Foods for special dietary use (21 CFR 105.3-105.66)

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 184 21 CFR Ch. I (4–1–11 Edition) § 105.62 of whether such food also purports to be or is represented for general use. (2) The use of an artificial sweetener in a food, except when specifically and solely used for achieving a physical characteristic in the food which cannot be achieved with sugar or other nutri tive sweetener, shall be considered a use for regulation of the intake of cal ories and available carbohydrate, or for use in the diets of diabetics and is therefore a special dietary use. (b)–(d) [Reserved] (e) For the purposes of the regula tions in this part, the terms infant, child, and adult mean persons not more than 12 months old, more than 12 months but less than 12 years old, and 12 years or more old, respectively. [42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979; 44 FR 49665, Aug. 24, 1979] Subpart B—Label Statements § 105.62 Hypoallergenic foods. If a food purports to be or is rep resented for special dietary use by rea son of the decrease or absence of any allergenic property or by reason of being offered as food suitable as a sub stitute for another food having an al lergenic property, the label shall bear: (a) The common or usual name and the quantity or proportion of each in gredient (including spices, flavoring, and coloring) in case the food is fab ricated from two or more ingredients. (b) A qualification of the name of the food, or the name of each ingredient thereof in case the food is fabricated from two or more ingredients, to reveal clearly the specific plant or animal that is the source of such food or of such ingredient, if such food or such in gredient consists in whole or in part of plant or animal matter and such name does not reveal clearly the specific plant or animal that is such a source. (c) An informative statement of the nature and effect of any treatment or processing of the food or any ingre dient thereof, if the changed allergenic property results from such treatment or processing. § 105.65 Infant foods. (a) If a food (other than a dietary supplement of vitamins and/or min erals alone) purports to be or is rep resented for special dietary use for in fants, the label shall bear, if such food is fabricated from two or more ingredi ents, the common or usual name of each ingredient, including spices, fla voring, and coloring. (b) If such food, or any ingredient thereof, consists in whole or in part of plant or animal matter and the name of such food or ingredient does not clearly reveal the specific plant or ani mal which is its source, such name shall be so qualified as to reveal clear ly the specific plant or animal that is such source. [42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985] § 105.66 Label statements relating to usefulness in reducing or maintain ing body weight. (a) General requirements. Any food that purports to be or is represented for special dietary use because of use fulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in conformity with § 101.9, or, where applicable, § 101.36 of this chapter, unless exempt under that section; and (2) A conspicuous statement of the basis upon which the food claims to be of special dietary usefulness. (b) Nonnutritive ingredients. (1) Any food subject to paragraph (a) of this section that achieves its special die tary usefulness by use of a nonnutri tive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the per centage by weight of the nonnutritive ingredient. (2) A special dietary food may con tain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the food under the applicable law and regulations of this chapter. Any food that achieves its special die tary usefulness in reducing or main taining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00194 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 185 Food and Drug Administration, HHS § 106.1 nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener, e.g., ‘‘Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).’’ (c) ‘‘Low calorie’’ foods. A food pur porting to be ‘‘low calorie’’ must com ply with the criteria set forth for such foods in § 101.60(b)(2) and (b)(3) of this chapter. (d) ‘‘Reduced calorie’’ foods and other comparative calorie claims. A food pur porting to be ‘‘reduced calorie’’ or oth erwise containing fewer calories than a reference food must comply with the criteria set forth for such food in § 101.60(b)(4) and (b)(5) of this chapter. (e) Label terms suggesting usefulness as low calorie or reduced calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, and in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘ar tificially sweetened,’’ or ‘‘sweetened with nonnutritive sweetener’’ only if the claim is not false and misleading, and the food is labeled ‘‘low calorie’’ or ‘‘reduced calorie’’ or bears another comparative calorie claim in compli ance with part 101 of this chapter and this section. (2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regu lation, to any use of the term ‘‘diet’’ that clearly shows that the food is of fered solely for a dietary use other than regulating body weight, e.g., ‘‘for low-sodium diets.’’ (3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replace ment or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regula tion governing the use of such terms on foods. (f) ‘‘Sugar free,’’ and ‘‘no added sugar.’’ Criteria for the use of the terms ‘‘sugar free’’ and ‘‘no added sugar’’ are provided for in § 101.60(c) of this chapter. [58 FR 2430, Jan. 6, 1993] Subpart C [Reserved] Subpart D—Standards of Identity [Reserved] PART 106—INFANT FORMULA QUALITY CONTROL PROCEDURES Subpart A—General Provisions Sec. 106.1 Status and applicability of the quality control procedures regulation. 106.3 Definitions. Subpart B—Quality Control Procedures for Assuring Nutrient Content of Infant For mulas 106.20 Ingredient control. 106.25 In-process control. 106.30 Finished product evaluation. 106.90 Coding. Subpart C—Records and Reports 106.100 Records. Subpart D—Notification Requirements 106.120 New formulations and reformula tions. AUTHORITY: 21 U.S.C. 321, 350a, 371. SOURCE: 47 FR 17025, Apr. 20, 1982, unless otherwise noted. Subpart A—General Provisions § 106.1 Status and applicability of the quality control procedures regula tion. (a) The criteria set forth in §§ 106.20, 106.25, 106.30, 106.90, and 106.100 shall apply in determining whether an infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the requirements of regula tions promulgated under section 412(a)(2) of the act. (b) The failure to comply with any regulation set forth in §§ 106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the manufacturing, processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1)(C) of the act. (c) References in this part to regu latory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00195 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