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FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims

May 21, 2014

The U.S. Food and Drug Administration (FDA) is publishing 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), finalizing a proposed rule the agency published in 2007 without substantive changes.

The final rule prohibits statements on the labels of food products, including dietary supplements, 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, however it takes no action with respect to other such claims for ALA.

Under the Federal Food, Drug & Cosmetic Act, nutrient content claims such as “high in” are allowed only for nutrients for which a reference level to which the claim refers has been set. The FDA can set such nutrient levels by regulation, or in some situations, if the requirements of the act have been met.