In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. This rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a premarket tobacco product application (PMTA) to FDA.

The Proposed Rule

Under the proposed rule, importers would be required to submit the STN for any ENDS products into the electronic imports system operated by CBP. An STN is defined as a “number that FDA assigns to submissions that are received from an applicant, such as a PMTA and a supplemental PMTA.” In other words, an ENDS product will not have an STN unless it is the subject of an application submitted to FDA for premarket review. The existence of an STN would only be “one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product,” FDA said in an accompanying press release. Thus, having a PMTA on file with FDA would not be a guarantee of entry.

The submission of STNs for imports of tobacco products, including ENDS, is currently optional. According to the proposed rule, FDA believes that requiring STN submissions for ENDS will “allow the Agency to conserve our resources by reducing the instances of manual admissibility review and to more effectively and efficiently make admissibility decisions.” FDA further explains that the proposal pertains only to ENDS because of the agency’s limited resources. As set out in the proposed rule, FDA’s automated look-up validation process can only perform electronic verification of the STN for ENDS.

Why It Matters

This proposal reflects the present dynamics at FDA with respect to both enforcement activity and practical capabilities. It is the latest rulemaking initiative as part of FDA’s ongoing efforts to curb the illicit ENDS market. We also note that FDA references its strained resources multiple times in the proposed rule—both to justify the need for the rule and to explain its limited scope . Similarly, FDA Center for Tobacco Products (CTP) Director Brian King testified in September before the U.S. House Energy & Commerce Committee’s Health Subcommittee that CTP faced a “critical resource challenge” in light of its user fee-based funding structure. Director King urged the subcommittee to consider indexing current user fees for inflation and granting CTP the authority to assess user fees on manufacturers and importers of all regulated tobacco products.

We will continue to monitor FDA’s messaging regarding CTP’s funding vis-à-vis its regulatory capabilities, especially as the agency’s enforcement efforts against illicit ENDS continue ramping up.

The comment period is open through October 15, 2024. If you have questions about the implications of the proposed rule as it pertains to your business, our team is happy to assist.