Commitment to FDA compliance and U.S. Market Authorization

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 PMTA application acceptance is under the FDA’s regulatory process. Submission Tracking Numbers (STNs) have been received for lawful marketing, sales, and distribution in the U.S. while the application proceeds through the 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.