April 23, 2025 | Expert Insights
In today’s competitive global market, manufacturers looking to enter the U.S. market must understand the regulatory requirements set forth by the Food and Drug Administration (FDA). The process of bringing a new tobacco or nicotine product to market is complex, involving multiple steps to ensure consumer safety and regulatory compliance. Two critical elements in this process are the Pre-Market Tobacco Application (PMTA) and the Submission Tracking Number (STN). Understanding the connections between these two components is essential for navigating the regulatory landscape and achieving market entry in the U.S, especially for foreign manufacturers.
STN vs. PMTA: Know the Difference
To effectively navigate the regulatory process, manufacturers must first be able to distinguish between the terms “PMTA” and “STN”. While these terms are related, they represent separate but interrelated components of the FDA’s approval process, and understanding their differences is crucial to successfully bringing a product to market.
PMTA: The Path to Marketing Authorization
A PMTA, or Pre-Market Tobacco Application, is a request submitted to the FDA for any new tobacco or nicotine product seeking marketing authorization. Under section 910(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), this application must be submitted before a new product can legally enter the U.S. market. It is important to note that the PMTA applies not only to tobacco-derived nicotine products but also to nicotine derived from any source.
The PMTA process is comprehensive, and the FDA requires substantial scientific evidence to support the safety and efficacy of the product. The applicant must provide detailed documentation on the product’s ingredients, manufacturing processes, certifications, validations, and the potential risks it may pose to public health. The submission of the PMTA will always generate an STN for tracking purposes, but it will only result in a Marketing Granted Order (MGO) if the product demonstrates through this application that the product’s benefits outweigh the risks and is therefore, Appropriate for the Protection of Public Health (APPH).
The key takeaway for manufacturers is that a well-prepared PMTA is essential for obtaining not only an STN but also the Marketing Granted Order (MGO), which authorizes the product for sale. Because of the FDA’s APPH standards, failure to submit a scientifically vigorous and well-documented PMTA will likely result in the rejection of the product, hindering market entry.
STN: Tracking Your Application
The Submission Tracking Number (STN) is a unique number assigned by the FDA to track the submission of a tobacco product application throughout the review process. This number is generated when a PMTA is submitted and serves as an important tool for the FDA to manage the review process.
While the STN is a necessary result of the PMTA submission, it does not guarantee that the product will be authorized for sale. The STN merely signifies that the FDA has received the submission and is reviewing it. It is important for manufacturers to understand that an STN alone is not sufficient to put or keep the product on the market legally. Without a thorough and scientifically supported PMTA, the FDA will not grant manufacturers an MGO, which is required for legal market entry. Enforcement decisions are made case-by-case, considering youth use and other risks.
Import Authorization vs. Market Authorization
Many foreign manufacturers mistakenly believe that obtaining an STN is sufficient to legally market their products in the United States. This misunderstanding often arises from U.S. Customs and Border Protection (CBP) requirements, which include verifying the presence of an STN before allowing nicotine products manufactured outside the U.S. to enter the country. While an STN may facilitate importation, it does not equate to full legal marketing authorization. Products may not be legally marketed in the US until they receive an MGO from the FDA. Ultimately, the decision to take enforcement action against these products lies with the FDA and CBP. Factors influencing this decision include the manufacturer’s compliance history, whether they are repeat violators of FDA regulations, and whether their products pose a high risk to public health or youth access.
Enforcement Risks for Unlawful Product Marketing
It is necessary for manufacturers to understand the serious enforcement consequences associated with marketing and selling products without proper FDA authorization, as the FDA has stringent policies regarding the marketing of new tobacco products. Products that do not follow the correct PMTA process are subject to enforcement actions. Any new tobacco product marketed without FDA authorization can face enforcement, such as warning letters, civil monetary penalties (CMPs), and even injunctions.
1. Warning Letters and Civil Monetary Penalties (CMPs)
The FDA typically begins enforcement actions by issuing a warning letter notifying companies of their unauthorized products. The letter requires a response within 15 working days that outlines corrective actions to be taken by the manufacturer. If the violation is not rectified, the FDA can proceed with further penalties.
The FDA may issue CMPs against manufacturers selling tobacco products without the required marketing authorization. These manufacturers are given 30 days to respond to a CMP, either by paying a penalty, negotiating a settlement, or requesting a hearing. Failure to address CMPs can lead to default orders.
2. Injunctions and Legal Actions
In extreme cases, an injunction may be filed to stop ongoing violations of tobacco product regulations. This legal action through the Department of Justice (DOJ) aims to prevent further violations and ensure compliance with FDA requirements. Manufacturers may settle these injunctions by signing consent decrees, which prevent further violations under specified conditions.
3. Detention at the Border
Customs and Border Protection play a critical role in enforcing tobacco regulations. Products lacking an STN are at risk of being detained at the U.S. border. When an STN is absent, the FDA may place the product on the “Red List,” subjecting it to detention without physical examination (DWPE). This can significantly delay the importation process and lead to additional scrutiny by regulatory agencies. However, if an STN is in place, it demonstrates that the manufacturer is in the process of compliance, which can allow the product to continue being imported while awaiting final approval.
Final Thoughts
In conclusion, understanding the differences between the PMTA and the STN is critical for manufacturers, both domestic and foreign, seeking to enter the U.S. tobacco market. While an STN may seem like sufficient evidence of regulatory compliance, it is only part of the process. To legally market a product, manufacturers must submit a comprehensive PMTA that is scientifically robust and meets all FDA requirements. Without this, products risk severe enforcement action, including fines, detention, and even legal actions.
Austin Tyner
Document Specialist
Austin focuses on client documentation intake, review, and analysis here at Accorto. Austin has worked extensively with clients in the tobacco harm reduction sector, ensuring that all documentation aligns with evolving FDA regulations to ensure application success. Austin’s keen attention to detail and ability to distill complex information into clear, precise documentation is invaluable in ensuring the accuracy and completeness of our regulatory submissions.
With an educational background in English and Comparative Literature from the University of North Carolina at Chapel Hill, Austin brings exceptional writing, editing, and analytical skills to Accorto’s application development team.
