 percent discount rate the estimated present value of the monetized benefits of the proposed rule range from approximately $1.95 million to approximately $7.79 million with a primary estimate of $4.87 million. The costs of the rule include one-time costs associated with the costs of reading the proposed rule. The present value of these costs of the rule is $4.63 million.

Risks: