View all text of Subpart D [§ 101.54 - § 101.69]
§ 101.65 - Implied nutrient content claims and related label statements.
(a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food if:
(1) The claim uses one of the terms described in this section in accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13, with the exception of § 101.13(h) when the nutrient content claim is made in accordance with paragraph (d) of this section; and
(3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable.
(b) Label statements that are not implied claims. Certain label statements about the nature of a product are not nutrient content claims unless such statements are made in a context that would make them an implied claim under § 101.13(b)(2). The following types of label statements are generally not implied nutrient content claims and, as such, are not subject to the requirements of § 101.13 and this section:
(1) A claim that a specific ingredient or food component is absent from a product, provided that the purpose of such claim is to facilitate avoidance of the substances because of food allergies (see § 105.62 of this chapter), food intolerance, religious beliefs, or dietary practices such as vegetarianism or other nonnutrition related reason, e.g., “100 percent milk free;”
(2) A claim about a substance that is nonnutritive or that does not have a nutritive function, e.g., “contains no preservatives,” “no artificial colors;”
(3) A claim about the presence of an ingredient that is perceived to add value to the product, e.g., “made with real butter,” “made with whole fruit,” or “contains honey,” except that claims about the presence of ingredients other than vitamins or minerals or that are represented as a source of vitamins and minerals are not allowed on labels or in labeling of dietary supplements of vitamins and minerals that are not in conventional food form.
(4) A statement of identity for a food in which an ingredient constitutes essentially 100 percent of a food (e.g., “corn oil,” “oat bran,” “dietary supplement of vitamin C 60 mg tablet”).
(5) A statement of identity that names as a characterizing ingredient, an ingredient associated with a nutrient benefit (e.g., “corn oil margarine,” “oat bran muffins,” or “whole wheat bagels”), unless such claim is made in a context in which label or labeling statements, symbols, vignettes, or other forms of communication suggest that a nutrient is absent or present in a certain amount; and
(6) A label statement made in compliance with a specific provision of part 105 of this chapter, solely to note that a food has special dietary usefulness relative to a physical, physiological, pathological, or other condition, where the claim identifies the special diet of which the food is intended to be a part.
(c) Particular implied nutrient content claims. (1) 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.
(2) 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.”).
(3) 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.
(d) General nutritional claims. (1) 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.
(2) 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:
Table 1 to Paragraph
| Food group | Food group equivalent | Examples | (i) Vegetable | 1/2 cup equivalent vegetable | 1/2 cup cooked green beans; 1 cup raw spinach | (ii) Fruit | 1/2 cup equivalent fruit | 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins | (iii) Grains | 3/4 oz equivalent whole grain | 1 slice of bread; 1/2 cup cooked brown rice | (iv) Dairy | 2/3 cup equivalent dairy | 2/3 cup fat free milk; 1 oz nonfat cheese | (v) Protein foods | 1 1/2 oz equivalent game meat | 1 1/2 oz venison | 1 oz equivalent seafood | 1 oz tuna | 1 oz equivalent egg | 1 large egg | 1 oz equivalent beans, peas, or lentils | 1/4 cup black beans | 1 oz equivalent nuts, seeds, or soy products | 1/2 oz walnuts |
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(3) 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:
(i) An individual food or mixed product that is comprised of one or more of the following foods that are the foundation of a healthy dietary pattern, with no other added ingredients except for water:
(A) Vegetable;
(B) Fruit;
(C) Whole grains;
(D) Fat-free or low-fat dairy;
(E) Lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds.
(ii) Individual foods.
(A) An individual food that has a reference amount customarily consumed (RACC) greater than 50 g or greater than 3 tablespoons and meets the conditions per RACC in table 2 of this section; or
Table 2 to Paragraph
| If the food is . . . | It must contain at least . . . | The added sugars content must be no greater than . . . | The sodium content must be no greater than . . . | The saturated fat content must be no greater than . . . | Main category | Sub-category
(if applicable) | ( | 1/2 cup equivalent vegetable | 2% DV | 10% DV | 5% DV. | ( | 1/2 cup equivalent fruit | 2% DV | 10% DV | 5% DV. | ( | 3/4 oz equivalent whole grain | 10% DV | 10% DV | 5% DV. | ( | 2/3 cup equivalent dairy | 5% DV | 10% DV | 10% DV. | ( | 1 1/2 oz equivalent | 2% DV | 10% DV | 10% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV, excluding saturated fat inherent in seafood. | 1 oz equivalent | 2% DV | 10% DV | 10% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans. | ( | 0% DV | 0% DV | 20% of total fat. | 0% DV | 10% DV | 20% of total fat. | 2% DV | 10% DV | 20% of total fat. |
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(B) An individual food that has a RACC of 50 g or less or 3 tablespoons or less and meets the conditions per 50 g of food in table 3 of this section:
Table 3 to Paragraph
| If the food is . . . | It must contain at least . . . | The added sugars content must be no greater than . . . | The sodium content must be no greater than . . . | The saturated fat content must be no greater than . . . | Main category | Sub-category
(if applicable) | ( | 1/2 cup equivalent vegetable | 2% DV | 10% DV | 5% DV. | ( | 1/2 cup equivalent fruit | 2% DV | 10% DV | 5% DV. | ( | 3/4 oz equivalent whole grain | 10% DV | 10% DV | 5% DV. | ( | 2/3 cup equivalent dairy | 5% DV | 10% DV | 10% DV. | ( | 1 1/2 oz equivalent | 2% DV | 10% DV | 10% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV, excluding saturated fat inherent in seafood. | 1 oz equivalent | 2% DV | 10% DV | 10% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV. | 1 oz equivalent | 2% DV | 10% DV | 5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans. | ( | 0% DV | 0% DV | 20% of total fat. | 0% DV | 10% DV | 20% of total fat. | 2% DV | 10% DV | 20% of total fat. |
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(iii) A mixed product that meets the following conditions per RACC:
Table 4 to Paragraphs
| If the mixed product contains at least . . . | The added sugars content must be
no greater than . . . | The sodium content
must be no greater than . . . | Excluding saturated fat inherent in
seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . . | One total food group equivalent with no less than 1/4 food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section | 10% DV | 15% DV | 10% DV. |
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(iv) A main dish product as defined in § 101.13(m) that meets the following conditions per labeled serving:
Table 5 to Paragraph
| If the main dish product contains at least . . . | The added sugars content must be no greater than . . . | The sodium content
must be no greater than . . . | Excluding the saturated fat inherent in
seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . . | Two total food group equivalents with no less than 1/2 food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section | 15% DV | 20% DV | 15% DV. |
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(v) A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving:
Table 6 to Paragraph
| If the meal product contains at least . . . | The added sugars content must be no
greater than . . . | The sodium content
must be no greater than . . . | Excluding the saturated fat inherent in
seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . . | Three total food group equivalents with no less than 1/2 food group equivalent from at least three food groups, as specified in paragraph (d)(2) of this section | 20% DV | 30% DV | 20% DV. |
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(vi) All water, tea, and coffee with less than 5 calories per RACC and per labeled serving.
(4) 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.