The U.S. Food and Drug Administration (FDA) has announced a final rule prohibiting statements on food product labels, including dietary supplements, that claim products  are “high in,”“rich in,” or an “excellent source of” docosahexaenoic acid (DHA) or eicosapentaenoic  acid (EPA) as well as similar claims for alpha-linolenic acid (ALA). The rule finalizes a proposed  rule the agency published in 2007 without any substantive changes.

Under the U.S. Federal Food, Drug, and Cosmetic Act (the Act), nutrient- content claims such as  “high in” are allowed only for nutrients for which a reference level for the claim has been set,  or, in some situations, if the requirements of the Act have been met, such nutrient levels can be based on authoritative  statements published by certain types of scientific bodies, such as the Institute of Medicine of  the National Academies (IOM).

FDA apparently received notifications in 2004 and 2005 asserting that IOM had issued authoritative  statements that identified such nutrient levels for DHA, EPA and ALA. The agency reports, however,  that multiple notifications identified multiple, and sometimes conflicting, nutrient levels for the  omega-3 fatty acids, leading FDA to determine that none of the claims met the Act’s requirements.

Stakeholder comments on the agency’s analysis of the proposed rule’s impact suggested that hundreds  of product categories, including seafood, yogurt, cheese, meat, eggs, milk, juice, bread, and baby  food would be affected by  the rule and labeling changes would be costly and place an unfair burden on small businesses. Allowing for a transition period, FDA noted that the rule will take effect  January 1, 2016, and manufacturers will have up to one year to comply and change food and  supplement labels accordingly. See CFSAN Constituent Update, April 25, 2014.