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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-100
November 1, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Allows Qualified Health Claim to Decrease Risk of Coronary Heart Disease

The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for monounsaturated fat from olive oil and reduced risk of coronary heart disease (CHD).

There is limited but not conclusive evidence that suggests that consumers may reduce their risk of CHD if they consume monounsaturated fat from olive oil and olive oil-containing foods in place of foods high in saturated fat, while at the same time not increasing the total number of calories consumed daily.

"With this claim, consumers can make more informed decisions about maintaining healthy dietary practices," said Dr. Lester M. Crawford, Acting FDA Commissioner. "Since CHD is the number one killer of both men and women in the U.S., it is a public health priority to make sure that consumers have accurate and useful information on reducing their risk."

A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, as outlined in FDA's "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements", FDA is announcing the availability of this claim on food labels and the labeling of olive oil and certain foods that contain olive oil.

Although this research is not conclusive, the FDA intends to exercise its enforcement discretion with respect to the following qualified health claim:

Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product [Name of food] contains [x] grams of olive oil."

This claim is the third qualified health claim FDA has announced for conventional food since the process for establishing such claims took effect last year. Additional information about qualified health claims is available online at www.cfsan.fda.gov/~dms/qhcolive.html.

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