volume of liquid to preclude gastrointestinal injury.)

(iii) Any other labeling or additional advertising for the drug conforms to the labeling described in subdivision (ii) of this subparagraph, in accord with §§ 1.105 and 1.106(b) of this chapter.

(2) Within 90 days from the date of publication of this statement of policy in the FEDERAL REGISTER, the manufacturer, packer, or distributor of the drug shall submit a new-drug application containing satisfactory information of the kind required by Items 2, 3, 4, 6, 7, and 9 of the new-drug application form contained in § 130.4 (c) of this chapter, with appropriate labeling as described in this paragraph.

(b) The Food and Drug Administration may initiate regulatory proceedings after 30 days from the date of publication of this section, with respect to the marketing of uncoated tablets containing potassium chloride or other potassium salts which supply 100 milligrams or more of potassium per tablet or with respect to liquid preparations containing potassium chloride or other potassium salts which supply 20 milligrams or more of potassium per milliliter, labeled or intended for human use, unless all the following conditions are met:

(1) The labeling of the drug bears the prescription caution statement quoted in section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act; and

(2) The labeling on or within the package from which the drug is to be dispensed bears adequate information for its use by practitioners in accord with the "full disclosure" labeling requirements of § 1.106(b) of this chapter, including a recommendation that patients be directed to disslove any such tablets in an appropriate amount of liquid and to dilute any such liquid preparations adequately to assure against gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations.

(Secs. 502(f), 503 (b) (4), 505; 52 Stat. 1051, 1052; 21 U.S.C. 352(f), 353 (b), 355) [30 F.R. 5790, Apr. 24, 1965; 30 FR. 6071, Apr. 29, 1965] §3.16 Use of ox bile from condemned livers from slaughtered animals in the manufacture of drugs.

Conferences have recently been held between members of the Department of Health, Education, and Welfare and representatives of the Agricultural Research Service, Department of Agriculture,

concerning requests made to that agency for the release of ox bile from condemned livers of slaughtered animals for use in the manufacture of certain drugs.

The Secretary of Health, Education, and Welfare has given careful consideration to this problem and has reached the conclusion that no hazard to public health will be involved in the release of such ox bile, after the addition to it of sufficient sodium hydroxide to give the mixture a sodium hydroxide content of not less than 5 percent, the mixture then being allowed to stand at least 24 hours. This Department will not regard as in violation of the provisions of the Federal Food, Drug, and Cosmetic Act such alkalized and aged ox bile, if labeled "Ox Bile and Sodium Hydroxide (or Ox Bile and Sodium Hydroxide Solution). Sodium hydroxide not less than 5 percent by weight. For manufacturing use only." together with a statement of the quantity of contents in the container (for example, "50 gallons") and the name and address of the manufacturer, packer, or shipper.

Bile from the condemned livers of sheep and goats also may be released, under the same conditions as outlined in the preceding paragraph, except that the words "Sheep Bile" or "Goat Bile," as the case may be, shall be substituted for the words "Ox Bile" upon the label. In the case of mixtures of bile from any two or all three of the sources mentioned, the label shall indicate the sources of such bile.

[20 F.R. 9541, Dec. 20, 1955, as amended at 22 F.R. 10685, Dec. 25, 1957]

§3.17 Labeling of oleomargarine or margarine.

The Federal Food, Drug, and Cosmetic Act was amended by Public Law 459, 81st Congress (64 Stat. 20) on colored oleomargarine or margarine by adding thereto a new section numbered 407. Among other things, this section requires that there appear on the label of the package the word "oleomargarine" or "margarine" in type or lettering at least as large as any other type or lettering on the label, and a full and accurate statement of all the ingredients contained in such oleomargarine or margarine. provides that these requirements "shall be in addition to and not in lieu of any of the other requirements of this Act."

It

(a) Under section 403 (g) of the Federal Food, Drug, and Cosmetic Act, any article that is represented as or

purports to be oleomargarine or margarine must conform to the definition and standard of identity for oleomargarine or margarine promulgated under section 401 of the act (Part 4 of this chapter), and its label must bear the name "oleomargarine" or "margarine."

(b) The identity standard for oleomargarine or margarine applies to both the uncolored and the colored article. Although this standard does not require that all permitted optional ingredients be declared on the label, the amendment to the Federal Food, Drug, and Cosmetic Act made by Public Law 459, 81st Congress, requires the labels on packages of colored oleomargarine or margarine to bear "a full and accurate statement of all the ingredients contained in such oleomargarine or margarine." The optional ingredients permitted by the identity standard for oleomargarine or margarine and the names by which we believe such ingredients, when present, should be declared in order to constitute "a full and accurate statement" are set forth below:

(1) The rendered fat or oil, or stearin derived therefrom (any or all of which may be hydrogenated), of cattle, sheep, swine, or goats, or any combination of two or more such articles-to be declared by the name of the specific animal fat, oil, or stearin, for example, "beef fat." If the animal fat or oil is hydrogenated the name should include the word "hydrogenated" or "hardened." Where combinations are used, the names are to be arranged in order of predominance, with the animal fat, oil, or stearin present in greatest proportion named first.

(2) Any vegetable food fat or oil, or oil or stearin derived therefrom (any or all of which may be hydrogenated), or any combination of two or more such articles-to be declared by the name of the specific vegetable food fat, oil, or stearin, for example "cottonseed oil" or "soybean oil." If the vegetable fats or oils present are hydrogenated, the declaration should include the word "hydrogenated" or "hardened," for example, "hydrogenated cottonseed oil" or "hardened cottonseed oil." If two or more vegetable food fats or oils are used they are to be named in order of predominance with the one present in greatest proportion named first in the series, as, for example, "cottonseed oil, soybean oil, and corn oil."

(3) The optional ingredients cream, milk, skim milk, nonfat dry milk and water, ground soybeans and water, butter, and salt should be declared by those terms.

(4) Artificial color and artificial flavor should be declared as such by the terms prescribed in the identity standard for oleomargarine or margarine (Part 45 of this chapter). They need not be declared additionally by the names of the specific colors or flavors.

(5) The presence of sodium benzoate or benzoic acid should be declared as prescribed by the identity standard for oleomargarine or margarine.

(6) The optional ingredient vitamin A added in an essential carrier should be declared as "vitamin A added" or "with added vitamin A.”

(7) The optional ingredient vitamin D should be declared as "vitamin D added" or "with added vitamin D."

(8) The optional emulsifying ingredients lecithin, mono- or diglycerides and sodium sulfo-acetate derivatives of mono- or diglycerides should be declared by those terms.

(9) The presence of citric acid, isopropyl citrate, and stearyl citrate should be declared as prescribed by the identity standard for oleomargarine or margarine.

(10) The statement of all the ingredients contained in colored oleomargarine or colored margarine is subject to the requirements pertaining to conspicuousness in section 403 (f) of the act.

(c) In considering the requirement that the word "oleomargarine" or "margarine" be in type or lettering at least as large as any other type or lettering on the label, it must be borne in mind that at least three factors are involved-the height of each letter, the area occupied by each letter as measured by a closely fitting rectangle drawn around it, and the boldness of letters or breadth of the lines forming the letters. The type or lettering used should meet the following tests:

(1) The height of each letter in the word "olecmargarine" or "margarine" should equal or exceed the height of any other letter elsewhere on the label.

(2) The area of the closely fitting rectangle with respect to any of the letters in the word "oleomargarine" or "margarine" should equal or exceed the area of such rectangle applied to the same or a corresponding letter elsewhere on the label.

(3) The letters in the word "oleomargarine" or "margarine" should be equal to or exceed in prominence and boldness, such as breadth of lines forming the letters, the same or corresponding letters elsewhere on the label.

(d) All oleomargarine or margarine containing the optional ingredients vitamin A, vitamin D, or both is subject to the regulations regarding labeling requirements pertaining to foods for special dietary use, as promulgated under the provisions of section 403 (j) of the act (Part 125 of this chapter).

or

(e) The word "oleomargarine” "margarine" (and thus the other information called for by the statute) should appear on each panel of the package label that might reasonably be selected by the grocer for display purposes at the point of sale.

(f) The amendment covering colored oleomargarine or colored margarine states that, "for the purposes of

section 407 of the Federal Food, Drug, and Cosmetic Act, as amended, the term 'oleomargarine' or 'margarine includes: (1) All substances, mixtures, and compounds known as oleomargarine or margarine; (2) all substances, mixtures, and compounds which have a consistence similar to that of butter and which contain any edible oils or fats other than milk fat if made in imitation or semblance of butter." Notwithstanding the difference between this definition and the definition and standard of identity for oleomargarine or margarine promulgated under section 401 of the act, it was the clear intent of Congress that any article which is represented as or purports to be oleomargarine or margarine is misbranded if it fails to comply with the definition and standard of identity for oleomargarine or margarine even though it may meet the statutory definition.

(g) Section 407 (a) states that "Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this act as if it had been introduced in interstate commerce."

(h) Section 407 (b) (4) requires that each part of the contents of the package be "contained in a wrapper which bears the word 'oleomargarine' or 'margarine'

in type or lettering not smaller than 20point type." The Food and Drug Administration interprets this to mean that the height of the actual letters is no less than 20 points, or 20/72 of 1 inch.

(i) The wrappers on the subdivisions of oleomargarine or margarine contained within the packages sold at retail are labels within the meaning of section 201 (k) and should contain all of the label information required by sections 403 and pertaining to foods for special dietary use, as promulgated under the provisions 407 of the Federal Food, Drug, and Cosmetic Act, just as in the case of 1-pound cartons.

(Sec. 407, 64 Stat. 20; 21 U. S. C. 847) [23 F. R. 6552, Aug. 23, 1958]

§3.19 Notice to manufacturers, packers, and distributors of pasteurized process cheese, pasteurized blended cheese, pasteurized process cheese food, pasteurized process cheese spread, and related foods.

(a) Definitions and standards of identity have recently been promulgated under the authority of the Federal Food, Drug, and Cosmetic Act for a number of foods made in part from cheese, including pasteurized process cheese; pasteurized process cheese with fruits, vegetables, or meats; pasteurized blended cheese; pasteurized process cheese food; pasteurized process cheese spread, and related foods. These standards prescribe the name for each such food. The act requires that this name appear on the label. Many of these names consist of several words. In the past it has been the practice of some manufacturers to subordinate the words "pasteurized,” "blended," "process," "food," and "spread" to give undue prominence to the word "cheese" and to words naming the variety of cheese involved.

(b) When placing the names of these foods on labels so as to comply with the requirements of section 403(a), (f), and (g) of the act, all the words forming the name specified by a definition and standard of identity should be given equal prominence. This can readily be accomplished by printing the specified name of the food in letters of the same size, color, and style of type, and with the same background.

(c) Where the names of optional ingredients are required to appear on the

label, the designations of all such ingredients should be given equal prominence. The names of the optional ingredients should appear prominently and conspicuously but should not be displayed with greater prominence than the name of the food. The word "contains" may precede the names of the optional ingredients, and when so used will not be considered as intervening printed matter between name of food and name of optional ingredients required to be placed on the label.

(d) Where a manufacturer elects to include a label statement of fat and moisture content, the declaration should be on the basis of the food as marketed. A fat declaration on a moisture-free basis is likely to be misleading, and should not be used in labeling. [20 F.R. 9546, Dec. 20, 1955]

§ 3.20 Tolerances for moldy and insectinfested cocoa beans.

On and after February 22, 1963, shipments of cocoa beans offered for entry into the United States must meet a tolerance of 6 percent total moldy and insectinfested, including insect-damaged, beans, but not more than 4 percent of either moldy or insect-infested, including insect-damaged, beans. This statement of policy supersedes the notice issued August 27, 1931, addressed to shippers, importers, and dealers in cocoa beans and manufacturers of chocolate and cocoa products and the statement of policy issued June 22, 1961, in this section.

(Sec. 402 (a) (3), 68 Stat. 511; 21 U.S.C. 342 (a)(3)) [27 F.R. 6876, July 20, 1962]

(2) Additionally, new-drug applications have been approved for products containing:

Inositol hexanitrate. Isosorbide dinitrate. Octyl nitrite.

Pentaerythritol tetranitrate. Triethanolamine trinitrate biphosphate (trolnitrate phosphate).

(b) The Food and Drug Administration also finds that there is neither substantial evidence of effectiveness nor a general recognition by qualified experts that such drugs are effective for any of the other purposes for which some such drugs are promoted to the medical profession in labeling and advertising. In particular, neither clinical investigations nor clinical experience justify any representations that such drugs are effective in the management of hypertension; in the management of coronary insufficiency or coronary artery disease, except for their anginal manifestations; or in the management of the post coronary state, except angina pectoris present after coronary occlusion and myocardial infarction.

(c) Any preparation containing such drugs that is labeled or advertised for any use other than management of angina pectoris, or that is represented to be efficacious for any other purpose by reason of its containing such drug, will be regarded by the Food and Drug Administration as misbranded and subject to regulatory proceedings, unless such recommendations are covered by the approval of a new-drug application based on a showing of safety and effectiveness.

(d) Any such drug in long-acting dosage form is regarded as a new drug that requires an approved new-drug application before marketing.

(e) Any of the drugs listed in paragraph (a) (2) of this section is regarded as a new drug that requires an approved application. new-drug Articles for which new-drug approvals are now in effect should be covered by supplemental new-drug applications as necessary to provide for labeling revisions consistent with this policy statement.

(Secs. 502(f), 505; 52 Stat. 1051, 1052, 21 U.S.C. 352(f), 355) [31 F.R. 5957, Apr. 19, 1966]

Under the conditions specified in this section, the Secretary of Health, Education, and Welfare has determined that the public health will be adequately protected from any danger from the use of drugs, made in whole or in part from suprarenal glands of hogs that may be condemned by Federal inspectors of the Department of Agriculture after removal of such glands from the carcasses, arising from any abnormality of such carcasses if such glands are subjected to the following prescribed treatment, which will destroy or eliminate any microorganisms or toxins that might be present in the glands:

The glands are subjected to quick freezing promptly upon removal from the carcasses and maintained in a frozen state until they are ground and immersed in 95 percent to 100 percent acetone. The ground tissues remain in the acetone for a period of not less than 6 days, the mixture is filtered, and the residue is burned.

[20 F.R. 9547, Dec. 20, 1955]

§ 3.23 Notice to manufacturers and users of monosodium glutamate and other hydrolyzed vegetable protein prod

ucts.

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 by-product in the manufacture of purified monosodium glutamate but from which a substantial proportion of the monosodium glutamate has been removed.

(b) The statement of policy appearing in § 3.10 is reaffirmed. Monosodium glutamate is the common or usual name of the substance covered in said statement of policy. It need not be declared as an artificial flavoring, but when used as an ingredient of food products should be declared by its common or usual name. It may not be used in a food for which a standard of identity has been promulgated unless the standard or any amendment thereto recognizes it as an optional ingredient. It may not be used under any circumstances in such a way as to conceal damage or inferiority or make the article appear better or of greater value than it is.

(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 iiquid 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.