The U.S. Food and Drug Administration (FDA) finalized two foundational rules for the premarket review of new tobacco products.
These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn, M.D.
“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.
A PMTA is a type of application for any new tobacco product seeking an FDA marketing order. The FDA expects all premarket applications for electronic nicotine delivery systems (ENDS) products will be submitted through the PMTA pathway. However, the FDA has also issued authorizations for combustible cigarettes, smokeless tobacco and non-combusted cigarettes through the PMTA pathway.
Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The agency’s evaluation includes such things as reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled, findings from consumer perception research (if conducted), and the applicant’s description of marketing plans for the product.
The PMTA final rule helps ensure these applications contain sufficient information for the FDA’s evaluation, including details on the physical aspects of a tobacco product and information on the product’s potential public health risks. The final rule describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application. It also formalizes both the procedures the agency will follow when reviewing PMTAs and the postmarket reporting requirements for applicants that receive marketing granted orders. The final rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
In addition to content and format requirements, the final rule formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections. The final rule also describes PMTA-related requirements for submitting application amendments, the time for review, withdrawal of applications, changes in ownership, post-market reporting, the maintenance of records, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements.
The final rule also explains how applicants may submit a supplemental PMTA or a resubmission, which would improve efficiency in certain situations by not requiring the submission of a new PMTA. For example, a supplemental PMTA could be submitted when an applicant is seeking authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order. A resubmission can be submitted to address application deficiencies following the issuance of a marketing denial order.
The FDA has finalized this rule after receiving and reviewing comments during the public comment period for the proposed rule, issued on Sept. 20, 2019. The final rule is based on the agency’s experience reviewing several types of premarket applications, including SE Reports, requests for exemptions from demonstrating SE, modified risk tobacco product (MRTP) applications, and PMTAs. The FDA has received and reviewed thousands of premarket applications for tobacco products, that range widely in the level of detail they contain. This experience has been helpful in developing the rule, which describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application.
