FDA Allows Qualified Heart Health Claim for Olive Oil

WASHINGTON--The Food and Drug Administration (FDA) approved a qualified health claim for monounsaturated fat from olive oil and reduced risk of coronary heart disease (CHD). The agency found limited, but not conclusive, evidence that using olive oil in place of more saturated fats may reduce the risk of CHD.

"With this claim, consumers can make more informed decisions about maintaining healthy dietary practices," said Lester M. Crawford, Ph.D., FDA's acting commissioner. "Since CHD is the number one killer of both men and women in the United States, it is a public health priority to make sure consumers have accurate and useful information on reducing their risk."

FDA's decision was in response to a health claim petition filed in August 2003 by the North American Olive Oil Association (NAOOA). Nineteen comments were filed on the petition, with 14 supporting the claim unconditionally and the remainder supporting the claim with appropriate qualifications. In its letter to the association, FDA (www.cfsan.fda.gov) noted the agency will exercise enforcement discretion for the following 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 contains [x] grams of olive oil."

In addition, manufacturers must add a disclaimer adjacent to the claim directing consumers to the nutrition labeling panel for information on total fat content.

Bob Bauer, president of NAOOA (http://naooa.mytradeassociation.org), said the group was pleased with FDA's decision and expects to see relabeled products on the market fairly quickly. "This is good news for the industry and for consumers in general," he said. "It gives credence to what people have known, that olive oil is healthy." Bauer noted NAOOA filed the petition prior to FDA's implementation of the qualification system, and therefore expected to see qualification language similar to what FDA issued.