IDFA Opposes Proposed Rule to Restrict Omega-3 Nutrient Content Claims

In comments filed last week with the Food and Drug Administration (FDA), IDFA opposed a proposed rule that would restrict the use of nutrient content claims for foods containing certain types of omega-3 fatty acids. Because the claims currently in use are based on Daily Values and backed by scientific data from authoritative sources, IDFA urges FDA to allow processors to continue using them.

Dairy products aren't a natural source of omega-3 fatty acids, but some processors are fortifying milk, cheese and yogurt products with the acids to increase the natural nutrient package already present in dairy foods. Under the proposed rule, processors now using these claims for products fortified with two types of omega-3 fatty acids would be required to change their labels.

"The claims provide useful information to consumers about the omega-3 content of the products they purchase and consume," the comments state. "We believe companies should have the ability to provide truthful information, supported by statements from authoritative bodies, on the labels of their food products."

Omega-3 polyunsaturated fatty acids - docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and alpha-linolenic acid (ALA) - have been found to prevent coronary heart disease and provide additional health benefits. Most omega-3 fortified dairy products contain DHA or EPA or a combination of the two, and processors currently are allowed to make claims regarding all three acids.

According to the proposed rule, FDA plans to allow only products using ALA to make nutrient content claims, such as "good source of ALA." The proposed rule reflects FDA's belief that the information used as the basis for the current omega-3 claims is inconsistent with other claims currently in use.

Not set by FDA regulation, omega-3 nutrient content claims are allowed through a notification process under the FDA Modernization Act. Companies must notify FDA about their intent to use the claim and provide an authoritative statement from a governmental agency, such as the Centers for Disease Control, or from the Institute of Medicine, that supports the claim. If FDA doesn't object to the notification within 120 days, food companies can assume that the claim is allowed for use.

Noting that fortifying products with omega-3 fatty acids is a growing practice in the dairy industry, the comments also ask FDA to consider the economic impact that such a change would have on processors. The cost of new labels and obsolete packaging, as well as possible product reformulations to remove omega-3 fatty acids that would be banned from marketing claims, would be significant.

"If FDA decides to continue rulemaking on omega-3 fatty acid claims, further research should be done to take into account the economic impact on dairy food companies," the comments state.

IDFA worked with its ad hoc working group on nutrition to develop the comments. To read the comments, click here.

For more information, contact Michelle Matto, IDFA assistant director of nutrition and labeling, at mmatto@idfa.org or 202-737-4332.

Posted February 19, 2008