WVS NEWS: Will the new FDA import rule for ENDS products really streamline the process?

Written by Antonia Di Lorenzo || Ecigintelligence.com

The US Food and Drug Administration (FDA) and Department of the Treasury have recently proposed a new rule that could significantly impact the importation process for electronic nicotine delivery systems (ENDS) into the country.

According to the FDA, this new requirement – which means importers must submit the FDA-issued submission tracking number (STN) for ENDS products into the Customs and Border Protection (CBP) electronic imports system – would help streamline the process of reviewing the admissibility of ENDS products into the US.

The FDA’s intent behind this rule is clear: to make the process of reviewing ENDS products more efficient and robust. The idea is this could lead to faster processing times and fewer non-compliant products entering the market. But the success of the initiative will depend on several factors, including the readiness of the involved systems, the adaptability of importers, and the effectiveness of the public consultation period, which is open until 15th October.

Promises of a smoother system

The proposed rule, officially titled Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products, mandates that importers provide the STN allocated to their products once their marketing application has been submitted to the FDA. The STN is a unique identifier that tracks a product through the FDA’s regulatory pipeline, from application submission to the final decision on its marketing status.

By requiring the STN at the point of import, the FDA and the CBP can more efficiently cross-reference products against their database to ensure they meet regulatory requirements. This step could reduce delays in the import process and provide a more straightforward path for products that are compliant with FDA standards.

The rule could also enhance accountability and transparency. Importers will need to ensure that their products are not only registered with the FDA but are also traceable through the entire regulatory review process.

Potential headaches and how to avoid them

This requirement is not without its challenges. For importers, it adds another layer of bureaucracy to an already complex process. They must ensure that every product has an STN and that it is accurately submitted to the CBP’s system. Any errors in the process could lead to significant delays, fines or even refusal of entry for their products.

The proposed rule represents a significant shift in how ENDS products will be processed at US points of entry. While the potential for streamlining the admissibility review process is promising, the true test will lie in its implementation. Industry players should stay informed and participate in the ongoing discussions to ensure that the rule benefits the market as intended without imposing undue burdens on importers.

In June this year, the FDA launched a new task force to tackle this issue, in partnership with the Department of Justice and several other agencies – including the US Postal Service, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the Federal Trade Commission – to crack down on the sale of illicit e-cigarettes, including disposables, across the country.

– Antonia Di Lorenzo ECigIntelligence staff

Photo: 4snoopie