[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR101.65] [Page 112-114] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 101_FOOD LABELING--Table of Contents Subpart D_Specific Requirements for Nutrient Content Claims Sec. 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 Sec. 101.13; and (3) The food for which the claim is made is labeled in accordance with Sec. 101.9, Sec. 101.10, or Sec. 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 Sec. 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 Sec. 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 Sec. 105.62 of this chapter), food intolerance, religious beliefs, or dietary practices such as vegetarianism or [[Page 113]] 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: (i) Suggest that a food because of its nutrient content may help consumers maintain healthy dietary practices; and (ii) Are made in connection with an explicit or implicit claim or statement about a nutrient (e.g., ``healthy, contains 3 grams of fat''). (2) You may use the term ``healthy'' or related terms (e.g., ``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: (i) The food meets the following conditions for fat, saturated fat, cholesterol, and other nutrients: [[Page 114]] ------------------------------------------------------------------------ The The If the food The fat saturated cholesterol The food is... level must fat level level must must be... must be... be... contain... ------------------------------------------------------------------------ (A) A raw fruit Low fat as Low The N/A or vegetable defined in saturated disclosure Sec. fat as level for 101.62(b)( defined in cholesterol 2) Sec. specified in 101.62(c)(2 Sec. ) 101.13(h) or less ------------------------------------------------------------------------ (B) A single- Low fat as Low The N/A ingredient or a defined in saturated disclosure mixture of Sec. fat as level for frozen or 101.62(b)( defined in cholesterol canned fruits 2) Sec. specified in and 101.62(c)(2 Sec. vegetables\1\ ) 101.13(h) or less ------------------------------------------------------------------------ (C) An enriched Low fat as Low The N/A cereal-grain defined in saturated disclosure product that Sec. fat as level for conforms to a 101.62(b)( defined in cholesterol standard of 2) Sec. specified in identity in 101.62(c)(2 Sec. part 136, 137 ) 101.13(h) or or 139 of this less chapter ------------------------------------------------------------------------ (D) A raw, Less than 5 Less than 2 Less than 95 At least 10 single- grams (g) g saturated mg percent of ingredient total fat fat per RA cholesterol the RDI\3\ seafood or game per RA\2\ and per 100 per RA and or the meat and per g per 100 g DRV\4\ per 100 g RA of one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber ------------------------------------------------------------------------ (E) A meal Low fat as Low 90 mg or less At least 10 product as defined in saturated cholesterol percent of defined in Sec. Sec. fat as per LS\5\ the RDI or 101.13(l) or 101.62(b)( defined in DRV per LS a main dish 3) Sec. of two product as 101.62(c)(3 nutrients defined in Sec. ) (for a main 101.13(m) dish product) or of three nutrients (for a meal product) of: vitamin A, vitamin C, calcium, iron, protein, or fiber ------------------------------------------------------------------------ (F) A food not Low fat as Low The At least 10 specifically defined in saturated disclosure percent of listed in this Sec. fat as level for the RDI or table 101.62(b)( defined in cholesterol the DRV per 2) Sec. specified in RA of one 101.62(c)(2 Sec. or more of ) 101.13(h) or vitamin A, less vitamin C, calcium, iron, protein or fiber ------------------------------------------------------------------------ \1\ May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable. \2\ RA means Reference Amount Customarily Consumed per Eating Occasion (Sec. 101.12(b)). \3\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)). \4\ DRV means Daily Reference Value (Sec. 101.9(c)(9)). \5\ LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (Sec. 101.9(b)). (ii) The food meets the following conditions for sodium: ------------------------------------------------------------------------ If the food is... The sodium level must be... ------------------------------------------------------------------------ (A) A food with a RA that is 480 mg or less sodium per RA and greater than 30 g or 2 tablespoons per LS (tbsp.) ------------------------------------------------------------------------ (B) A food with a RA that is equal 480 mg or less sodium per 50 g\1\ to or less than 30 g or 2 tbsp. ------------------------------------------------------------------------ (C) A meal product as defined in 600 mg or less sodium per LS Sec. 101.13(l) or a main dish product as defined in Sec. 101.13(m) ------------------------------------------------------------------------ \1\ For dehydrated food that is typically reconstituted with water or a liquid that contains insignificant amounts per RA of all nutrients (as defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared'' form of the product. (iii) The food complies with the definition and declaration requirements in this part 101 for any specific nutrient content claim on the label or in labeling, and (iv) If you add a nutrient to the food specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foods in Sec. 104.20 of this chapter. [58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59 FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, 1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, Mar. 25, 1998; 70 FR 56848, Sept. 29, 2005] [[Page 115]]