- Olive Oil Can Claim It Helps Heart, FDA Says
- November 16, 2004
- Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
The Food and Drug Administration announced on November 1, 2004 that marketers can make the qualified health claim that the monounsaturated fat from olive oil can reduce the risk of coronary heart disease (CHD).
The agency said 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.
A qualified health claim on a conventional food must be supported by credible scientific evidence. The FDA's evaluation of this evidence is outlined in its "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements."
Because the evidence is not conclusive, the FDA is limiting olive oil marketers to the following 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 the FDA has announced for conventional food since the process for establishing such claims took effect last year. In separate announcements earlier this year, the FDA said that walnuts and foods such as salmon, lake trout, and tuna containing omega-3 fatty acids, could make a qualified health claim for reduced risk of coronary heart disease.
Additional information about qualified health claims is available online at www.cfsan.fda.gov/~dms/qhcolive.html.
Significance: The FDA's qualified health claim initiative is qualified good news for marketers of conventional foods, although the rate of approval may not be as fast as the industry would like. As the FDA's site reveals, there are many more applications still being processed.