Neal D. Fortin

Food Regulation


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“provides” are accepted synonyms for “good source.”

       Healthy. A food that is low in fat and saturated fat and contains limited amounts of cholesterol and sodium.68 In addition, most single‐item foods must provide at least 10 percent of one or more of vitamins A or C, iron, calcium, protein, or fiber. Exempt from this “10‐percent” rule are certain raw, canned, and frozen fruits and vegetables and certain cereal‐grain products.69 These foods can be labeled “healthy,” if they do not contain ingredients that change the nutritional profile, and, in the case of enriched grain products, conform to standards of identity, which calls for certain required ingredients. The food must also comply with the fortification policy for foods (see Section 4.79).70

       Public health recommendations for various nutrients have evolved, as reflected by the updated Nutrition Facts label. Vitamin A and C are no longer nutrients of public health concern, while now potassium, vitamin D, iron, and calcium are. In addition, the type of fat rather than the total amount of fat consumed and the amount of added sugars in the diet are also a concern. While FDA is considering revision of the definition of “healthy,” FDA is exercising enforcement discretion for foods that use the implied nutrient content claim “healthy” on their labels which71:

      1 are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

      2 contain at least ten percent of the DV per reference amount customarily consumed (RACC) of potassium or vitamin D.

       High. The food contains 20 percent or more of the DV74 for a particular nutrient in one serving.75 The terms “rich in” and “excellent source of” are accepted synonyms for “high.”76

       Lean and extra lean. These terms can be used to describe the fat content of meat, poultry, seafood, and game meats.77

       Lean: Less than 10 grams fat, 4.5 grams or less saturated fat, and less than 95 mg cholesterol per serving and per 100 grams.

       Extra lean: Less than 5 grams fat, less than 2 grams saturated fat, and less than 95 mg cholesterol per serving and per 100 grams.

       Low: Foods that can be eaten frequently without exceeding dietary guidelines for one or more of these components: fat, saturated fat, cholesterol, sodium, and calories.

       Low‐fat: 3 grams or less per serving78

       Low‐saturated fat: 1 grams or less per serving

       Low‐sodium: 140 mg or less per serving79

       Very low sodium: 35 mg or less per serving

       Low‐cholesterol: 20 mg or less and 2 grams or less of saturated fat per serving80

       Low‐calorie: 40 calories or less per serving.81

       Synonyms for low include “little,” “few,” “low source of,” and “contains a small amount of.”

       Less. Food, whether altered or not, that contains 25 percent less of a nutrient or of calories than the reference food. For example, pretzels that have 25 percent less fat than potato chips could carry a “less” claim. “Fewer” is an acceptable synonym.

       Light. Either of two meanings: (i) A nutritionally altered product containing at least one‐third fewer calories or at least half the fat of the reference food (if the food derives 50 percent or more of its calories from fat, the reduction must be 50 percent of the fat.); or (ii) the sodium content of a low‐calorie, low‐fat food has been reduced by 50 percent.

       “Light in sodium” may be used on food in which the sodium content has been reduced by at least 50 percent.

       The term “light” still can be used to describe such properties as texture and color, as long as the label explains the intent—for example, “light brown sugar” and “light and fluffy.”

       More. A serving of food, whether altered or not, that contains a nutrient that is at least 10 percent of the DV more than the reference food. The 10 percent of DV also applies to “fortified,” “enriched,” “added,” “extra,” and “plus” claims, but in those cases, the food must be altered. Alternative spelling of these descriptive terms and their synonyms is allowed—for example, “hi” and “lo”—as long as the alternatives are not misleading.82

       Percent fat free: A low‐fat or a fat‐free product, where the claim accurately reflects the amount of fat present in 100 grams of the food. Thus, if a food contains 2.5 grams fat per 50 grams, the claim must be “95 percent fat free.”

       Reduced. A nutritionally altered product that contains at least 25 percent less of a nutrient or of calories than the regular, or reference, product. However, a reduced claim cannot be made on a product if its reference food already meets the requirement for a “low” claim.

       In addition to the core nutrient level descriptors, there are a number of aspects about nutrient content claim that bear special mention.

       Relative Claims83

      A relative claim is a statement that compares the level of a nutrient in the food with the level of a nutrient in a reference food. Relative claims include “light,” “reduced,” “less” (or “fewer” for calories), and “more” claims. The key to making proper relative claims about the level of a nutrient is that the amount of that nutrient in the food must be compared to an amount of nutrient in an appropriate reference food. The reference food varies based on the type of claim being made.

      For “light,” “reduced,” “added,” “extra,” “plus,” “fortified,” and “enriched” claims, the reference food must be a similar food (e.g., potato chips as a reference for potato chips, one brand of multivitamin for another brand of multivitamin). For “light” claims, the reference food must be representative of the type of food that bears the claim. The reference food does not have to be a specific product but can be an average representative of a broad base of foods of that type (e.g., a value in a representative, valid