FDA Issues Final Rule on Omega-3 Fatty Acid Nutrient Content Claims
On April 28, the Food and Drug Administration ("FDA") finalized its rule prohibiting certain claims about omega-3 fatty acids on the labels of foods and dietary supplements. FDA says certain nutrient content claims about omega-3 fatty acids interfere with the public's ability to comprehend the nutritional value of the product in violation of the Federal Food, Drug & Cosmetics Act ("FDCA"). FDA proposed the rule in 2007 after several seafood and fish oil producers notified FDA of their intention to make claims about omega-3 fatty acids in their products. The final rule, which adopts the proposed rule without substantive changes, requires compliance by January 1, 2016.
Nutrient content claims characterize the amount of a nutrient present in a food or dietary supplement. The FDCA allows nutrient content claims, such as "high in," only when FDA has established a reference level for the nutrient. According to the final rule, all nutrient content claims stating that a product is "high in" DHA (docosahexaenoic acid) or EPA (eicosapentaenoic acid) will be prohibited. Similar claims, such as "rich in" and "excellent source of," are also not allowed for EPA and DHA. According to FDA, the reference values proposed in the notifications did not pass muster, primarily because the industry proposals did not identify a single reference value for either omega-3 fatty acid.
The rule also prohibits some, but not all, nutrient content claims for another omega-3 fatty acid, ALA (alpha-linolenic acid). Claims based on 1.6 grams of ALA per day as an adequate intake level are allowed under the rule. For example, a product containing greater than 320 milligrams of ALA (per portion customarily consumed) may bear a label stating that the product is "high in ALA" because it has more than 20 percent of the reference amount of 1.6 grams. Claims based on other reference amounts of ALA are prohibited.
The rule affects a wide variety of products labeled with omega-3 fatty acid claims. These products include, but not are not limited to, seafood, fat-based spreads, eggs, cooking oils, nutritional bars, milk, and meats from grass-fed animals. Product labels may need to be altered to remove claims that do not comply with the rule. Structure/function claims, comparative percentage claims, and truthful, factual statements about the amount of EPA and DHA present in a food (e.g., "Contains x mg of EPA and DHA omega-3 fatty acids per serving") are still allowed, as are qualified health claims about the relationship between EPA and DHA and reduced risk for coronary heart disease.
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Colleen M. Heisey
Emily K. Strunk
Brigid C. DeCoursey, an associate in the Washington Office, assisted in the preparation of this Alert.
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