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FDA Has No Questions about GRAS Notification
Jan. 10, 2013 /PRNewswire-USNewswire/ -- Canola oil is now generally recognized as safe (GRAS) for use as an ingredient in infant formula marketed in
the United States. The U.S. Food and Drug Administration (FDA) recently made public that it has no questions in response to a notice that was filed with the agency for the inclusion of canola oil as a source of fat in term infant formulas. Canola oil can be included at levels up to 31 percent of the total fat blend.
"This is significant as canola oil has not previously been used in infant formula in the U.S. due to the absence of a GRAS submission to do so," says Shaunda Durance-Tod, M.S., R.D., manager of the CanolaInfo program at the Canola Council of
Canada. "Canola oil is still a relative newcomer to the marketplace."
All infant formulas marketed in the U.S. must meet federal nutrient requirements. According to the FDA, formulas must contain the essential fatty acids linoleic acid (LA), an omega-6 fatty acid, and alpha-linolenic acid (ALA), an omega-3 fatty acid, which aid in infant growth and development. Canola oil has among the highest ALA content of all edible oils – 11 percent compared to 8 percent in soybean oil.
The FDA requires that any ingredient added to infant formulas be GRAS for the intended use. It also requires formula manufacturers to make a submission to the FDA in advance of the marketing of a new infant formula. The GRAS notification included a review by an expert panel of published scientific studies with infants fed formula containing canola oil.
"When used in combination with other oils that contain LA, canola oil can be used by infant formula manufacturers to target appropriate levels of LA (8-35% of total fatty acids) and ALA (1.75-4% of total fatty acids) and ensure the fat blend is within the recommended ratio of LA:ALA between 6:1 and 16:1," says the response by the FDA to the GRAS notice.