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 has prohibited 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.

The agency took this action in response to three notifications submitted to it in 2004 and 2005. One notification concerning nutrient content claims for ALA, DHA, and 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.  The agency indicated that it was 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.

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, with regard to the seafood processors’ notification, none of the statements met the requirements of the FDCA because they were based upon an incorrect standard; they used the population-weighted approach, which is a different methodology that would not enable the public to comprehend the information provided in the claim and to understand the relevant significance of such information in the context of the daily diet.  As a result, the agency issued its final rule to prohibit nutrient content claims for these omega-3 fatty acids.  The agency, however, determined that it would not take regulatory action on the ALA claims in the Martek notification because it used a population-coverage approach that is consistent with the approach that the FDA has used to date.  The agency did not express a conclusion as to whether the ALA claims in the Martek notification are supported by an authoritative statement that satisfies the requirements of the FDCA.

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.

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