AlaskOmega omega-7 concentrates receive GRAS “no questions” letter from FDA

October 9, 2019
Sebastian Krawiec

Following its own evaluation of the safety and toxicology of AlaskOmega 50% and 70% omega-7 concentrates, the U.S. Food and Drug Administration does not dispute the GRAS status of the ingredient. 

Organic Technologies (Coshocton, OH), maker of AlaskOmega omega-3 and omega-7 concentrates, received a “no questions” letter from FDA regarding the self-affirmed GRAS (generally recognized as safe) status of AlaskOmega 50% and 70% omega-7 concentrates. The ingredient became self-affirmed GRAS after a comprehensive review of the safety, toxicology and proposed usage by an independent scientific panel of experts who unanimously agreed that AlaskOmega omega-7 concentrates are safe for use in foods and beverages. FDA’s “no questions” letter indicates that following its own independent evaluation of the safety and toxicological data, the agency does not dispute the GRAS claim.

Omega-7, or palmitoleic acid (C16: n1), is a monosaturated fat that has a wide range of potential health benefits including heart health, inflammation, metabolic health, satiety, and anti-aging for skin, hair, and nails. GRAS status means AlaskOmega 50% and 70% omega-7 concentrates can be incorporated into food and beverage products without regulatory barriers.

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