FDA Confirms GRAS Determination of MarinolTM
CHANNAHON, Ill., November 11, 2002 -- Loders Croklaan Lipid Nutrition, a global leader in lipid-based health ingredients, announced that the FDA confirmed GRAS determination of MarinolTM C-38, an Omega-3 fatty acid product.
The Department of Health and Human Services of the FDA contacted Lipid Nutrition regarding GRAS Notice No. GRN 000105 to inform the company that, based on the information provided by Lipid Nutrition, as well as other information available to the FDA, the agency has no questions at this time regarding Lipid Nutrition¡¦s conclusion that MarinolTM C-38 is GRAS under the intended conditions of use. MarinolTM C-38 is intended for use in wet sauce & wet soup applications, salad dressings and milk. As a major ingredient in the MarinolTM Powder, it also can be utilized in breads, biscuits, and other bakery applications where it can be dry blended with other ingredients.
"This notice is a positive step in the direction toward getting MarinolTM C-38 and MarinolTM Powder approved for their intended use in foods by the FDA,"said David R. Lewis, Business Unit Manager, North America, for Loders Croklaan Lipid Nutrition.
"We expect the U.S. market to adopt these uses plus expand into many new areas such as fruit beverages, dairy drinks, margarine and dairy spreads, cereals, breads, and even ice cream."
MarinolTM brand products contain high and effective concentrations of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the omega-3 fatty acids that are known to be responsible for providing health benefits such as brain health and cardiovascular promotion.
Loders Croklaan Lipid Nutrition is a global leader in the supply of scientifically sound lipid ingredients from natural origin, which improve and maintain health and well-being. The company offers a variety of branded products, including ClarinolTM CLA, for weight management.
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