Sec.

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 dia

betics 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. (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 miner

als 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.

(Secs. 409, 701(e), 706, 70 Stat. 919 as amended, 72 Stat. 1784-1788 as amended, 74 Stat. 399-407 as amended (21 U.S.C. 348, 371(e), 376))

[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 caloric intake or body weight.

(a) General requirements. Any food that purports to be or is represented for special dietary use because of usefulness in maintaining or reducing caloric intake or body weight, including, but not limited to, any food that bears representations that it is low or reduced in calories, shall bear:

(1) Nutrition labeling in conformity with § 101.9 of this chapter, unless exempt under that section; and

(2) The labeling provided for in paragraph (c) or (d) of this section, or a conspicuous statement of the basis upon which the food claims to be of special dietary usefulness.

(1)

(b) Nonnutritive ingredients. 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 caloric intake or 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 nonnutritive sweetener(s) is added, the statement shall indicate the presence of both type of sweeteners, e.g., "Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s)."

(c) "Low calorie" foods. (1) A food may purport to be or be represented as "low calorie" only if:

(i) A serving of the food supplies no more than 40 calories, and

(ii) The food does not provide more than 0.4 calorie per gram, as consumed, or is a sugar substitute, and

(iii) The food bears on its principal display panel the term "low calorie," "low in calories," or "a low calorie food".

(2) Foods that are low calorie within the meaning of paragraph (c)(1) of this section, as naturally occurring, without having any fabrication or alteration, may be labeled as a low calorie food, e.g., "celery, a low calorie food." They may not be labeled with the term "low calorie" immediately preceding the name of the food because such terminology would imply that the food has been altered to lower its calories with respect to other foods of the same type.

(d) "Reduced calorie" foods, and other comparative claims. (1) A food may be labeled as "reduced calorie," or with other terms representing or suggesting special dietary usefulness on the basis of a fabrication or alteration that makes the food lower in calories than a food it can substitute for in the diet only if:

(i) A comparison of the calorie content of a specified serving of the food with the calorie content of an equivalent serving of the same food without the fabrication or alteration of special dietary significance reveals a calorie reduction of at least one-third;

(ii) The food bears on its label a statement that clearly and concisely describes the comparison upon which the claim of special dietary usefulness

is made. The statement shall either identify a specific food having at least one and a half times as many calories per serving for which the food can substitute, or indicate that the claim of special dietary usefulness is based on a comparison with the same food without the fabrication or alteration of special dietary significance. The statement shall also include a comparison between the calorie content of a specified serving of the food and an equivalent serving of the food it substitutes for, or the same food without the fabrication or alteration of special dietary significance, and

(iii) The food is not nutritionally inferior, under the criteria set forth in § 101.3(e) of this chapter, to the food for which it substitutes or the same food without the fabrication or alteration of special dietary significance.

(2)(i) Any food subject to this paragraph (d) that is similar in all its organoleptic properties to the food it is represented as substituting for, or to the food without the fabrication or alteration of special dietary significance, shall be labeled as "reduced calorie,' "reduced in calories," or "a reduced calorie food."

(ii) Any food subject to this paragraph (d) that does not resemble in all its organoleptic properties the specific food for which it substitutes, e.g., canned pears packed in unsweetened water, in comparison with pears in heavy syrup, may be labeled with appropriate terms to indicate its dietary usefulness, but in immediate proximity such labeling shall indicate material differences in organoleptic properties between it and the food to which it is compared. The food shall not bear terms in juxtaposition with its name or in the labeling that represent or suggest that the food is essentially the same as the other food in all its organoleptic properties except for a reduction in calories.

(3) It may not be technologically feasible to manufacture a "reduced calorie" food under the criteria set forth in this paragraph for all foods that are significant dietary sources of calories and for which it would be useful to those on calorie-restricted diets to have a reduced calorie substitute. Accordingly, the Commissioner

or

may establish by regulation acceptable alternative criteria for a "reduced calorie" food, in a regulation issued pursuant to section 401 of the act establishing a standard of identity for the food, in a regulation in part 102 of this chapter establishing a common usual name for the food, in an amendment to this section, or in a regulation issued pursuant to sections 201(n) and 403(a) of the act. A petition requesting such a regulation shall be submitted to the Dockets Management Branch in the form established by Part 10 of this chapter. Under no circumstances will a food be permitted to be labeled as "reduced calorie" unless (i) the petition demonstrates that it is not feasible to attain a greater caloric reduction than that for which approval is sought and (ii) the petition demonstrates that the use of the food, with the caloric reduction attained, will result in a significant reduction in calories in the diet and be useful to those on weight control programs.

(e) Label terms suggesting usefulness as low calorie or reduced calorie foods. (1) Except as provided in paragraphs (e) (2) and (3) of this section, a food may be labeled with terms such as "diet," "dietetic," "artificially sweetened," "sweetened with nonnutritive sweetener," or other such terms representing or suggesting that the food is low calorie or reduced calorie or that the food may make a comparative claim of special dietary usefulness, only if: The food is labeled "low calorie" or "reduced calorie" or bears a comparative claim of special dietary usefulness in compliance with paragraph (c) or (d) of this section.

(2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by a regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term "diet," which clearly shows that the food is offered solely for dietary use(s) other than regulating caloric intake or 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, low calorie meal, or other food that is represented to be of special die

tary use as a whole meal, pending the issuance of a regulation governing the use of such terms on such foods.

(f) Use of terms such as "sugar free," "sugarless," "no sugar, etc. (1) Consumers may reasonably be expected to regard terms that represent that the food contains no sugars or sweeteners, e.g., "sugar free," "sugarless," "no sugar," as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (f)(2) of this section, a food may not be labeled with such terms unless:

(i) It is labeled "low calorie" or "reduced calorie" or bears a comparative claim of special dietary usefulness labeled in compliance with paragraph (c) or (d) of this section, or

(ii) Such term is immediately accompanied, each time it is used, by the calorie statement "Not a reduced

food," "Not a low calorie food,"""Not for weight control," "Useful Only In Not Promoting Tooth Decay," or other term indicating that the sole special usefulness of the food is for a specified purpose other than weight control.

(2) Paragraph (f)(1) of this section shall not apply to a factual statement that a food is unsweetened or contains no added sweeteners in the case of a food that contains apparent substantial inherent sugar content, e.g., juices. [43 FR 43259, Sept. 22, 1978; 43 FR 52700, Nov. 14, 1978]

§ 105.67 Label statement relating to food for use in the diet of diabetics.

(a) A food that purports to be represented for special dietary use because of usefulness in the diet of diabetics shall bear nutrition labeling in compliance with § 101.9 of this chapter, unless exempt under that section, and the statement "Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food." If the food is useful in maintaining or reducing calorie intake or body weight and labeled in conformity with § 105.66, the last sentence may be eliminated.

(b) A food shall not be represented to be useful in the diets of diabetics if such representation is false or misleading.

(c) The term "diabetic," "for diabetics," "diabetes," or the like, shall not be included as part of the name of any food, or otherwise be included on the labeling more prominently than the statement required by paragraph (a) of this section.

(d) The term "dietetic," "diet," or the like, shall not be included in the labeling of a food solely because of its possible usefulness in the diet of diabetics.

(e) A food shall not purport to be or be represented for special dietary use because of usefulness in the diet of diabetics solely by virtue of its being a food useful in reducing or maintaining caloric intake or body weight.

[43 FR 43259, Sept. 22, 1978]

§ 105.69 Foods used to regulate sodium intake.

If a food purports to be or is represented for special dietary use by man by reason of its use as a means of regulating the intake of sodium or salt (sodium chloride), the label shall bear either nutrition labeling or a statement of the number of milligrams of sodium in a specified serving (portion) of such food, in conformance with the applicable provisions of § 101.9 of this chapter.

(Secs. 201, 403, 701, 52 Stat. 1040-1042 as amended, 1047-1048 as amended, 1055 (21 U.S.C. 321, 343, 371))

[49 FR 15534, Apr. 18, 1984]

Sec.

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: Secs. 412, 701(a), 52 Stat. 1055, 94 Stat. 1190 (21 U.S.C. 350a, 371(a)). 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.

at any point in the manufacturing process before packaging.

(c) Manufacturer. A manufacturer is a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula and/or packages the product in a container for distribution.

(d) Nutrient. A nutrient is any vitamin, mineral, or other substance required in accordance with the table set out in section 412(g) of the act or by regulations promulgated under section 412(a)(2)(A) of the act.

(e) Nutrient premix. A nutrient premix is a combination of ingredients containing two or more nutrients. A nutrient premix either may be received from a supplier or be prepared by an infant formula manufacturer.

Subpart B-Quality Control Procedures for Assuring Nutrient Content of Infant Formulas

§ 106.20 Ingredient control.

(a) Except as provided in § 106.20(b), no analysis before use in manufacturing is needed for ingredients that are generally stable in shipping and storage, and that either are received under a supplier's guarantee or certification that the mixture has been analyzed as to nutrient composition or are labeled as having nutrient compositions complying with specifications in the U.S. Pharmacopeia, the National Formulary, the Food Chemicals Codex, or other similar recognized standards.

(b) Unless each batch of finished product is analyzed as specified in § 106.30(b)(1) before release of product for commercial or charitable distribution, the following shall apply:

(1) When an ingredient is relied upon as a source of a nutrient(s) and when evidence indicates that such nutrient(s) in that ingredient is likely to be affected adversely by shipping or storage conditions, the manufacturer shall analyze that ingredient for each relied-upon nutrient that may be affected, using validated analytical methods.

(2) Ingredients, including nutrient premixes, that are either without a supplier's guarantee or certification, or not labeled as complying with pre