The letter indicates the agency has successfully completed its own independent evaluation of AlaskOmega omega-7 concentrates and has no questions regarding Organic Technologies’ conclusion that these ingredients are GRAS under their intended conditions of use.
AlaskOmega 50% and 70% omega-7 concentrates achieved self-affirmed GRAS status through an independent scientific panel of experts that evaluated AlaskOmega omega-7 concentrates in accordance with FDA safety criteria. Following a comprehensive review of the safety, toxicology and proposed usage, the independent panel of experts reached a unanimous decision that AlaskOmega omega-7 concentrates are safe for use in foods and beverages.
Omega-7, or palmitoleic acid (C16:n1), is a monosaturated fat that has been studied for its potential benefits across a wide range of health applications, including heart health, anti-inflammation, insulin sensitivity, satiety, and anti-aging benefits for skin, hair and nails. With the self-affirmed GRAS status, AlaskOmega 50% and 70% omega-7 concentrates can be safely used in food and beverage products without regulatory barriers, expanding application options beyond dietary supplements.
Organic Technologies is currently conducting a clinical trial using AlaskOmega 50% omega-7 concentrate to assess the ingredient’s health benefit towards inflammation, glucose management, satiety, and cholesterol markers.