U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
“Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products of the Agency’s efforts to protect Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law.
Both final rules will publish on October 5 and are effective November 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules. There are no substantive changes from their original publication on January 19, 2021 and subsequent withdrawl as required by a January 20, 2021 memo from the White House Chief of Staff ordering the withdrawal of any rules that did not publish in the Federal Register by noon on that day.
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 the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections. It also outlines, among other things, requirements for submitting application amendments, the time for review, withdrawal of applications, postmarket reporting requirements for applicants that receive marketing granted orders, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements. It also allows for a supplemental PMTA as opposed to a new submission in cases such as authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order.
The SE final rule provides additional information on the requirements for the content and format of SE reports, allowing for greater predictability and efficiency for all stakeholders by providing applicants with a better understanding of the level of detail that an SE report must contain for the FDA to evaluate the comparison of the new tobacco product to a predicate tobacco product. It also addresses the FDA’s communications with the applicant, the retention of records that support the SE report, confidentiality of an SE report, how an applicant can amend or withdraw an SE report, how an applicant may transfer ownership of an SE report to a new applicant and electronic submission of the SE report and amendments.
The FDA continues to conduct premarket review of thousands of applications, which represent more than 6.5 million products, including those submitted on or before the September 9, 2020 deadline. To date, the FDA has taken action on over 96% of the applications submitted by that deadline, including issuing marketing denial orders for more than one million flavored ENDS products. The FDA will continue working to review all pending and incoming applications and remains committed to providing continued regular updates to the public about our premarket review as well as compliance and enforcement actions related to deemed tobacco products.