FDA Finalizes Guidance for New Tobacco Product Authorization

Rules provide additional information on filing PMTAs, SEs
FDA Approved
Photograph: Shutterstock

SILVER SPRING, Md. —The U.S. Food and Drug Administration (FDA) finalized two foundational rules that guide how a manufacturer can seek marketing authorization for a new tobacco product.

The 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, the FDA announced Tuesday.

The agency received thousands of premarket applications for tobacco products since Sept. 9, and the applications ranged widely in the level of detail they contained, the FDA said. This experience, along with public comments, helped the agency develop the rules.

“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, director of the FDA’s Center for Tobacco Products (CTP). “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”

Under the PMTA pathway, tobacco manufacturers or importers must demonstrate to the FDA that marketing of the new tobacco products would be appropriate for the protection of public health.

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 its potential public health risks. It also requires tobacco product manufacturers to keep records establishing their tobacco products are legally marketed, the FDA said.

In addition, the final rule for PMTAs formalizes the general procedures the FDA follows when evaluating the applications, among other steps.

The FDA expects all premarket applications for electronic nicotine delivery systems (ENDS) to be submitted through the PMTA process, but other tobacco products can also take this route. The most common path for cigarettes, smokeless tobacco, cigars, hookah tobacco and roll-your-own tobacco products will be the SE process, the FDA said.

For a new tobacco product to be found substantially equivalent, the FDA must determine that it has the same characteristics as a predicate tobacco product or does not raise different questions of public health. Similar with the PMTAs, SE applications turned into the FDA range in the level of detail they include.

The SE final rule provides additional information on the minimum requirements for the content and format of SE reports, which in the end will make the process more predictable and efficient, the FDA said.

Both rules are effective 30 days after publication in the Federal Register. For more information, visit the FDA’s website.

The FDA said it intends to provide a detailed update on the agency’s progress in reviewing PMTAs and SEs in “coming weeks.”

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