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Healthy Choices Based on FDA Definitions

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Dr. Sheldon Margen is professor of public health at UC Berkeley; Dale A. Ogar is managing editor of the UC Berkeley Wellness Letter. They are the authors of several books, including "The Wellness Encyclopedia of Food and Nutrition."

In 1993, the U.S. Food and Drug Administration instituted a set of labeling laws for packaged foods that were designed to help American consumers make healthy choices about food. The nutrition labels, with which we are all now familiar, put nutrients in the context of a 2,000-calorie diet, standardized serving sizes, gave more information on fat, carbohydrate and fiber content and approved the following definitions for words commonly used on labels.

* “Free”: The food must be either absolutely free of a given nutrient (such as fat, sodium or cholesterol) or have an insignificant amount per serving.

* “Fresh”: The food must be raw, never frozen or heated, and contain no preservatives.

* “Fortified,” “enriched,” “added” or “more”: The food must have at least 10% more of the Daily Value for a particular nutrient (dietary fiber, potassium, protein, or an essential vitamin or mineral) that was not originally in the food or was present in smaller amounts.

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* “Healthy”: This term can be used only if a food is low in fat and saturated fat and a serving does not contain more than 480 milligrams of sodium or more than 60 milligrams of cholesterol.

* “High” and “good source”: “High” must equal 20% or more of the Daily Value for that nutrient in a serving. “Rich” or “excellent source” mean the same thing as “high.” “Good source” means a serving contains 10% to 19% of the Daily Value for that nutrient.

* “Lean” and “extra lean”: Used to describe the fat content of meat, poultry, seafood and game, lean foods have fewer than 10 grams of fat, 4 grams of saturated fat and 95 milligrams of cholesterol per serving. “Extra lean” means a food has fewer than 5 grams of fat and fewer than 2 grams of saturated fat.

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* “Light” or “lite”: This term refers to nutritionally altered food products. They must contain one-third fewer calories or one-half the fat of the food from which they were derived. “Light in sodium” can mean that the sodium content of a low-calorie, low-fat food has been reduced by 50%. “Light” can also refer to taste, color and texture--as long as this is explained.

* “Low”: This definition can refer to total fat, saturated fat, cholesterol, sodium and calories. It means you can have a large amount of a food without exceeding the Daily Value for the “low” nutrient. Some terms that mean the same thing are “little,” “few,” “low source of” and “contains a small amount.” “Very low” can be used only on products that have fewer than 35 milligrams of sodium per serving.

* “Reduced” or “less”: This involves a comparison of total fat, saturated fat, cholesterol, sugar, sodium and total calories. A food must have 25% less of a nutrient or calories than the regular product.

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Specific health claims can only be made on food labels in those cases where there is sufficient scientific agreement among qualified experts that the claims are factual and truthful. The food must meet the definitions above for the nutrient in question and the claims must include the terms “may” or “might” to describe the risk-reducing or health-promoting qualities of that food’s nutrients.

Health claims differ from structure / function claims such as “calcium builds strong bones,” which do not deal with disease risk reduction. In the case of structure / function claims, the FDA does not intervene, but the manufacturer is responsible for making sure that such claims are not misleading. By contrast, health claims show a relationship between a nutrient or other substances in food and a disease or health-related condition. They may be used on conventional foods or dietary supplements.

The following links between food and health have been firmly established and are approved for use on food labels:

* Calcium and osteoporosis: The food or supplement must be “high” in calcium and not contain more phosphorus than calcium.

* Sodium and high blood pressure: Foods must meet criteria for “low sodium.”

* Dietary fat and cancer: Foods must meet criteria for “low fat.” Fish and game meats must meet requirements for “extra lean.”

* Dietary saturated fat and cholesterol and coronary artery disease: Foods must meet criteria for “low saturated fat,” “low cholesterol” and “low fat.” Fish and game meats must meet criteria for “extra lean.”

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* Fiber (whole grains, fruits and vegetables) and cancer: Foods must meet requirements for “low fat” and be a “good source” without fortification.

* Fiber (whole grains, fruits and vegetables) and coronary artery disease: Foods must meet criteria for “low saturated fat,” “low fat” and “low cholesterol.” They must contain, without fortification, at least 0.6 grams of soluble fiber per serving.

* Fruits and vegetables and cancer: Foods must meet criteria for “low fat” and, without fortification, be a “good source” of fiber, vitamin A or vitamin C.

* Folate and neural tube birth defects: Foods must meet or exceed criteria for “good source of folate”--that is, at least 40 mcg of folic acid per serving (at least 10% of the Daily Value). A serving of food cannot contain more than 100% of the Daily Value for vitamin A and vitamin D because of their potential risk to fetuses.

* Dietary sugar alcohol and cavities (regular sugar and starches may promote tooth decay, sugarless gum and candies do not): Foods must meet the criteria for “sugar free.” The sugar substitute must be one of several specific sugar alcohols or a combination of them.

The FDA, which receives a lot of criticism for the laborious and time-consuming nature of its approval process, is trying to speed up the turnaround time and expects to have more approved health claims for food producers in the near future. The FDA sees this as a way to give consumers solid information about health-related issues and specifically about the products they buy. It’s possible that paying attention to this information will make your next trip to the supermarket just a little less confusing.

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