Commitment to FDA compliance and U.S. Market Authorisation

As a company rooted in transparency, compliance, and scientific rigor, N.G.P Tobacco ApS has strategically aligned its nicotine pouch portfolio with the regulatory framework established by the U.S. Food and Drug Administration (FDA) under the Premarket Tobacco Product Application (PMTA) pathway. Our nicotine pouch products are currently pre-approved under the FDA’s regulatory process and have received official Submission Tracking Numbers (STNs). These STNs authorize lawful marketing, sales, and distribution in the U.S. while the applications proceed through FDA’s multi-phase review.

As an active participant in this highly regulated process, N.G.P Tobacco has commenced comprehensive analytical testing and clinical studies, underscoring our commitment to producing reduced-risk nicotine products backed by robust scientific evidence. These studies will provide critical data on product constituents, abuse liability, and user health impacts—elements essential for advancing the PMTAs through substantive review.

Our ultimate objective is to achieve full FDA approval, reinforcing N.G.P Tobacco’s long-term dedication to compliance, consumer safety, and responsible innovation in the U.S. marketplace.