in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”).
A claim that suggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices when the claim is made with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams of fat”).
4.7.2 Express versus Implied Claims
“Expressed” claims directly characterize the nature of a food; for example, “low fat” and “fat free.” “Implied” claims indirectly characterize the nature of the food by inference or association, rather than by direct statement; for example, “baked, not fried” implies the food is lower in fat than an equivalent fried version. The context and the entire label are often necessary to determine if there is an implied claim.
Implied claims are prohibited when they wrongfully imply that a food contains or does not contain a meaningful level of a nutrient. For example, a product claiming to be made with an ingredient known to be a source of fiber (such as “made with oat bran”) is not allowed unless the product contains enough of that ingredient to meet the definition for “good source” of fiber. As another example, a claim that a product contains “no tropical oils” is allowed—but only on foods that are “low” in saturated fat because consumers have come to equate tropical oils with high saturated fat.
4.7.3 Core Nutrient Level Descriptors
The FDA regulations set conditions for the use of terms that characterize a food’s nutrient level. The general principles on nutrient level descriptors are established in 21 C.F.R. 101.13.65 A claim about the level of a nutrient in a food in relation to the DV is permitted only if the claim uses one of the terms defined by FDA and in accordance with the definition for that term and the general requirements for nutrient content claims.66
The FDA‐defined core nutrient level descriptors are the following:
Free
Good source
Healthy
High
Lean and extra lean
Less and fewer
Light
Low
More
Reduced
These terms are the core nutrient level descriptors. The accepted synonyms and summary definitions of these descriptors follow, but one should always consult the language in Code of Federal Regulations.
Free: Product contains no amount of, or only trivial or “physiologically inconsequential” amounts of, one or more of these components: fat, saturated fat, cholesterol, sodium, sugars, and calories. For example, “calorie‐free” means fewer than 5 calories per serving, and “sugar‐free” and “fat‐free” both mean less than 0.5 grams per serving. Accepted synonyms for “free” include “without,” “no,” and “zero.” A synonym for fat‐free milk is “skim.”
Good source. One serving of the food contains at least 10 percent of the DV for a particular nutrient.67 The terms “contains” and “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.
If it is a meal‐type product, such as frozen entrées and multi‐course frozen dinners, it must provide 10 percent of two or three of these vitamins or minerals or of protein or fiber, in addition to meeting the other criteria.72 The sodium content cannot exceed 480 mg per serving for individual foods and 600 mg per serving for meal‐type products.73
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
