Submission Tracking Number

A Submission Tracking Number or STN is becoming a critical part of successfully importing tobacco products, such as vape devices. An STN can serve as proof that a tobacco product is currently pending review by the Food and Drug Administration’s Center for Tobacco Products. Tobacco products imported or offered for import into the United States must comply with all the applicable requirements of the FDA’s laws and regulations.

A submission tracking number for a tobacco product typically refers to a unique identifier assigned to a specific submission made to the U.S. Food and Drug Administration (FDA) as part of the premarket review process for tobacco products. When a manufacturer or distributor submits an application or notification to the FDA regarding a tobacco product, it is assigned a tracking number to facilitate the tracking and processing of the submission.

The specific format or naming convention of the submission tracking number may vary, but it generally serves as a reference number that allows the FDA and the applicant to track the status and progress of the submission throughout the review process.

An STN is assigned to every premarket submission submitted to CTP, e.g., PMTA. The assignment of the STN can vary from a couple of days to a few weeks. In order to obtain an STN, a company must file a complete PMTA application to the FDA– filing an incomplete submission could result in a quick refusal.

A company’s failure to follow the requirements for importing tobacco products like vape devices could result in the manufacturer, the importer, and/or the brand being listed on FDA’s Red List also known as an Import Alert (Import Alert 98-06).

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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