Skoka 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.
The application spans 11 varieties and five nicotine strengths.
Skoka has committed approximately $15 million to its regulatory program, including three pharmacokinetic studies and a scientific package addressing areas such as stability, toxicology, actual use, and label comprehension.
The company said the $21.5 million raised to date has funded regulatory preparation, manufacturing expansion, and team growth.
Additional financing is expected to support commercialization.
Skoka intends to begin U.S. retail distribution in 2027 if it reaches the appropriate FDA regulatory milestones.
The products remain subject to FDA review and marketing authorization.
Founder and CEO Dan Aziz spent approximately two and a half years developing the company’s formulation, flavor system, and supporting scientific materials rather than licensing an existing white-label product.
The company said its formulas contain nine proprietary ingredients and are covered by two patent applications relating to the ingredients and blending methods.
Manufacturing is conducted in U.S. FDA-registered facilities using globally sourced ingredients.
Skoka’s investors include more than a dozen professional athletes who invested in their personal capacities, rather than through sponsorship agreements.
Named investors include Darren Throop, PSG Equity founder Mark Hastings, golfer Anthony Kim, former hockey player Sam Gagner, Beau Allen, Jack Eichel, Dylan Larkin, and Scottie Upshall.
Aziz previously founded supplement company Premama, which was acquired by Dr. Reddy’s Laboratories in 2023.
KEY QUOTES:
“We built this company science first. We developed a differentiated base formula using ingredients not traditionally found in nicotine pouches, and then we invested in a comprehensive bundled PMTA before going to market.”
Dan Aziz, Founder And CEO Of Skoka
“I wanted a nicotine pouch that used plant-based sweeteners and couldn’t find one. Adults who use pouches every day want to know what’s in them and who’s standing behind them.”
Dan Aziz, Founder And CEO Of Skoka
