“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.”

Olive-oil containing products would have to add the following sentence: “One serving of this product contains (x) grams of olive oil.”

We’ve listed some points to remember when using the claim. The first section is for olive oil and the second is for products containing olive oil.

Olive Oil

· The wording must be exactly as stated above.

· The claim must be in a type size no larger than two times the statement of identity and “shall not be unduly prominent in type style compared to the statement of identity.”

· The disclaimer “See nutrition information for saturated fat content” must be placed immediately adjacent to the claim with no intervening material and in the same contrast as the claim itself.

Products Containing Olive Oil

· The wording must be exactly as stated above.

· The claim must be in a type size no larger than two times the statement of identity and “shall not be unduly prominent in type style compared to the statement of identity.”

· Foods eligible to bear the claim are limited to olive oil and certain olive oil products, specifically vegetable oil spread, dressings for salads, shortenings, and olive oil-containing foods. For purposes of enforcement discretion, the following definitions of these conventional foods apply: (1) “olive oil” means products that are essentially pure olive oil and are labeled as such; (2) “vegetable oil spread” means margarine (see generally 21 C.F.R. §166.110) and margarine-like products, formulated to contain olive oil; (3) “dressings for salads” means dressings for salads formulated to contain olive oil; (4) “shortenings” means vegetable oil shortenings, formulated to contain olive oil; and (5) “olive oil-containing foods” means all other foods, such as sauces or baked goods, formulated to contain olive oil.

· The claim is not available for use in labeling main dish products and meal products (see generally 21 C.F.R. §101.13(l)-(m)), nor is it applicable to dietary supplements.

· Olive oil and olive oil products need not qualify as “low fat” (see generally 21 C.F.R. §101.62(b)(2)).

· Olive oil products need not qualify as “low saturated fat” (see generally 21 C.F.R. §101.62(c)(2)). However, foods bearing the claim, including foods that are not “low saturated fat,” should place the following statement immediately adjacent to the claim with no intervening material and in the same contrast as the claim itself: “See nutrition information for saturated fat content.”

· Olive oil and olive oil products need not have a total fat content below the disqualifying level otherwise generally applicable to health claims (see generally 21 C.F.R. §101.14(a)(4)). However, vegetable oil spreads, dressings for salads, shortenings, and olive oil-containing foods that exceed the total fat disqualifying level should bear the following disclosure statement (provided for in 21 C.F.R. §101.13(h)) immediately adjacent to and directly beneath the QHC, with no intervening material, in the same size, typeface, and contrast as the QHC itself: “See nutrition information for total fat content.”

· Olive oil, vegetable oil spreads, and shortenings should not exceed the saturated fat disqualifying level per RACC, but may exceed it per 50 g (see generally 21 C.F.R. §101.14(a)(4)). Dressings for salad should not exceed the saturated fat disqualifying level per RACC or per 50g (see generally 21 C.F.R. §101.14(a)(4)). Olive oil-containing foods should not exceed the saturated fat disqualifying level (see generally 21 C.F.R. § 101.14(a)(4)).

· Olive oil and olive oil products should qualify “low cholesterol” (see generally 21 C.F.R. §101.62(d)(2)). Thus, such foods also should not exceed the cholesterol disqualifying level (see generally 21 C.F.R. §101.14(a)(4)).

· Olive oil and olive oil products should not exceed the sodium disqualifying level (see generally 21 C.F.R. §101.14(a)(4)).

· Olive oil, vegetable oil spreads, and shortenings need not contain, prior to any nutrient addition, at least 10% of the Daily Value (DV) for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per RACC (see generally 21 C.F.R. §101.14(e)(6)). However, vegetable oil spreads and olive oil-containing foods should meet this 10% minimum nutrient content requirement.

· FDA indicated it might at some point add a trans fat threshold level, something that would impact olive oil-containing products.