Nutritional Quality Guidelines for Foods (21 CFR 104.5-104.47)

179 Food and Drug Administration, HHS § 104.5 Scientific name of crab Common or usual name of crabmeat Chionoecetes opilio, Snow crabmeat. Chionoecetes tanneri, Chionoecetes bairdii, and Chionoecetes angulatus Erimacrus isenbeckii Korean variety crabmeat or Kegani crabmeat. Lithodes aequispina Brown King crabmeat. Paralithodes brevipes King crabmeat or Hanasaki crabmeat. Paralithodes camtschaticus King crabmeat and Paralithodes Platypus. [42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995] § 102.54 Seafood cocktails. The common or usual name of a sea food cocktail in package form fab ricated with one or more seafood ingre dients shall be: (a) When the cocktail contains only one seafood ingredient, the name of the seafood ingredient followed by the word ‘‘cocktail’’ (e.g., shrimp cocktail, crabmeat cocktail) and a statement of the percentage by weight of that sea food ingredient in the product in the manner set forth in § 102.5(b). (b) When the cocktail contains more than one seafood ingredient, the term ‘‘seafood cocktail’’ and a statement of the percentage by weight of each sea food ingredient in the product in the manner set forth in § 102.5(b). § 102.55 Nonstandardized breaded composite shrimp units. (a) The common on usual name of the food product that conforms to the defi nition and standard of identity de scribed by § 161.175(c)(6) of this chapter, except that the food is made from comminuted shrimp and is not in raw frozen form, shall be ‘‘lll made from minced shrimp,’’ the blank to be filled in with the words ‘‘breaded shrimp sticks’’ or ‘‘breaded shrimp cutlets’’ de pending upon the shape of the product, or if prepared in a shape other than that of sticks or cutlets ‘‘breaded shrimp lll made from minced shrimp,’’ the blank to be filled by a word or phrase that accurately de scribes the shape and that is not mis leading. (b) The words ‘‘made from minced shrimp’’ shall immediately follow or appear on a line(s) immediately below the other words required by this sec tion in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives: (1) Not less than one-sixteenth inch in height on packages having a prin cipal display panel with an area of 5 square inches or less and no less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or (2) Not less than one-half the height of the largest type used in the words ‘‘breaded shrimp sticks’’ or the other comparable words required by this sec tion. § 102.57 Greenland turbot (Reinhardtius hippoglossoides). ‘‘Greenland turbot’’ is the common or usual name of the food fish Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye flounders. The term ‘‘halibut’’ may be associated only with Atlantic halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus stenolepis). PART 104—NUTRITIONAL QUALITY GUIDELINES FOR FOODS Subpart A—General Provisions Sec. 104.5 General principles. Subpart B—Fortification Policy 104.20 Statement of purpose. Subpart C—Specific Nutritional Quality Guidelines 104.47 Frozen ‘‘heat and serve’’ dinner. AUTHORITY: 21 U.S.C. 321, 343, 371(a). SOURCE: 42 FR 14327, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food. (b) Labeling for a product which com plies with all of the requirements of VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 180 21 CFR Ch. I (4–1–11 Edition) § 104.20 the nutritional quality guideline estab lished for its class of food may state ‘‘This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Govern ment,’’ except that the words ‘‘this product’’ are optional. This statement, if used, shall be printed on the prin cipal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by § 101.105 of this chapter. Labeling of noncomplying products may not in clude any such statement or otherwise represent, suggest, or imply the prod uct as being, in whole or in part, in compliance with a guideline. (c) A product bearing the statement provided for in paragraph (b) of this section, in addition to meeting the re quirements of the applicable nutri tional quality guideline, shall comply with the following requirements: (1) The label of the product shall bear the common or usual name of the food in accordance with the provisions of the guideline and §§ 101.3 and 102.5(a) of this chapter. (2) The label of the product shall bear nutrition labeling in accordance with §§ 101.2 and 101.9 of this chapter and all other labeling required by applicable sections of part 101 of this chapter. (d) No claim or statement may be made on the label or in labeling rep resenting, suggesting, or implying any nutritional or other differences be tween a product to which nutrient ad dition has or has not been made in order to meet the guideline, except that a nutrient addition shall be de clared in the ingredient statement. (e) Compliance with a nutrient level specified in a nutritional quality guide line shall be determined by the proce dures and requirements established in § 101.9(g) of this chapter. (f) A product within a class of food for which a nutritional quality guide line has been established and to which has been added a discrete nutrient ei ther for which no minimum nutrient level or nutrient range or other allow ance has been established as appro priate in the nutritional quality guide line, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph (b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the fol lowing prominent and conspicuous statement: ‘‘The addition of lll to (or ‘‘The addition of lll at the level contained in) this product has been de termined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food,’’ the blank to be filled in with the common or usual name of the nu trient(s) involved. [42 FR 14327, Mar. 15, 1977, as amended at 63 FR 14818, Mar. 27, 1998] Subpart B—Fortification Policy § 104.20 Statement of purpose. (a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and mainte nance of a desirable level of nutritional quality in the nation’s food supply is an important public health objective. The addition of nutrients to specific foods can be an effective way of main taining and improving the overall nu tritional quality of the food supply. However, random fortification of foods could result in over- or underfortifica tion in consumer diets and create nu trient imbalances in the food supply. It could also result in deceptive or mis leading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it con sider it appropriate to fortify fresh produce; meat, poultry, or fish prod ucts; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to for tify foods are urged to utilize these principles when adding nutrients to food. It is reasonable to anticipate that the Reference Daily Intakes (RDI’s) as delineated in § 101.9 of this chapter and in paragraph (d) of this section will be amended from time to time to list ad ditional nutrients and/or to change the levels of specific RDI’s as improved VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 181 Food and Drug Administration, HHS § 104.20 knowledge about human nutrient re quirements and allowances develops. The policy set forth in this section is based on U.S. dietary practices and nu tritional needs and may not be applica ble in other countries. (b) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to correct a dietary insufficiency recognized by the sci entific community to exist and known to result in nutritional deficiency dis ease if: (1) Sufficient information is available to identify the nutritional problem and the affected population groups, and the food is suitable to act as a vehicle for the added nutrients. Manufacturers contemplating using this principle are urged to contact the Food and Drug Administration before implementing a fortification plan based on this prin ciple. (2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions. (Other Federal regulations include, but are not limited to, standards of identity promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act, nutritional quality guidelines estab lished in subpart C of this part, and common or usual name regulations es tablished in part 102 of this chapter.) (c) A nutrient(s) listed in paragraph (d)(3) of this section may appropriately be added to a food to restore such nu trient(s) to a level(s) representative of the food prior to storage, handling, and processing, when: (1) The nutrient is shown by adequate scientific documentation to have been lost in storage, handling, or processing in a measurable amount equal to at least 2 percent of the Daily Reference Value (DRV) of protein and of potas sium and 2 percent of the Reference Daily Intake (RDI) in a normal serving of the food. (2) Good manufacturing practices and normal storage and handling proce dures cannot prevent the loss of such nutrient(s), (3) All nutrients, including protein, iodine and vitamin D, that are lost in a measurable amount are restored and all ingredients of the food product that contribute nutrients are considered in determining restoration levels; and (4) The food is not the subject of any other Federal regulation that requires or prohibits nutrient addition(s), or the food has not been fortified in accord ance with any other Federal regulation that permits voluntary nutrient addi tions. (d) A nutrient(s) listed in paragraph (d)(3) of this section may be added to a food in proportion to the total caloric content of the food, to balance the vi tamin, mineral, and protein content if: (1) A normal serving of the food con tains at least 40 kilocalories (that is, 2 percent of a daily intake of 2,000 kilocalories); (2) The food is not the subject of any other Federal regulation for a food or class of food that requires, permits, or prohibits nutrient additions; and (3) The food contains all of the fol lowing nutrients per 100 calories based on 2,000 calorie total intake as a daily standard: Nutrient Unit of measurement DRV or RDI 1 Amount per 100 calories Protein .............. grams (g) .................. 50 2 .5 Vitamin A .......... International Unit (IU) 5,000 250 Vitamin C .......... milligrams (mg) ......... 60 3 Calcium ............. g ............................... 1 0 .05 Iron .................... mg ............................ 18 0 .9 Vitamin D .......... IU .............................. 400 20 Vitamin E .......... do ............................. 30 1 .5 Thiamin ............. mg ............................ 1 .5 0 .08 Riboflavin .......... do ............................. 1 .7 0 .09 Niacin ................ do ............................. 20 1 Vitamin B6 ......... do ............................. 2 .0 0 .1 Folate ................ micrograms (μg) ....... 400 20 Vitamin B12 ....... do ............................. 6 .0 0 .3 Biotin ................. mg ............................ 0 .3 0 .015 Pantothenic acid do ............................. 10 0 .5 Phosphorus ....... g ............................... 1 .0 0 .05 Magnesium ....... mg ............................ 400 20 Zinc ................... do ............................. 15 0 .8 Iodine ................ μg ............................. 150 7 .5 Copper .............. mg ............................ 2 .0 0 .1 Potassium ......... do ............................. 3,500 175 1 RDI’s for adults and children 4 or more years of age. (e) A nutrient(s) may appropriately be added to a food that replaces tradi tional food in the diet to avoid nutri tional inferiority in accordance with § 101.3(e)(2) of this chapter. (f) Nutrient(s) may be added to foods as permitted or required by applicable regulations established elsewhere in this chapter. (g) A nutrient added to a food is ap propriate only when the nutrient: VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 182 21 CFR Ch. I (4–1–11 Edition) § 104.47 (1) Is stable in the food under cus tomary conditions of storage, distribu tion, and use; (2) Is physiologically available from the food; (3) Is present at a level at which there is a reasonable assurance that consumption of the food containing the added nutrient will not result in an ex cessive intake of the nutrient, consid ering cumulative amounts from other sources in the diet; and (4) Is suitable for its intended pur pose and is in compliance with applica ble provisions of the act and regula tions governing the safety of sub stances in food. (h) Any claims or statements in the labeling of food about the addition of a vitamin, mineral, or protein to a food shall be made only if the claim or statement is not false or misleading and otherwise complies with the act and any applicable regulations. The following label claims are acceptable: (1) The labeling claim ‘‘fully restored with vitamins and minerals’’ or ‘‘fully restored with vitamins and minerals to the level of unprocessed lll’’ (the blank to be filled in with the common or usual name of the food) may be used to describe foods fortified in accord ance with the principles established in paragraph (c) of the section. (2) The labeling claim, ‘‘vitamins and minerals (and ‘‘protein’’ when appro priate) added are in proportion to ca loric content’’ may be used to describe food fortified in accordance with the principles established in paragraph (d) of this section. (3) When labeling claims are per mitted, the term ‘‘enriched,’’ ‘‘for tified,’’ ‘‘added,’’ or similar terms may be used interchangeably to indicate the addition of one or more vitamins or minerals or protein to a food, unless an applicable Federal regulation requires the use of specific words or statements. (i) It is inappropriate to make any claim or statement on a label or in la beling, other than in a listing of the nutrient ingredients as part of the in gredient statement, that any vitamin, mineral, or protein has been added to a food to which nutrients have been added pursuant to paragraph (e) of this section. [45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993] Subpart C—Specific Nutritional Quality Guidelines § 104.47 Frozen ‘‘heat and serve’’ din ner. (a) A product, for which a common or usual name is established in § 102.26 of this chapter, in order to be eligible to bear the guideline statement set forth at § 104.5(b), shall contain at least the following three components: (1) One or more sources of protein de rived from meat, poultry, fish, cheese, or eggs. (2) One or more vegetables or vege table mixtures other than potatoes, rice, or cereal-based product. (3) Potatoes, rice, or cereal-based product (other than bread or rolls) or another vegetable or vegetable mix ture. (b) The three or more components named in paragraph (a) of this section, including their sauces, gravies, breading, etc.: (1) Shall contribute not less than the minimum levels of nutrients prescribed in paragraph (d) of this section. (2) Shall be selected so that one or more of the listed protein sources of paragraph (a)(1) of this section, exclud ing their sauces, gravies, breading, etc., shall provide not less than 70 per cent of the total protein supplied by the components named in paragraph (a) of this section. (c) If it is necessary to add any nutri ent(s) in order to meet the minimum nutrient levels prescribed in paragraph (d) of this section, the addition of each such nutrient may not result in a total nutrient level exceeding 150 percent of the minimum level prescribed. Nutri ents used for such addition shall be bio logically available in the final product. (d) Minimum levels of nutrients for a frozen ‘‘heat and serve’’ dinner are as follows: VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00192 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 183 Food and Drug Administration, HHS § 105.3 Nutrient Minimum levels for fro zen ‘‘heat and serve’’ dinner— For each 100 Cal ories (keal) of the total compo nents specified in par. (a) For the total com ponents specified in par. (a) Protein, grams ............................... 4.60 16.0 Vitamin A, IU ................................. 150.00 520.0 Thiamine, mg ................................. .05 .2 Riboflavin, mg ................................ .06 .2 Niacin, mg ..................................... .99 3.4 Pantothenic acid, mg ..................... .32 1.1 Vitamin, B6, mg ............................. .15 .5 Vitamin, B1 ..................................... .33 1.1 Iron, mg ......................................... .62 2.2 (1) A frozen ‘‘heat and serve’’ dinner prepared from conventional food ingre dients listed in paragraph (a) of this section will also contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels for these nutrients cannot be established at the present time but may be specified as additional data are obtained. (2) The minimum levels for panto thenic acid, vitamin B–6, and vitamin B–12 are tentative. Final levels will be established when sufficient data are available. Until final levels are estab lished, a product containing less than the tentative levels will not be deemed to be misbranded when labeled in ac cordance with § 104.5(b). (3) When technologically practicable, iodized salt shall be used or iodine shall be present at a level equivalent to that which would be present if iodized salt were used in the manufacture of the product. (4) When technologically practicable, product components and ingredients shall be selected to obtain the desir able calcium to phosphorous ratio of 1:1. Technological addition of phosphates shall be minimized and shall not exceed the amount necessary for the intended effect. (e) If the product includes servings of food which are not prescribed by para graph (a) of this section (e.g., soup, bread or rolls, beverage, or dessert), their contribution shall not be consid ered in determining compliance with the nutrient levels established in para graph (d) of this section but shall be in cluded in any nutrition labeling. (f) For the purposes of labeling, an ‘‘average serving’’ shall be one entire frozen ‘‘heat and serve’’ dinner. [42 FR 14327, Mar. 5, 1977] PART 105—FOODS FOR SPECIAL DIETARY USE Subpart A—General Provisions Sec. 105.3 Definitions and interpretations. Subpart B—Label Statements 105.62 Hypoallergenic foods. 105.65 Infant foods. 105.66 Label statements relating to useful ness in reducing or maintaining body weight. Subpart C [Reserved] Subpart D—Standards of Identity [Reserved] AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 350, 371, 379e. SOURCE: 42 FR 14328, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 105.3 Definitions and interpretations. The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter ‘‘the act’’) shall be applica ble with the following additions: (a)(1) The term special dietary uses, as applied to food for man, means par ticular (as distinguished from general) uses of food, as follows: (i) Uses for supplying particular die tary needs which exist by reason of a physical, physiological, pathological or other condition, including but not lim ited to the conditions of diseases, con valescence, pregnancy, lactation, aller gic hypersensitivity to food, under weight, and overweight; (ii) Uses for supplying particular die tary needs which exist by reason of age, including but not limited to the ages of infancy and childhood; (iii) Uses for supplementing or for tifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00193 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R