FDA Releases Small Entity Compliance Guide on Omega-3 Fatty Acids Final Rule

Constituent Update

February 22, 2016

The U.S. Food and Drug Administration is announcing the availability of a Small Entity Compliance Guide (SECG) to help small entities (food companies) comply with FDA’s final rule that addressed specific nutrient content claims for Omega-3 fatty acids. The SECG restates the requirements of the final rule in a plain language question and answer format.

The final rule “Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids,” which was published in the Federal Register on April 28, 2014 and became effective January 1, 2016, prohibits claims that a food is "high in" DHA or EPA. Synonyms such as “rich in” and “excellent source of” DHA or EPA are also prohibited. The final rule also prohibits some such claims for ALA, but takes no action with respect to other such claims for ALA.

The SECG discusses requirements for submitting a notification for a prospective nutrient content claim; types of nutrient content claims prohibited by the rule; why nutrient content claims for DHA and EPA are prohibited by the rule; why nutrient content claims for ALA based on a population-weighted approach are prohibited; and which claims for ALA are allowed to remain on the market at this time.

You may submit electronic or written comments on the SECG at any time starting February 23, 2016.

Submit electronic comments to and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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