FDA's Center for Tobacco Products is starting to ramp up its PMTA actions.

The Food and Drug Administration’s Center for Tobacco Products (CTP) is starting to ramp up its actions after Bret Koplow was appointed interim director in the spring. In July, the FDA issued premarket tobacco product application (PMTA) marketing granted orders (MGOs) for Juul pods and device, which included Juul pods Virginia Tobacco 3% and 5%, Juul pods Menthol 3% and 5% and Juul device. In authorizing the MGO, the FDA has determined that these products “are appropriate for the protection of public health.”

There are now 39 vapor products and devices that have received an MGO and two flavored (menthol) vapor products to receive authorization. It is also noteworthy because Juul’s original application was denied in 2022. After court action, the FDA was required to re-review the PMTA application. In the coming months, it is expected that the CTP will issue more PMTA decisions on the thousands of remaining vapor and nicotine pouch product applications.

In Congress, the U.S. Senate Appropriations Committee approved a Fiscal Year 2026 Agriculture FDA appropriations package, which includes increased enforcement funding of $200 million allocated to combat illicit flavored disposable e-cigarettes and nicotine pouch products illegally imported into the United States. The package also includes language expressing the committee’s concern that the FDA has not completed its review of PMTA applications and urges the FDA to promptly complete this process. The spending bill heads to the full Senate for further consideration. Both federal developments are positive. 

The National Association of Tobacco Outlets (NATO) co-signed a letter to the White House with other national trade associations asking for action from the FDA. The letter called for:

• Requiring CTP to decide all premarket applications: CTP should render decisions, and fast. Many products awaiting decisions are very similar to already authorized products and should be easy to authorize. Regardless of which way these are decided, however, process clarity is better than uncertainty. Even denials will at least start the process of legal challenges and getting to final decisions.

• Requiring CTP to provide clarity: CTP must be told to reveal exactly which products (not just manufacturers) have been denied, exactly which products remain in legal limbo and exactly which products submitted timely applications. The majority of stores in the United States are small businesses that need clear and concise information from CTP.

• Supercharging the multi-agency task force: Once product clarity has been provided, the federal multi-agency task force led by FDA and DOJ, which was established in June of 2024, to combat illicit vapes, should be directed to bring the strongest civil and criminal enforcement actions against the worst offenders to deter ongoing noncompliance.

• Requiring more from U.S. Customs and Border Protection (CBP): CBP should strengthen its efforts to prevent the importation of illicit Chinese vapes by increasing targeted inspections throughout the supply chain, expanding the use of risk-based analytics tools and pursuing civil and criminal penalties in cases of fraudulent import misdeclarations.