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Once again, we have achieved success and helped our client PMTA successfully obtain STN approval, opening a new chapter in compliance in the US market!
Author.
LCS
Source:
Post time:
2025-03-24
Analysis of PMTA Regulatory Background
The Family Smoking Prevention and Tobacco Control Act of the United States grants the FDA the authority to regulate tobacco products, allowing it to approve or reject applications for risk modified tobacco products.
On May 10, 2016, the FDA issued a final ruling rule (81FR 28973) extending its tobacco product management authority to all products except for those considered accessories of de emed tobacco products. At this point, all new tobacco products (including electronic cigarettes) must submit a PMTA (Tobacco Product Pre Market Application) before being marketed, and can only be sold after FDA review (mainly tobacco product center CTP) approval.
Core objective: To demonstrate through the information submitted to the FDA in PMTA that allowing new tobacco products to be marketed is appropriate for protecting public health (APPH).
Enforcement Update: Starting from 2024, the FDA and Customs (CBP) will conduct strict inspections on products without STN numbers. Non compliant products will face customs interception, market bans, and high penalties.
Why is PMTA important?
As the world's most stringent electronic cigarette access standard, the PMTA audit of the US FDA requires multidimensional tests such as material integrity review, toxicology research, and market impact assessment. According to data from the US Department of Health and Human Services (HHS), as of January 2025, only 34 products worldwide have been granted Marketing Approved Orders (MGOs).
The FDA requires all electronic cigarette companies to submit PMTAs and complete a triple review of toxicology studies, long-term health impact data, and adolescent anti addiction programs. Those who fail will be banned from sale.
PMTA is the only legal way for electronic cigarettes to enter the US market, and it is also a reflection of the company's technological strength and compliance capabilities.
Products through PMTA can be legally sold for a long time, forming a competitive barrier.
The FDA's review standards are referenced by multiple countries, and once approved by PMTA, they can provide endorsement for compliance in other markets.
Core breakthrough: Our company assisted customers in submitting electronic cigarette products that officially obtained STN codes issued by the FDA and successfully passed the PMTA material integrity review. This code is the "passport" for the product to enter the US market, which means that it has broken through the core review process of customs law enforcement. This time, assisting the customer to obtain the STN number again is a comprehensive reflection of our company's product compliance strength.
The strategic value of STN
STN refers to the Submission Tracking Number, which is a unique identification code assigned by the FDA after accepting PMTA applications.
Admission certificate: The US Customs requires electronic cigarette products to provide STN codes during customs clearance, otherwise there is a risk of seizure. Products holding STN can be legally sold during the FDA review period, buying time for companies to seize the market;
Starting point of review: marks the completion of preliminary material review by FDA and enters the substantive review stage of toxicology research, market impact, etc;
Compliance endorsement: STN code is a necessary threshold for participating in market competition. Holding an STN number can significantly reduce the risks of customs seizure, channel delisting, and legal litigation.
Brand trust: STN is an officially recognized compliance label by the FDA, which can enhance the trust between consumers and distributors.
Industry insight
The FDA is currently cracking down on products that have not submitted PMTA, and has detained billions of dollars in illegal electronic cigarettes. Holding STN code will become the core moat to deal with censorship!
Laboratory capability
Technology Navigation: Based on 21 years of experience in the testing field, Lixun Testing provides a full chain service from product testing, toxicology analysis to rectification plans;
Compliance assurance: Strictly comply with FDA's PMTA material standards, including comprehensive data support such as component analysis, environmental assessment, and market research.
Future outlook: We will continue to deepen cooperation with global customers, help more enterprises overcome international certification difficulties, and work together to create a new blue ocean for the electronic cigarette industry!
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