§101.65. Implied nutrient content claims and related label statements.

Claims about the food or an ingredient therein that suggest that a nutrient or an ingredient is absent or present in a certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with paragraph (a) of this section.

The phrases “contains the same amount of [nutrient] as a [food]” and “as much [nutrient] as a [food]” may be used on the label or in the labeling of foods, provided that the amount of the nutrient in the reference food is enough to qualify that food as a “good source” of that nutrient, and the labeled food, on a per serving basis, is an equivalent, good source of that nutrient (e.g., “as much fiber as an apple,” “Contains the same amount of Vitamin C as an 8 oz glass of orange juice.”).

Claims may be made that a food contains or is made with an ingredient that is known to contain a particular nutrient, or is prepared in a way that affects the content of a particular nutrient in the food, if the finished food is either “low” in or a “good source” of the nutrient that is associated with the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ______), that level of the nutrient must be present in the food. For example, a claim that a food contains oat bran is a claim that it is a good source of dietary fiber; that a food is made only with vegetable oil is a claim that it is low in saturated fat; and that a food contains no oil is a claim that it is fat free.

This paragraph covers labeling claims that are implied nutrient content claims because they suggest that a food may help consumers maintain healthy dietary practices due to its nutrient content, where there is also implied or explicit information about the nutrition content of the food.

For purposes of this section, a “food group equivalent” identifies qualifying amounts of foods from each food group based on nutritional content. A food group equivalent is equal to the following:

You may use the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the criteria of one or more of the following paragraphs (d)(3)(i) through (vi) of this section as follows:

Each manufacturer of a food (other than foods where the standard information required on the food label, such as the list of ingredients, provides sufficient information to verify that the food meets the food group equivalent requirements to bear the claim, and foods described in paragraphs (d)(3)(i) and (vi) of this section) that bears the implied nutrient content claim “healthy” must make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify that the food meets the food group equivalent requirements of paragraph (d)(2) of this section. These records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request, during an inspection, for official review and photocopying or other means of reproduction. Records may be kept either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records that must be kept in accordance with part 11 of this chapter. These records must be accurate, indelible, and legible.