Skoka Inc. said it has raised $21.5 million and submitted a bundled Premarket Tobacco Product Application to the U.S. Food and Drug Administration covering 55 nicotine pouch products across 11 varieties and five strengths. The company submitted the application Oct. 1 and plans to begin U.S. retail distribution in 2027, subject to FDA authorization. Skoka said it has committed $15 million to its regulatory program, including pharmacokinetic studies, toxicology, stability testing, actual-use research, and label-comprehension studies.
Founded in 2024 by Dan Aziz, Skoka developed its own formulations and has filed two patent applications covering ingredients and blending methods. The products are manufactured in the United States using globally sourced ingredients. Investors include executives and professional athletes, who invested in their individual capacities rather than as brand endorsers.