Health Claims OK'd for Foods with Fatty Acids

FDA says fish, supplements with omega-3 cuts heart disease

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By
HealthDay Reporter

WEDNESDAY, Sept. 8, 2004 (HealthDayNews) -- The U.S. government, citing mounting evidence that fatty acids found in some fish cut the risk of heart disease, said Wednesday that food and supplement makers can make health claims on products containing these substances.

The U.S. Food and Drug Administration, joining a growing chorus that includes the American Heart Association, gave the green light to companies whose products have what are called omega-3 fatty acids.

"We are announcing a qualified health claim for a reduced risk of coronary heart disease on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids," acting FDA commissioner Lester M. Crawford said at a news conference.

This means that manufacturers of foods and supplements that contain omega-3 fatty acids can now add the following to their product labels: "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, the label must include the amount of EPA and DHA in a serving of the product.

"The new qualified health claim for omega-3 fatty acids will empower consumers with more information to help combat this disease and improve their health by identifying foods that contain these important compounds," Crawford said.

FDA research found that while these particular fatty acids are not essential in the diet, they do reduce heart disease, he added.

The health claim is restricted to the benefit omega-3 fatty acids have on reducing heart disease, not for any other benefit they may have, said Barbara Schneeman, the director of the Office of Nutritional Products, Labeling and Dietary Supplements in the FDA's Center for Food Safety and Applied Nutrition.

"We would expect someone who uses it [the claim] on their product to indicate the amount of EPA and DHA in their product," added Kathy Ellwood, the division director of Nutrition Programs and Labeling in the Office of Nutritional Products, Labeling and Dietary Supplements.

"We would expect the claims would be used on fish and seafood products that contain the fatty acids," Schneeman said. "We would expect they would be used on supplements that provide the fatty acids."

These fatty acids are found in fatty fish such as salmon, lake trout, tuna, and herring and also in dietary supplements. Currently, the FDA recommends that consumers limit their intake of omega-3 fatty acids to three grams per day from fish and two grams per day from supplements.

Schneeman said these restrictions are based on the potential dangers of ingesting too much omega-3 fatty acid. The risks include a reduced ability for blood to clot, she said.

Ellwood noted that there are restrictions on using this health claim. "There are disqualifying levels for amounts of saturated fat and cholesterol. They [manufacturers] have to meet certain regulatory requirements before they could make the claim," she said.

Earlier this year, the FDA approved a similar qualified health claim for walnuts, which contain other properties that appear to reduce the risk of heart disease.

More information

The American Heart Association can tell you about the importance of omega-3 fatty acids.

SOURCES: Sept. 8, 2004, news conference with Lester M. Crawford, D.V.M., Ph.D, acting commissioner, U.S. Food and Drug Administration, Rockville, Md.; Barbara Schneeman, Ph.D., director, Office of Nutritional Products, Labeling and Dietary Supplements, FDA Center for Food Safety and Applied Nutrition; Kathy Ellwood, Ph.D, division director, Nutrition Programs and Labeling, Office of Nutritional Products, Labeling and Dietary Supplements, FDA Center for Food Safety and Applied Nutrition

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