FDA’s Latest Import Alert on Nicotine Pouches: What It Means for Manufacturers

The nicotine pouch market in the US is growing rapidly, but so is regulatory scrutiny. The FDA’s latest import alert (#98-06) illustrates one thing clearly: products without the required marketing authorisation risk detention at the border without physical examination. 

For manufacturers looking to enter or expand in the US market, compliance is not optional. 

Regulatory Challenges: Turning Hurdles into Opportunities 

To market a new tobacco product in the US, you must follow one of the three paths: 

1. Premarket Tobacco Product Applications (PMTA) 

1. Substantial Equivalence (SE) Reports 

1. Exemption from Substantial Equivalence Requests (EX REQ) 

The only pathway via which a new applicant can market a nicotine pouch in the US, is via the PMTA. The FDA requires a Premarket Tobacco Product Application (PMTA) for all new nicotine pouches. Without a PMTA, products may be considered adulterated and misbranded, leading to detentions, import refusals, and market exclusion. 

But with challenge comes opportunity.   The brands that succeed will be those that embrace scientific substantiation and take proactive steps toward compliance. A well-prepared PMTA isn’t just a regulatory requirement, it is the foundation for long-term market success. 

Navigating Compliance with Broughton 

At Broughton, we support companies in navigating the US regulatory landscape with confidence. From toxicology and analytical testing to submission strategy and engagement with the FDA, we provide end-to-end PMTA support. 

Want to ensure your nicotine pouch products remain compliant and stay on the market? Contact our team today.