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Final Rule Prohibits Content Claims for Some Omega-3 Fatty Acids

Apr 30, 2014
The Food and Drug Administration issued on Friday a final rule prohibiting certain nutrient content claims for foods that contain three types of omega-3 fatty acids: docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and alpha-linolenic acid (ALA). This rule finalizes the proposed rule that FDA published in 2007 without any substantive changes. It will become effective January 1, 2016.

Dairy products aren’t a natural source of omega-3 fatty acids, but some processors fortify milk, cheese and yogurt products with the acids to increase the natural nutrient package already present in dairy foods. Under the rule, companies using certain claims for products fortified with DHA, EPA and ALA will be required to change their labels.

The rule specifically prohibits statements on labels that claim the products are "high in" DHA or EPA and bans synonyms such as “rich in” and “excellent source of.” It also prohibits some of these claims for ALA.

The claims under question were originally allowed through notifications to FDA following authoritative statements from independent scientific authorities. According to FDA, the notifications did not set the levels for the claims through approaches consistent with FDA’s existing rules on nutrient content claims.

Conflicting Statements

According to the rule, statements from the Institute of Medicine, previously considered authoritative on nutrient levels for DHA, EPA, and ALA, provided conflicting information and did not meet the requirements of the Act. However, some claims for ALA did meet requirements and will be allowed to continue to be used on product labels. These claims include “excellent source of ALA” claims on products containing 320 mg of ALA per Reference Amount Customarily Consumed (RACC), “good source of ALA” claims on products containing 160 mg or more of ALA per RACC and “more ALA” claims on products with at least 160 mg more of ALA than an appropriate reference food. 

The rule also confirmed that foods and beverages, including dairy products, may use the qualified health claim regarding DHA and EPA omega-3 fatty acids and heart disease on labels of products that meet the requirements set by FDA. The qualified health claim states "supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of the food] provides [X] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content]."

Product labels may also make a statement about the level of DHA and EPA in a product, such as “X mg of EPA and DHA omega-3 fatty acids per serving.” 

The final rule is available here.

Members with questions may contact Michelle Matto, IDFA nutrition and labeling consultant, at or Cary Frye, IDFA vice president of regulatory and scientific affairs, at

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