in paragraph (d) of this section will be amended from time to time to list additional nutrients and/or to change the levels of specific RDI's as improved knowledge about human nutrient requirements and allowances develops. The policy set forth in this section is based on U.S. dietary practices and nutritional needs and may not be applicable 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 scientific community to exist and known to result in nutritional deficiency disease 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 principle.

(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 established in subpart C of this part, and common or usual name regulations established 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 nutrient(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 potassium 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 procedures 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 accordance with any other Federal regulation that permits voluntary nutrient additions.

(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 vitamin, mineral, and protein content if:

(1) A normal serving of the food contains 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 following nutrients per 100 calories based on 2,000 calorie total intake as a daily standard:

regulations established elsewhere in this chapter.

(g) A nutrient added to a food is appropriate only when the nutrient:

(1) Is stable in the food under customary conditions of storage, distribution, 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 excessive intake of the nutrient, considering cumulative amounts from other sources in the diet; and

(4) Is suitable for its intended purpose and is in compliance with applicable provisions of the act and regulations governing the safety of substances 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 (the blank to be filled in with the common or usual name of the food) may be used to describe foods fortified in accordance with the principles established in paragraph (c) of the section.

(2) The labeling claim, "vitamins and minerals (and "protein" when appropriate) added are in proportion to caloric 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 permitted, the term "enriched," "fortified," "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 labeling, other than in a listing of the nutrient ingredients as part of the ingredient 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 derived from meat, poultry, fish, cheese, or eggs.

(2) One or more vegetables or vegetable 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 mixture.

(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, excluding their sauces, gravies, breading, etc., shall provide not less than 70 percent of the total protein supplied by the components named in paragraph (a) of this section.

(c) If it is necessary to add any nutrient(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. Nutrients used for such addition shall be biologically available in the final product. (d) Minimum levels of nutrients for a frozen "heat and serve" dinner are as follows:

(1) A frozen "heat and serve" dinner prepared from conventional food ingredients 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 pantothenic acid, vitamin B-6, and vitamin B-12 are tentative. Final levels will be established when sufficient data are available. Until final levels are established, a product containing less than the tentative levels will not be deemed to be misbranded when labeled in accordance 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 desirable 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 paragraph (a) of this section (e.g., soup, bread or rolls, beverage, or dessert), their contribution shall not be considered in determining compliance with the nutrient levels established in paragraph (d) of this section but shall be included in any nutrition labeling.

Subpart B-Label Statements

Hypoallergenic foods.

105.65 Infant foods.

105.66 Label statements relating to usefulness 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 applicable with the following additions:

(a)(1) The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows:

(i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight;

(ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood;

(iii) Uses for supplementing or fortifying 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

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 nutritive sweetener, shall be considered a use for regulation of the intake of calories 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 regulations 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 represented for special dietary use by reason of the decrease or absence of any allergenic property or by reason of being offered as food suitable as a substitute for another food having an allergenic property, the label shall bear:

(a) The common or usual name and the quantity or proportion of each ingredient (including spices, flavoring, and coloring) in case the food is fabricated 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 ingredient 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 ingredient 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 represented for special dietary use for infants, the label shall bear, if such food is fabricated from two or more ingredients, the common or usual name of each ingredient, including spices, flavoring, 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 animal which is its source, such name shall be so qualified as to reveal clearly 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 maintaining body weight.

(a) General requirements. Any food that purports to be or is represented for special dietary use because of usefulness 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 dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient.

(2) A special dietary food may contain 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 dietary usefulness in reducing or maintaining 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

(c) "Low calorie" foods. A food purporting to be "low calorie" must comply 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 purporting to be "reduced calorie" or otherwise 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," "artificially 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 compliance 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 regulation, to any use of the term "diet" that clearly shows that the food is offered 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 replacement or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation 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

Sec.

Subpart A-General Provisions

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 Formulas

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 reformulations.

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 regulation.

(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 regulations 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 regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.