Food companies can now make certain claims about the heart-healthy benefits of omega-3 fatty acids on their packages, the Food and Drug Administration said Wednesday.
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The decision by federal regulators not only provides what is effectively an additional endorsement of these so-called "healthy fats," but will allow consumers to more easily identify brand-name products that contain them.
"FDA has concluded that while these particular fatty acids are not essential to the diet they may be beneficial in reducing coronary heart disease," said FDA acting commissioner Lester Crawford.
While the agency limited the claims to two omega-3 acids known as EPA and DHA, these two fatty acids are frequently touted for their potential health benefits. A third fatty acid found in some leafy vegetables and vegetable-based oils, alpha-linoleic acid, was not included.
Qualified health claims
The agency said it determined there was enough scientific evidence to allow companies to make what are known as qualified health claims, which can be included on food labels based on a preponderance of research results and usually refer to a specific health benefit. The new claims can be used immediately.
In the case of these omega-3s, the FDA will allow claims that discuss heart health. The claim will allow language on packages along these lines: "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease," in addition to listing the content, by serving, of EPA and DHA in a particular food.
Earlier this month, one study also pinpointed DHA as potentially helpful in reducing the effects of Alzheimer's and similar diseases.
These omega-3 acids are found in many oily fish, including salmon, tuna, trout and herring, as well as some wild game and grass-fed meat, and in some enhanced eggs.
But packaged-foods companies have increasingly been looking to supplement products such as breakfast cereal with the omega-3s, which have also been available for years in supplement form.
"Telling a story about your product being good for health versus defending yourself against all those trans fats and carbohydrates is something they're anxious to do," says Tim Ramey, a food analyst with investment firm D.A. Davidson & Co.
Among the companies that lobbied the FDA in favor of the claim was Kraft, which indicated its interest in the claims on salad dressings and mayonnaise.
Companies cannot make the claims if their foods exceed 13 grams of total fat or 60 mg of cholesterol per serving, the FDA said.
No more than 3 grams a day from food
In announcing the new claim, the agency suggested that Americans limit their intake of the two fatty acids to no more than 3 grams a day from food, or 2 grams from a supplement. It did not endorse any particular method or food as most beneficial in providing them.
"We're not trying to compare a supplement versus conventional food," said Barbara Schneeman, who directs the nutritional products and labeling office at the FDA's Center for Food Safety and Applied Nutrition.
Research suggests that as little as 250 to 500 mg per day of these fats may be effective, said Dr. Dariush Mozaffarian, a heart researcher at Brigham and Women's Hospital and Harvard Medical School who has studied the benefits of fatty fish.
Mozaffarian noted it would be difficult to consume the FDA's suggested limit merely by eating seafood. "That's a huge amount of fish," he said.
A major petitioner for the claim was Martek Biosciences Corporation, which manufactures a form of DHA made from algae, and markets it as a way to get the health benefits of omega-3 acids without eating fish. Companies like Martek may benefit as food manufacturers seek out ingredients that allow them to incorporate the fatty acids into new products.
Based on evidence that the long-chain omega-3 acids — DHA and EPA — can help children's eye and brain growth, baby formula supplemented with the omega-3s has surged in popularity during the past two years. Kid-friendly products like yogurt may be targeted for the supplements, and Kellogg's has reportedly tested an omega-3 cereal.
In 2000, the FDA approved a similar claim about dietary supplements containing omega-3s, saying they could help reduce the risk of heart disease, which remains the leading cause of death in the United States. Nearly 1 million Americans die of heart disease and related ailments each year.
Wednesday's announcement marked the second time the agency has approved a qualified claim for food since it began considering them last year. In March, the agency said companies could put language on their labels indicating that walnuts helped reduce the risk of heart disease for people controlling their intake of saturated fats and cholesterol.
Previously, health claims for food required far more detailed research before the FDA approved their use on food labels. The qualified claims were designed as a way to shorten the process and more quickly provide consumers with information on potential health benefits, though some critics believe the review process should be more thorough.
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