News

FDA Finalizes Rule Limiting Permissible Omega-3 FDAMA Nutrient Content Claims

30 April 2014

The ability to make nutrient content claims for omega-3 fatty acids in foods was significantly curtailed by a recently issued final regulation by the Food and Drug Administration (FDA). The rule finalizes a 2007 proposal by FDA regarding nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) submitted by several manufacturers under the procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The rule prohibits nutrient content claims regarding DHA, EPA, and ALA contained in a notification by several seafood processors (Seafood Processors); claims for DHA in a notification by Martek Biosciences Corp. (Martek); and claims regarding DHA and EPA in a notification by Ocean Nutrition Canada, Ltd. (Ocean Nutrition); while allowing the continued use of a nutrient content claim for ALA contained in Martek’s notification. The rule will take effect on January 1, 2016. The rule provides specific guidance on what omega-3 claims FDA deems appropriate as well as how FDA interprets key language in FDAMA.

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Authored by Steve Steinborn and Brian Eyink.