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Fatty Acid Follow-Up: Food Law

FDA issues guidance to help food companies comply with final rule for omega-3 fatty acid claims.

  • In April 2014, FDA published a final rule prohibiting certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids:  docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); and alpha-linolenic acid (ALA).  In short, the rule eliminated a number of proposed nutrient content claims for DHA, EPA, and ALA, but FDA agreed that it would not take action against certain nutrient content claims for ALA.  The rule became effective on January 1, 2016 (which was the uniform compliance date for all labeling regulations that FDA issued between January 1, 2013 and December 31, 2014).

  • FDA has now issued a Small Entity Compliance Guide to help food companies comply with the final rule.  The guidance restates the requirements of the rule using plain language and a Q&A format.  It clearly indicates which types of nutrient content claims for DHA and EPA are prohibited by the rule, and which claims for ALA remain permissible, namely “High,” “Good Source,” and “More” claims.

  • The food industry has had some time to adjust to these changes in the landscape for omega-3 fatty acid claims, but the new user-friendly guidance document still may serve as a helpful resource to companies seeking guidance in this area.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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