On April 28, 2014 the U.S. Food and Drug Administration (FDA) published a final rule (the Rule), prohibiting statements on food product labels and dietary supplement labels that claim products are "high in," "rich in," or an "excellent source of" the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as some such claims for alpha-linolenic acid (ALA). The Rule will affect hundreds of product categories, requiring costly labeling changes that must be made by January 1, 2016, which is the uniform compliance date for food labeling rules issued between January 1, 2013 and December 31, 2014. Product inventory manufactured through December 31, 2015 will not be affected by this new Rule.
"Nutrient content claims" are labeling claims that characterize the level of a nutrient in a food. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), nutrient content claims, such as "high in," are allowed only for nutrients for which a reference level for the claim has been set. FDA has not established nutrient levels that can serve as the basis for nutrient content claims for DHA, EPA, or ALA.
In 2004 and 2005, FDA received three notifications for nutrient content claims for DHA, EPA, and ALA, asserting that the Institute of Medicine of the National Academies (IOM) had issued authoritative statements that identified nutrient reference levels for DHA, EPA, and ALA on which nutrient content claims could be based. These notifications identified multiple, but, in some cases, conflicting, nutrient reference levels of DHA, EPA, and ALA. FDA issued the Rule, in part, because it determined that IOM's statements on DHA and EPA did not establish nutrient levels for those omega-3 fatty acids, and, thus, there was not a sufficient basis for making nutrient content claims. Accordingly, the Rule prohibits all DHA and EPA nutrient content claims. With regard to the two sets of nutrient content claims for ALA that were identified in the notifications, FDA determined that one of the sets of claims, which was based on a population-weighted approach to establish a reference amount customarily consumed (RACC) of ALA, did not meet the requirements of the FD&C Act. Therefore, FDA is only allowing ALA claims that are based on a population-coverage-derived RACC. The nutrient content claims are described in the below charts.
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The broad-ranging product categories of food products which will likely require label changes include, but are not limited to, the following:
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Food manufacturers with products labeled with omega-3 fatty acid claims should begin reviewing their product labels and labeling, including websites and other marketing materials, to assess compliance with the Rule and should arrange for relabeling, if necessary. Retailers will need to work closely with suppliers and contract manufacturers to verify compliance and timelines for any necessary label changes. Products with DHA and/or EPA nutrient content claims in the distribution chain before January 1, 2016 may be sold with the old labels, but FDA encourages manufacturers to use up their labeling inventory between now and the compliance date.