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The FDA Finalizes Two Rules for PMTAs

The U.S. Food and Drug Administration (FDA) has issued two new rules reflecting slight revisions, but no substantive changes, to the PMTA process.

Diane Caruana

October 19, 2021

These rules are meant to ensure that all future submissions contain the basic information needed to meet the relevant premarket requirements efficiently and effectively.

The issued rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports, the two most commonly used pathways through which manufacturers can obtain marketing authorizations for new tobacco products.

These rules aim to ensure that all future submissions contain the basic information needed to determine whether new products meet the relevant premarket requirements efficiently and effectively. “These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said Acting FDA Commissioner Dr. Janet Woodcock.

“The FDA is committed to protecting 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. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States,” she added.

Director of the FDA’s Center for Tobacco Products, Mitch Zeller, added that these new rules should make the process more efficient for applicants. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country,” he said.

More applications for disposables than open systems

In other news, a recent release by ECigIntelligence who analysed data from over 6 million submissions received by the FDA, highlighted that this analysis shows that there were many hundreds more applications for the simpler disposable and cigalike devices than for open system hardware. These type of products tend to come from large companies such as tobacco manufacturers, while open systems tend to be produced by smaller specialist businesses.

Of some 200 open system brands available today, only about 30 have filed PMTA applications to the FDA. Even if all these are approved, that disparity implies that about 85% of open system hardware brands will soon be removed from the market. “This may indicate the discouragement non-tobacco companies face when applying for PMTA approval,” said ECigIntelligence managing director, Tim Phillips.

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