used shall be required to make such a written certification only where he adds to or combines another flavor with a flavor which has been certified by a flavor supplier as containing no artificial flavor, but otherwise such user may rely upon the supplier's certification and need make no separate certification. All such certifications shall be retained by the certifying party throughout the period in which the flavor is supplied and for a minimum of three years thereafter, and shall be subject to the following conditions:

(i) The certifying party shall make such certifications available upon request at all reasonable hours to any duly authorized office or employee of the Food and Drug Administration or any other employee acting on behalf of the Secretary of Health, Education, and Welfare. Such certifications are regarded by the Food and Drug Administration as reports to the government and as guarantees or other undertakings within the meaning of section 301(h) of the act and subject the certifying party to the penalties for making any false report to the government under 18 U.S.C. 1001 and any false guarantee or undertaking under section 303(a) of the act. The defenses provided under section 303(c)(2) of the act shall be applicable to the certifications provided for in this section.

(ii) Wherever possible, the Food and Drug Administration shall verify the accuracy of a reasonable number of certifications made pursuant to this section, constituting a representative sample of such certifications, and shall not request all such certifications.

(iii) Where no person authorized to provide such information is reasonably available at the time of inspection, the certifying party shall arrange to have such person and the relevant materials and records ready for verification as soon as practicable: Provided, That, whenever the Food and Drug Administration has reason to believe that the supplier or user may utilize this period to alter inventories or records, such additional time shall not be permitted. Where such additional time is provided, the Food and Drug Administration may require the certifying party

to certify that relevant inventories have not been materially disturbed and relevant records have not been altered or concealed during such period.

(iv) The certifying party shall provide, to an officer or representative duly designated by the Secretary, such qualitative statement of the composition of the flavor or product covered by the certification as may be reasonably expected to enable the Secretary's representatives to determine which relevant raw and finished materials and flavor ingredient records are reasonably necessary to verify the certifications. The examination conducted by the Secretary's representative shall be limited to inspection and review of inventories and ingredient records for those certifications which are to be verified.

(v) Review of flavor ingredient records shall be limited to the qualitative formula and shall not include the quantitative formula. The person verifying the certifications may make only such notes as are necessary to enable him to verify such certification. Only such notes or such flavor ingredient records as are necessary to verify such certification or to show a potential or actual violation may be removed or transmitted from the certifying party's place of business: Provided, That, where such removal or transmittal is necessary for such purposes the relevant records and notes shall be retained as separate documents in Food and Drug Administration files, shall not be copied in other reports, and shall not be disclosed publicly other than in a judicial proceeding brought pursuant to the act or 18 U.S.C. 1001.

(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., "preservative", "to retard spoilage", "a mold inhibitor", "to help protect flavor" or "to promote color retention".

(Secs. 402, 403, 409, 701(a), 702, 703, 704, 52 Stat. 1046, 1047, 1048-1049 as amended, 1055, 1056-1057 as amended; 21 U.S.C. 342, 343, 348, 371(a), 372, 373, 374)

[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 3963, Jan. 19, 1979]

§ 101.25 Labeling of foods in relation to fat and fatty acid and cholesterol content.

(a) Implicit or explicit claims for the value of food in preventing or treating heart or artery disease can be misleading to consumers. However, a significant segment of the medical community is recommending that individuals modify their total diet by eliminating certain foods or by replacing certain foods with others in order to effect changes in the levels of blood components. Although there have been no definitive studies which have demonstrated beyond doubt that extensive changes in the consumption of fat and cholesterol by the general public are desirable, it is nevertheless appropriate to provide for informative labeling which will help individuals to identify foods for inclusion in fat-modified diets recommended by physicians. It is also appropriate to prohibit label statements which misrepresent specific foods as being, of themselves, of value in the control of the levels of these blood components or in the control of heart or artery disease.

(b) A food label or labeling may inIclude a statement of the cholesterol content of the food: Provided, That it meets the following conditions:

(1) The food is labeled in compliance with the provisions of § 101.9.

(2) The following information is inIcluded in the following order, in accordance with the provisions of

§ 101.9(c)(6)(ii):

(i) The cholesterol content, stated to the nearest 5-milligram increment per serving.

(ii) The cholesterol content, stated to the nearest 5-milligram increment per 100 grams of the food.

(iii) The statement required by paragraph (d) of this section.

(c) A food label or labeling may include information on the fatty acid content of the food: Provided, That it meets the following conditions:

(1) The food contains 10 percent or more fat on a dry weight basis and not less than 2 grams of fat in an average serving. Any food containing less than 10 percent total fat on a dry weight

basis and/or containing less than 2 grams of fat in a serving is not suitable for use by man as a means of regulating the intake of fatty acids.

(2) The food is labeled in compliance with § 101.9 and the following information is included in the following order in accordance with § 101.9(c)(6)(ii):

(i) The total fat content in terms of the percentage of the total calories in the food provided by fat with the heading "Percent of calories from fat".

(ii) The amount of fatty acids, calculated as the triglycerides, shall be stated in grams per serving to the nearest gram in the following two categories, stated with the following headings, in the following order, and displayed in equal prominence:

(a) Cis, cis-methylene-interrupted polyunsaturated fatty acids, stated as "Polyunsaturated";

(b) The sum of lauric, myristic, palmitic, and stearic acids, stated "Saturated"; and

as

(iii) The statement required by paragraph (d) of this section.

(d) A food labeled in accordance with paragraph (b) or (c) of this section shall display the following statement on the label: "Information (or "this information") on fat (and/or cholesterol, where appropriate) content is provided for individuals who, on the advice of a physician, are modifying their dietary intake of fat (and/ or cholesterol, where appropriate)."

(e) Compliance with this section shall be determined as follows:

(1) A collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking or, in the absence of any common container code or marking, a day's production, constitutes a "lot."

(2) The sample for analysis shall consist of a composite of 12 subsamples (consumer units), taken one from each of 12 different randomly chosen shipping cases, to be representative of a lot.

(3) Composites shall be analyzed for fat and saturated fatty acids by the methods of the Association of Official Analytical Chemists (AOAC). The

methods for fat, fatty acids, and cholesterol will be those of the Association of Official Analytical Chemists (AOAC), or other reliable and appropriate methods. Alternative methods of analysis may be submitted to the Food and Drug Administration to determine their acceptability. The determination of cis, cis-methylene-interrupted polyunsaturated fatty acids will be the Canadian Food and Drug Directorate Method FA-59' for cis, cismethylene-interrupted fatty acid.

(4) A food with a label declaration of cholesterol content shall be deemed to be misbranded under section 403(a) of the act if the content of the composite is greater than 20 percent in excess of the value for the cholesterol content declared on the label.

(5) A food with a label declaration of fat content shall be deemed to be misbranded under section 403(a) of the act if the content of the composite is greater than 20 percent in excess of the value for the fat content declared on the label or less than required by good manufacturing practices.

(6) A food with a label declaration of fatty acid content shall be deemed to be misbranded under section 403(a) of the act if the content of the composite is greater than 20 percent in excess of the value, or less than 80 percent of the value, for the fatty acid content declared on the label.

(f) Label statements made in accordance with paragraphs (b), (c), or (d) of this section shall comply with the requirements of § 101.2, but in no case may they be printed in larger than the minimum size type required by the provisions of § 101.105 for the declaration of net quantity of contents.

(g) No label or labeling may contain a claim indicating, suggesting, or implying that the product will prevent, mitigate, or cure heart or artery disease or any attendant condition. The principal display panel of the label may state "cholesterol (fat) information appears —— -," the blank to be filled in with a phrase stating where the information is contained. The statement shall appear in one-six

'Copies may be obtained from: Division of Nutrition (HFF-260), Bureau of Foods, Food and Drug Administration, 200 C Street SW., Washington, D.C. 20204.

teenth-inch type size or in the alternative in a type size no larger than onehalf the minimum type size required for the declaration of net quantity of contents by the provisions of § 101.105 of this chapter.

(h) No statements relating to cholesterol, fat or fatty acids, other than those expressly permitted by this section may be made. Any label or labeling containing any statement concerning cholesterol, fat or fatty acids which is not in conformity with this section shall be deemed to be misbranded under sections 201(n) and 403(a) of the act.

§ 101.29 Labeling of kosher and kosherstyle foods.

The term "kosher" should be used only on food products that meet certain religious dietary requirements. The precise significance of the phrase "kosher style" as applied to any particular product by the public has not been determined. There is a likelihood that the use of the term may cause the prospective purchaser to think that the product is "kosher." Accordingly, the Food and Drug Administration believes that use of the phrase should be discouraged on products that do not meet the religious dietary requirements.

(Sec. 402, 52 Stat. 1046; 21 U.S.C. 342)

§ 101.33 Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food.

(a) The article D-erythroascorbic acid (D-araboascorbic acid, D-erythro-3keto-hexonic acid lactone) has sometimes been designated as D-isoascorbic acid. However, this designation is capable of misleading purchasers of food in which it is used as an ingredient because of the similarity of such designation to the chemical name and the common name of vitamin C, which is ascorbic acid. Ascorbic acid (vitamin C) is capable of preventing the deficiency disease scurvy, but D-isoascorbc acid is ineffective for this purpose.

(b) The Joint Committee on Nomenclature of the American Institute of Nutrition and the Society of Biological Chemists has considered this matter, and pursuant to the Committee's rec

ommendation the respective scientific organizations approved a resolution to drop the use of the designation Disoascorbic acid and to adopt as a common name the name erythorbic acid for D-erythroascorbic acid.

(c) The compound D-erythroascorbic acid is not specified as an ingredient of any food for which a standard has been established. For foods other than those for which standards have been established, section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act requires that ingredients be listed on labels by their common or usual names. If the label on a food that contains D-erythroascorbic acid designates that ingredient by the name erythorbic acid, the requirement that the label bear the common or usual name of the ingredient will be regarded as having been met.

(Sec. 403, 52 Stat. 1047, as amended (21 U.S.C. 343))

§ 101.35 Notice to manufacturers and users of monosodium glutamate and other hydrolyzed vegetable protein products.

Following a review of various statements submitted by manufacturers and distributors of monosodium glutamate and various hydrolyzed plant protein products, the following conclusions have been reached:

(a) The facts submitted established that there are three classes of products to be considered:

(1) Purified monosodium glutamate. (2) Hydrolyzed proteins (amino acid salts) from which none of the monosodium glutamate has been removed.

(3) Hydrolyzed proteins (amino acid salts), a byproduct in the manufacture of purified monosodium glutamate but from which a substantial proportion of the monosodium glutamate has been removed.

(b) [Reserved]

(c)(1) The substance described in paragraph (a)(2) of this section has long been designated as "hydrolyzed vegetable protein."

(2) The substance covered by paragraph (a)(3) of this section should have a distinctive name, since one of its original constituents has been partially removed. Manufacturers have

suggested that this substance be described as “hydrolyzed vegetable protein with reduced monosodium glutamate content." This designation appears acceptable.

(d) While the substances referred to in paragraph (a) (2) and (3) of this section contain a number of amino acid salts as well as sodium chloride, monosodium glutamate is the ingredient which has been quite generally emphasized, and is best known to consumers under that name. No objection is offered under the Federal Food, Drug, and Cosmetic Act to the addition of a quantitative declaration on the labels of containers of such hydrolyzed vegetable protein or hydrolyzed vegetable protein with reduced monosodium glutamate content showing the percentage amounts of monosodium glutamate, the total of other amino acid salts, salt, and water, if in liquid form, all to be declared in the order of their decreasing percentages. If monosodium glutamate represents a smaller proportion of the substance than the other amino acid salts and salt (sodium chloride), it should be declared last in the list of ingredients.

(e) When the substances described in paragraph (a) (2) and (3) of this section are used as ingredients in a fabricated food, either may be declared as "salt and hydrolyzed vegetable protein" (or "salt and hydrolyzed plant protein") on the label of the fabricated food product: Provided, That where salt is declared as a separate ingredient of the fabricated food, in compliance with section 403(i)(2) of the act, the word "salt" need not be repeated in connection with the "hydrolyzed vegetable protein" (or "hydrolyzed plant protein") declaration.

Subparts C through E—[Reserved]

Subpart F-Exemptions From Food Labeling Requirements

§ 101.100 Food; exemptions from labeling. (a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each in

gredient when the food is fabricated from two or more ingredients).

(1) An assortment of different items of food, when variations in the items that make up different packages packed from such assortment normally occur in good packing practice and when such variations result in variations in the ingredients in different packages, with respect to any ingredient that is not common to all packages. Such exemption, however, shall be on the condition that the label shall bear, in conjunction with the names of such ingredients as are common to all packages, a statement (in terms that are as informative as practicable and that are not misleading) indicating by name other ingredients which may be present.

(2) A food having been received in bulk containers at a retail establishment, if displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter card, sign, or other appropriate device bearing prominently and conspicuously the information required to be stated on the label pursuant to section 403(i)(2) of the act.

(3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are:

(i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect.

(ii) Processing aids, which are as follows:

(a) Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form.

(b) Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constitutents naturally found in the food.

(c) Substances that are added to a food for their technical or functional

effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food that are not food additives as defined in section 201(s) of the act; or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act.

(b) A food repackaged in a retail establishment is exempt from the following provisions of the act if the conditions specified are met.

(1) Section 403(e)(1) of the act (requiring a statement on the label of the name and place of business of the manufacturer, packer, or distributor).

(2) Section 403(g)(2) of the act (requiring the label of a food which purports to be or is represented as one for which a definition and standard of identity has been prescribed to bear the name of the food specified in the definition and standard and, insofar as may be required by the regulation establishing the standard the common names of the optional ingredients present in the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other appropriate device bearing prominently and conspicuously the information quired by these provisions.

re

(3) Section 403(i)(1) of the act (requiring the label to bear the common or usual name of the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other appropriate device bearing prominently and conspicuously the common or usual name of the food, or if the common or usual name of the food is clearly revealed by its appearance.

(c) An open container (a container of rigid or semirigid construction, which is not closed by lid, wrapper, or otherwise other than by an uncolored transparent wrapper which does not obscure the contents) of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than 1 dry quart, shall be exempt from the labeling requirements of sections 403(e),