April 26, 2004 – Halifax, Nova Scotia, Canada-- Ocean Nutrition Canada (ONC) - innovator and supplier of the finest quality marine-based natural ingredients to the global dietary supplements and food markets announced today that their omega-3 powder fish oil ingredient has achieved Generally Recognized As Safe (GRAS) status with the Food and Drug Administration (FDA) in the United States.
ONC’s submission to the FDA summarized conclusions of an expert scientific panel who evaluated dietary exposure, source of the substance, method of manufacture, specifications, contaminant levels, and information from recent published toxicological and human studies. The FDA reviewed and accepted this submission under the stringent GRAS notification system for the intended conditions of use.
The new GRAS status opens opportunities for consumers to obtain the health promoting components of omega-3 fish oil - EPA (Eicosapentaenoic Acid) and DHA (Docosahexaenoic Acid) from foods manufactured with this omega-3 powder ingredient.
Mr. Robert Orr, President of Ocean Nutrition Canada, stated ” Our omega-3 powder food ingredient is a solution for Americans seeking to achieve the daily recommended requirements of up to 650 mg per day of EPA and DHA, currently the average daily consumption of Americans is only 71 mg per day“ Mr. Orr also noted “ There has been a Qualified Health Claim by the FDA for Dietary Supplements which states that Omega-3 fatty acids EPA and DHA support cardiovascular health and now Americans can eat heart healthy foods with our omega-3 powder ingredient .“
Major clinical trials and epidemiological studies have shown that increasing the dietary intake of omega-3 fatty acids, in the form of fish or of fish oil supplements, can have a profound effect upon cardiovascular disease. Even in those people with no evidence of prior cardiovascular disease, blood levels of omega-3 fatty acids are found to be inversely related to the risk of sudden death.
Mr. Ian Lucas, Vice President Marketing commented “ The ONC Omega-3 powder is a major technology breakthrough in healthy food ingredients . It has a very high nutritional density of omega-3 ,which allows consumers to get more omega-3 per serving. The powder also can be cooked in food, such as bread or mixed into liquids like milk , and has no change in the taste or smell of the food product. Consumers will soon be able to improve their cardiovascular health by eating the foods they love to eat”
This accomplishment by ONC of achieving GRAS status with the FDA further proves ONC’s strong commitment to quality, which includes pharmaceutical level cGMP (Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Point) certification of its manufacturing and packaging facilities. ONC also has Canadian Drug Identification Number (DIN) certification for the omega-3 concentrates and is compliant with the Council for Responsible Nutrition (CRN) monograph for long chain omega-3 fatty acids.
About Ocean Nutrition Canada (ONC):
Ocean Nutrition Canada is a privately held company, and wholly owned subsidiary of Clearwater Fine Foods Inc., one of Canada's largest suppliers of quality seafood products. Ocean Nutrition Canada researches, manufactures and markets omega-3 concentrates and other marine based natural ingredients for the dietary supplement and functional food markets. ONC exemplifies scientific rigor in discovery and research programs along with world leading regulatory and quality compliance standards.