FDA Finalizes PMTA and SE Report Rules for Tobacco Products

FDA Regulations Update

The U.S. Food and Drug Administration (FDA) has finalized two foundational rules for companies that are looking to market and sell new tobacco products in the U.S. These rules provide additional information on what the federal agency will be looking for in Premarket Tobacco Applications (PMTAs) and Substantial Equivalence (SE) reports.

When the FDA was granted the power to regulate tobacco products in 2016 through the Family Smoking Prevention and Tobacco Control Act, it was revealed that deemed tobacco products that were considered “new” would either have to prove Substantial Equivalence, meaning the product was very similar to a product that had been on the market before the cut-off date, or a manufacturer would need to file a Premarket Tobacco Application (PMTA) to seek authorization to distribute and market its “new” product in the U.S. Many manufacturers, however, have encountered problems with both processes, stating that the FDA had not clearly stated what information was needed to get approval.

Since the Sept. 9, 2020 deadline, thousands of applications have been submitted to the FDA, representing 6.5 million products. To date, the FDA has taken action on approximately 96 percent of the applications [read more here], with many manufacturers receiving a Marketing Denial Order (MDO). According to the FDA, the finalization of these rules will help ensure future submissions will have the needed information to help the agency determine whether or not these new tobacco products meet the “the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.”

In a press release, acting FDA commissioner Janet Woodcock, M.D., stated: “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. 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.”

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, added: “Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA. 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.”