any interested person who has submitted a petition, may issue a proposal to issue, amend, or revoke a regulation prescribing a nutritional quality guideline for a class of foods, pursuant to Part 10 of this chapter.

[42 FR 14327, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]

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 maintenance 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 maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over- or underfortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food. It is reasonable to anticipate that the U.S. RDA'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 additional nutrients and/or to change the levels of specific U.S. RDA'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

and

scientific community to exist 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(s) 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 U.S. RDA (and 2 percent of 2.5 grams of potassium and 4.0 milligrams of manganese, when appropriate) 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 kilocalories based on a 2,000-kilocalorie total intake as a daily standard:

1U.S. Recommended Daily Allowance (U.S. RDA) for adults and children 4 or more years of age.

2 If the protein efficiency ratio of protein is equal to or better than that of casein, the U.S. RDA is 45 g.

3 No U.S. RDA has been established for either potassium or manganese; daily dietary intakes of 2.5 g. and 4.0 mg., respectively, are based on the 1979 Recommended Dietary Allowances of the Food and Nutrition Board, National Academy of Sciences-National Research Council.

(e) A nutrient(s) may appropriately be added to a food that replaces traditional food in the diet to avoid nutritional inferiority in accordance with § 101.3(e)(2) of this chapter.

(f) Nutrient(s) may be added to foods as permitted or required by ap

plicable 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 acceptabie:

(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 in

60-052 0-80--5

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]

Subpart C-Specific Nutritional Quality Guidelines

§ 104.47 Frozen "heat and serve" dinner.

(a) A produci, 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.

(f) For the purposes of labeling, an “average serving” shall be one entire frozen "heat and serve" dinner.

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 usefulness in reducing or maintaining caloric intake or body weight.

105.67 Certain label statements relating to food for use in the diet of diabetics. 105.69 Foods used to regulate sodium intake.

Subpart C-[Reserved]

Subpart D-Standards of Identity—[Reserved]

AUTHORITY: Secs. 403, 701, 52 Stat. 10471048 as amended, 1055-1056 as amended (21 U.S.C. 343, 371), unless otherwise noted. 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 distinguised 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.

(Secs. 201(n), 401, 403 (a) and (j), 411, 701 (a) and (e), 52 Stat. 1041, 1046-1048, 1055, 70 Stat. 919, 90 Stat. 410-411 (21 U.S.C. 321(n), 341, 343 (a) and (j), 350, 371 (a) and (e))) [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.

(Secs. 401, 403(j), 701(e), 52 Stat. 1046 as amended, 1048, 70 Stat. 919 (21 U.S.C. 341, 343(j), 371(e)))

§ 105.65 Infant foods.

(a) If a food (other than a dietary supplement of vitamins and/or minerals 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.

(c) If such use of the food is by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk, the label shall also bear:

(1) A statement of the percent by weight or weight per unit volume of moisture, protein, fat, available carbohydrate, ash, and crude fiber contained in such food.

(2) A statement of the number of available kilocalories (in the case of food label statements, a kilocalorie is represented by the word "Calorie") supplied by a specified quantity of such food as customarily or usually prepared for consumption.

(3) A statement of the amount of each vitamin or mineral listed in paragraph (c)(5) of this section and the amount of other added vitamin(s) and mineral(s) supplied by a specified quantity of such food as customarily or usually prepared for consumption.

(4) The statement "This product should not be used as the sole source of protein in the infant diet" if a quantity which supplies 100 available kilocalories of such food as customarily or usually prepared for consumption contains less than 1.8 grams of protein of a biological quality equivalent to that of casein, or if the amount and biological quality of protein per 100 available kilocalories of such food are such that the quality of protein

expressed as a fraction of that of casein multiplied by the amount of protein in grams is less than 1.8, or if the biological quality of protein is less than 70 percent of that of casein.

(i) For the purpose of this paragraph (c)(4), the method for determining biological quality of protein shall be the method prescribed on page 800 (secs. 39.166-39.170) under "Biological Evaluation of Protein Quality-Official, Final Action" of "Official Methods of Analysis of the Association of Official Analytical Chemists," 11th edition (1970).1

(ii) For the purpose of this paragraph (c)(4), the method for determining the amount of protein is to multiply by 6.25 the total nitrogen content in grams, as determined by the method described on page 16 (sec. 2.051) under "Improved Kjeldahl Methods for Nitrate-Free SamplesOfficial, Final Action" of "Official Methods of Analysis of the Association of Official Analytical Chemists," 11th edition (1970).

(5) If a quantity which supplies 100 available kilocalories of such food as customarily or usually prepared for consumption contains less than the following amounts of vitamins and minerals, a statement that an additional quantity of such vitamin(s) or mineral(s), as the case may be, should be supplied from other sources: