FDA Proposes Rule to Restrict Omega-3 Nutrient Content Claims

The Food and Drug Administration (FDA) last week issued a proposed rule that would restrict the use of nutrient content claims for foods containing certain types of omega-3 fatty acids. Under the proposed rule, dairy processors now using these claims for milk and cheese products fortified with two types of omega-3 fatty acids would be required to change their labels.

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. According to the proposed rule, FDA plans to allow only products using ALA to make nutrient content claims, such as "good source of ALA." FDA based the proposed change on information provided by the National Academy of Sciences' Institute for Medicine, which has determined recommended intake levels for ALA but not for DHA or EPA. Most omega-3 fortified dairy products contain DHA or EPA or a combination of the two.

FDA issued the proposed rule in response to three notifications from food companies in 2004 and 2005. Because FDA had not responded until now, many companies, including several dairy processors, are already legally using the claims.

Omega-3 nutrient content claims are not set by FDA regulation; they 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.

"Notifications are not only for the companies submitting them," said Michelle Matto, IDFA assistant director of nutrition and labeling. "Once the claim is allowed, either by FDA's acceptance or lack of prohibition, any company can use the notification to make the same claim."

Under the proposed rule, processors would not be allowed to use some label claims currently in use, such as "Excellent source of omega-3 EPA and DHA. Contains __ mg of EPA and DHA combined per serving, which is __% of the 160 mg Daily Value for a combination of EPA and DHA." The proposed rule would not affect the ability of companies to use the omega-3 qualified health claim or to make truthful statements about omega-3 content, such as "32mg of DHA omega-3 per serving."

IDFA believes that processors should be able to continue to use these claims and will work with members of the ad hoc working group on nutrition to develop comments. Members also may submit individual comments by the February 11, 2008, deadline. For more information, contact Matto at mmatto@idfa.org or 202-737-4332.

To read the proposed rule, click here.

Posted December 10, 2007