GUIDE TO THE FORMAT OF PROPOSED FDA 4 CLAIM LEVELS

Transcription

1 GUIDE TO THE FORMAT OF PROPOSED FDA 4 CLAIM LEVELS 1 Product Component Disease Orange Juice Calcium Osteoporosis Pasta Sauce Lycopene (20 mg) Certain cancers, including prostate cancer in men Breakfast Cereal Trilinium (single claim) Diabetes Fiber (dual claim) Heart Disease Selenium (dual claim) Cancer 4-Levels of Type of Claim A B* C D** (w/o may) [Component] reduces the (w/ may) [Component] may reduce the Point- [Component] may reduce the [Component] may reduce the risk [Component] may reduce the Counterpoint risk of [disease], The scientific evidence is However, the scientific evidence but the scientific evidence is Embedded Language 1 Language 2 Dual Claim Report Card Fiber may reduce the risk of heart disease (A report card graphic) Promising but not conclusive New scientific evidence suggests, but does not prove, that [component] may reduce the A growing body of scientific [Component] may reduce the is limited and not conclusive. Limited and inconclusive scientific risk Limited preliminary studies suggest, but does not prove, that risk Selenium may reduce the risk of cancer (C report card graphic) very limited and preliminary. Very limited and preliminary Emerging yet inconclusive FDA concludes there is little evidence supporting this claim. [Component] may reduce the FDA evaluated the scientific evidence and gave it a [Letter] rating, based on a scale [Component] may reduce the INCLUDING CHECK BOX GRAPHIC ON [Letter] (claim inside the box) Note: Control is a starburst only with a declarative statement such as High in [component]. Tested against all products. * B not tested on Pasta Sauce. ** D not tested on Orange Juice FDA Graphic

2 nutrient content Four Claim Levels: Orange Juice Level* (w/o may): Calcium reduces the risk of osteoporosis. A (w/may): Calcium may reduce the risk of osteoporosis. and gave it an A rating, based on a scale FDA Graphic: Calcium may reduce the risk of osteoporosis. (Check box on A ) B and gave it a B rating, based on a scale FDA Graphic: Calcium may reduce the risk of osteoporosis. (Check box on B ) Embedded: Promising but not conclusive calcium may reduce the risk of osteoporosis. Point-Counterpoint: Calcium may reduce the risk of osteoporosis. The scientific evidence is Language 1: New scientific evidence suggests, but does not prove, that calcium may reduce the risk of osteoporosis. Language 2: A growing body of scientific calcium may reduce the risk of osteoporosis. C and gave it a C rating, based on a scale FDA Graphic: Calcium may reduce the risk of osteoporosis. (Check box on C ) Embedded: Limited and inconclusive scientific calcium may reduce the risk of osteoporosis. Point-Counterpoint: Calcium may reduce the risk of osteoporosis. However, the scientific evidence is limited and not conclusive. Language: Limited preliminary studies suggest, but does not prove, that calcium may reduce the risk of osteoporosis. * D claims not tested on this product. 2 Structure-Function Claim: Calcium helps promote bone health. B1 Language claim

3 nutrient content Four Levels: Pasta Sauce Level* (w/o may): The antioxidant lycopene reduces the risk of certain cancers, including A prostate cancer in men. (w/may): The antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men. cancer in men. FDA evaluated the scientific evidence and gave it an A rating, based on a scale prostate cancer in men. (Check box on A ) C cancer in men. FDA evaluated the scientific evidence and gave it a C rating, based on a scale prostate cancer in men. (Check box on C ) Embedded: Limited and inconclusive scientific the antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men. Point-Counterpoint: Lycopene may reduce the risk of certain cancers, including prostate cancer in men. However, the scientific evidence is limited and not conclusive. Language: Limited preliminary studies suggest, but does not prove, that the antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men. D cancer in men. FDA evaluated the scientific evidence and gave it a D rating, based on a scale prostate cancer in men. (Check box on D ) Embedded: Very limited and preliminary the antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men. Point-Counterpoint: The antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men, but the scientific evidence is very limited and preliminary. Language: Emerging yet inconclusive the antioxidant lycopene may reduce the risk of certain cancers, including prostate cancer in men. * B not tested on this product. 3 Structure-Function Claim: Lycopene helps maintain prostate health. A level Report Card Language

4 nutrient content FDA Graphic Four Claim Levels: Breakfast Cereal Level A B C D (w/o may): Trilinium reduces the risk of diabetes. (w/may): Trilinium may reduce the risk of diabetes. gave it an A rating, based on a scale FDA Graphic: Trilinium may reduce the risk of diabetes. (Check box on A ) gave it a B rating, based on a scale FDA Graphic: Trilinium may reduce the risk of diabetes. (Check box on B ) Embedded: Promising but not conclusive trilinium may reduce the risk of diabetes. Point-Counterpoint: Trilinium may reduce the risk of diabetes. The scientific evidence is Language 1: New scientific evidence suggests, but does not prove, that trilinium may reduce the risk of diabetes. Language 2: A growing body of scientific trilinium may reduce the risk of diabetes. Report Card: Trilinium reduces the risk of osteoporosis. FDA evaluated the scientific evidence and gave it a C rating, based on a scale FDA Graphic Trilinium may reduce the risk of diabetes. (Check box on C ) Embedded: Limited and inconclusive scientific trilinium may reduce the risk of diabetes. Point-Counterpoint: Trilinium may reduce the risk of diabetes. However, the scientific evidence is limited and not conclusive. Language: Limited preliminary studies suggest, but does not prove, that trilinium may reduce the risk of diabetes. gave it a D rating, based on a scale FDA Graphic: Trilinium may reduce the risk of diabetes. (Check box on D ) Embedded: Very limited and preliminary trilinium may reduce the risk of diabetes. Point-Counterpoint: Trilinium may reduce the risk of diabetes, but the scientific evidence is very limited and preliminary. Language: Emerging yet inconclusive trilinium may reduce the risk of diabetes. Structure-Function Claim: Trilinium helps maintain a healthy blood sugar level. 4

5 Guide to the Format of Guidance Statements 5 ORANGE JUICE YOGURT TUNA Guidance Guidance Guidance (w/ product) Claim Claim (w/ product) Eat five fruits and vegetables a day for good health. Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases. Diets rich in fruits and vegetables, including orange juice, may reduce the risk of some types of cancer and other chronic diseases. Eating a diet low in fat and rich in fruits and vegetables may reduce the risk of some types of cancer. Orange juice is high in vitamin C. Vitamin C-rich fruits and vegetables, including orange juice, may reduce the risk of some types of cancer. Eat three servings of dairy foods a day for good bone health. Diets rich in dairy foods may reduce the risk of osteoporosis. Diets rich in dairy foods, including yogurt, may reduce the risk of osteoporosis. A healthy diet with enough calcium may reduce the risk of osteoporosis. Calcium-rich foods, including yogurt, may reduce the risk of osteoporosis. Eat two servings of fish per week for good heart health. Diets rich in fish may reduce the risk of heart disease. Diets rich in fish, including tuna, may reduce the risk of heart disease. Eating a diet low in fat and rich in omega-3 fatty acids may reduce the risk of heart disease. Omega-3 fatty acid-rich foods, including tuna, may reduce the risk of heart disease.