FDA published a final rule prohibiting certain nutrient content claims for foods that contain the omega-3 fatty acids docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and alpha-linolenic acid (ALA). The final rule prohibits label statements that claim the products are "high in" DHA or EPA, and synonyms such as "rich in" and "excellent source of." The final rule similarly prohibits some such claims for ALA. Under current regulations, content claims such as "high in" are only allowed for nutrients for which a reference level to which the claim refers has been set. FDA has not established nutrient levels that can serve as the basis for nutrient content claims for DHA, EPA or ALA.
Food and Drug Administration
April 28, 2014
The Food and Drug Administration (FDA, the Agency, or we) is issuing this rule to prohibit certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to three notifications submitted to us. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). The final rule prohibits the nutrient content claims for DHA and EPA set forth in the three notifications and the nutrient content claims for ALA set forth in the seafood processors notification. FDA is taking no regulatory action at this time with respect to the nutrient content claims for ALA set forth in the Martek notification and, therefore, these claims will be allowed to remain on the market.