FDA scientists thoroughly reviewed information on the identity, method of manufacture, specifications, safety, potential for toxicity and health effects of high-linolenic flaxseed oil. Achieving GRAS status opens the door to the U.S. food industry for HiOmega® high-linolenic flax oil. Polar Foods Inc. intends HiOmega® flaxseed oil for use as replacement for edible oils in various food categories resulting in an estimated dietary intake of less than 22g of HiOmega® high-linolenic flaxseed oil per day (equivalent to 15g of ALA per day).
Peer-reviewed scientific studies have shown that consumption of omega-3 in the form of ALA from flaxseed oil has significant cardiovascular health benefits, including reducing the risk of sudden cardiac death. Additional health benefits include anti-cancer effects and protection of bone, kidney and liver health and maintenance of healthy DHA levels. HiOmega® flax oil has a beneficial balance of omega-6: omega-3 (1:7) and a lower level of saturated fat than fish omega-3 oils. The high omega-3 content of flaxseed oil helps to balance the omega-3:omega-6 ratio of the total diet. HiOmega® flaxoil is the highest vegetable source of omega-3.
FDA GRAS approval offers the opportunity to food manufacturers to place claims on their labels such as “contains Omega-3.” Manufacturers may consider using structure/function claims with HiOmega® high-linolenic flaxoil such as “Rich/high/excellent source of ALA Omega-3” and “Omega-3 fatty acids support overall and cardiovascular health.”
For a copy of the GRAS affirmation see the Polar Foods Inc. website at www.polarfoods.net and click on GRAS or http://www.cfsan.fda.gov/~rdb/opa-g256.html.