The US Food and Drug Administration (“FDA”) published in the Federal Register on April 28, 2014 a final rule banning certain nutrient content claims for foods that contain omega-3 fatty acids. Specifically, the agency prohibits statements on food labels and dietary supplement labels that the products are “high in” docosahexaenoic acid (“DHA”) or high in eicosapentaenoic acid (“EPA”). The rule also applies to synonyms of “high in” such as “rich in” or “excellent source of”. Additionally, the agency banned the use of certain statements about alpha-linolenic acid (“ALA”). With regard to ALA, the agency said that claims made by certain seafood processors using words like “high”, “good source” and “more” to describe ALA were prohibited as they were “inherently misleading.” However, the agency said that similar claims for ALA made by another processor could remain on the labels as the final rule would neither prohibit nor modify the nutrient content claims.
Under the Food, Drug, and Cosmetic Act (“FDCA”), nutrient content claims such as “high in” are permitted only for nutrients for which the agency has set a reference level to which the claim will apply. These reference levels are established by regulation or through authoritative statements published by certain scientific bodies, such as the Institute of Medicine, so long as such statements satisfy the requirements of the FDCA. No such reference level has been established for DHA, EPA, or ALA. While the Institute of Medicine had previously issued authoritative statements identifying nutrient levels for DHA, EPA, and ALA, the FDA determined that none of the statements met the requirements of the FDCA because they were based upon an incorrect standard. As a result, the agency issued its final rule to prohibit nutrient content claims for these omega-3 fatty acids. This rule finalizes a proposed rule that FDA published back in 2007 and did not include any substantial changes. The rule will take effect on January 1, 2016 and manufacturers will have up to one year to comply with the rule and change food and supplement labels accordingly.