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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims February 2016

Final
Docket Number:
FDA-2016-N-0585
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

In the Federal Register of April 28, 2014 (79 FR 23262), the Food and Drug Administration (FDA or we) issued a final rule entitled “Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids” (“the rule”).

The rule prohibits certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

We issued the rule in response to three notifications submitted to us. One notification concerning nutrient content claims for Alpha-Linolenic Acid (ALA), Docosahexaenoic Acid (DHA), and Eicosapentaenoic Acid (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 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. We did not take regulatory action 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 (79 FR 23262).

This rule is effective January 1, 2016.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule, and is intended to assist small entities in complying with the rule (21 CFR 101.8). The rule is binding and has the full force and effect of law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” refers to individuals and entities making nutrient content claims that are subject to the rule.

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If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-N-0585.