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]

§3.18 Drugs for use in milk-producing animals; labeling.

(a) Section 146.14 of this chapter, covering certain antibiotic and antibioticcontaining drugs intended for use in milk-producing animals, applies only to preparations containing antibiotics subject to certification under section 507 of the Federal Food, Drug, and Cosmetic Act and is intended to prevent contamination of milk. The public-health factors involved, however, apply equally to any articles administered to milk-producing animals, even though those articles are not antibiotics subject to certification.

(b) The Food and Drug Administration considers that non-certifiable antibiotics and other potent drugs, as well as any preparation containing these, if labeled with directions for use in milkproducing animals, will be misbranded under section 502(f) (2) of the act unless their labeling bears appropriate warnings to avoid uses that would result in contamination of milk.

(c) It is the position of the Food and Drug Administration that the labeling for such preparations should bear a clear warning that either:

(1) The article should not be administered to animals producing milk, since to do so would result in contamination of the milk; or

(2) The label should bear a warning that the milk should be discarded for

hours after the latest use, the blank to be filled in with the number of hours (not to exceed 96) that the manufacturer has determined by appropriate investigation is needed to insure that the milk will not carry residues resulting from use of the preparation. If the use of the preparation as recommended does not result in contamination of the milk,

neither of the above warning statements is required.

(Sec. 502(f), 52 Stat. 1051; 21 U.S.C. 352(f)). [25 F.R. 8321, Aug. 31, 1960]

ess

§3.19 Notice to manufacturers, packers, and distributors of pasteurized proccheese, 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. 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.

The

(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 I 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]

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 new-drug application. 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]

§ 3.22 Suprarenal glands from hog carcasses prior to final inspection.

The Agricultural Research Service of the U.S. Department of Agriculture has informed the Food and Drug Administration of the Department of Health, Education, and Welfare that, under appropriate conditions, it will permit the removal of suprarenal glands from hogs that have not been finally inspected by Federal inspectors. The glands to be so obtained are intended for use in manufacturing extracts containing one or more of the therapeutically useful constituents of suprarenal glands.

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 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 paragraphs (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.

[20 FR. 9547, Dec. 20, 1955]

§ 3.24 Notice to packers of comminuted tomato products.

It has long been known that tomato rot may be caused by one or more of the following: Fungus diseases, bacterial diseases, virus diseases, and certain nonparasitic diseases. Only the fungus rots are characterized by the presence of mold filaments. Mold counts on comminuted tomato products are not increased by incorporating within the product tomato rot caused by bacteria, virus, or non

parasitic factors. Although high mold counts on these products reveal that large amounts of rotten material are present, low mold counts do not necessarily demonstrate absence of the type of rot caused by the tomato diseases that are not characterized by mold filaments. Inspections of canneries engaged in the packing of comminuted tomato products show that most packers effectively trim, sort out, and discard rotten tomatoes from the raw stock. Some packers, however, do not properly eliminate rotten tomato material, and a few packers deliberately use rotten tomatoes in these foods, provided the mold count remains low. Some packers, on occasion, have mixed tomato products having a high mold count with tomato products containing little or no mold, so as to produce a blend with a low mold count.

Packers of comminuted tomato products who rely upon the mold count as the sole or primary control procedure, to the neglect of adequate sorting and trimming, may produce products with low mold counts which contain substantial amounts of rot.

It is the purpose of this announcement to advise all canners of tomato products that:

(a) Although high mold count is conclusive evidence of inclusion of substantial amounts of rot, mold count is not the only way of establishing that comminuted tomato products contain decomposed tomato material.

(b) Where factory observations or other evidence reveals that comminuted tomato products contain rot not caused by mold, such rot, as well as that caused by mold, will be taken into account in applying the provisions of the Federal Food, Drug, and Cosmetic Act against adulteration.

(c) The blending of tomato products adulterated with tomato rot, of whatever kind, with tomato products made from sound tomatoes, or with other sound food, renders the blend adulterated. [20 F.R. 9547, Dec. 20, 1955]

§ 3.25 Notice to manufacturers and labelers of antibiotic drugs for veterinary use.

Unless a proper interval of time is allowed following the use of antibiotic drugs for the treatment of mastitis in milk-producing animals, the antibiotic drugs may get into the general milk supply. Because of the specific action of antibiotic drugs on cheese starters, milk

containing such drugs is of no value to cheese manufacturers.

The direct or inadvertent addition of antibiotic drugs to milk to be sold for human consumption or for the manufacture of dairy products may constitute an adulteration within the meaning of section 402 of the Federal Food, Drug, and Cosmetic Act (sec. 402, 52 Stat. 1046; 21 U. S. C. 342).

[20 F.R. 9541, Dec. 20, 1955, as amended at 27 F.R. 10452, Oct. 26, 1962]

CROSS REFERENCE: For required warning statements to be used in the labeling of antibiotic drugs intended for use in milkproducing animals, see 146.14 of this chapter.

§ 3.26 Labeling exemptions for foods repackaged in retail food establish

ments.

The Secretary of Health, Education, and Welfare will refrain from recommending criminal, injunction, or seizure proceedings on charges that a food repackaged in a retail establishment was misbranded, while held for sale, because it did not comply with the following provisions of the Federal Food, Drug, and Cosmetic Act, if the conditions herein specified are met:

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

(b) Section 403 (g) (2) (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 was 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 required by these provisions; or

(c) Section 403 (i) (1) (requiring the label to bear the common or usual name of the food), if the food was 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.

[20 F.R. 9548, Dec. 20, 1955]

§ 3.27

Status of fluoridated water and foods prepared__with_fluoridated water under the Federal Food, Drug, and Cosmetic Act.

(a) The program for fluoridation of public water supplies recommended by the Department of Health, Education, and Welfare, through the Public Health Service, contemplates the controlled addition of fluorine at a level optimum for the prevention of dental caries.

(b) Public water supplies do not ordinarily come under the provisions of the Federal Food, Drug, and Cosmetic Act. Nevertheless, a substantial number of inquiries have been received concerning the status of such water under the provisions of the act and the status, in interstate commerce, of commercially prepared foods in which fluoridated water has been used.

(c) The Department of Health, Education, and Welfare will regard water supplies containing fluorine, within the limitations recommended by the Public Health Service, as not actionable under the Federal Food, Drug, and Cosmetic Act. Similarly, commercially prepared foods within the jurisdiction of the act, in which a fluoridated water supply has been used in the processing operation, will not be regarded as actionable under the Federal law because of the flourine content of the water so used, unless the process involves a significant concentration of fluorine from the water. In the latter instance the facts with respect to the particular case will be controlling. [20 F.R. 9548, Dec. 20, 1955]

§ 3.28 Ophthalmic solutions and dis

pensers.

(a) Investigations by pharmaceutical manufacturers, physicians, and the Food and Drug Administration have revealed that liquid preparations for ophthalmic use contaminated with viable microorganisms have been responsible for serious eye injuries and, in some cases, loss of vision. The Administration has conducted a survey and has found that it is the consensus of informed medical opinion that such preparations should be sterile. It is evident that liquid preparations offered or intended for ophthalmic use, including cosmetic-type preparations for cleansing the eyes and contact-lens solutions, purport to be of such purity and quality as to be suitable for safe use in the eye. The Administration concludes that such preparations fall below their professed standard of

(1) Contain one or more suitable and harmless substances that will inhibit the growth of micro-organisms; or

(2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use.

(c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. They should be so packaged as to maintain sterility until the package is opened and be so labeled, on or within the retail package, as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use.

[29 F.R. 12458, Sept. 1, 1964]

§ 3.29 Chlorcyclizine, cyclizine, meclizine; warnings; labeling require

ments.

(a) The Food and Drug Administration, pursuant to its responsibility for the safety and effectiveness of drugs, has conducted active investigations of reports of available animal data which reveal that chlorcyclizine hydrochloride, cyclizine hydrochloride and lactate, and meclizine hydrochloride exert a teratogenic response in animals such as the rat, mouse, rabbit, pig, and dog. While clinical studies to date are inconclusive, scientific experts are of the opinion that these drugs may possess a potential for adverse effects on the human fetus. Investigations have led to the conclusion that there exists sufficient evidence of teratogenicity in animals administered these drugs to justify warnings against their use in pregnancy except on advice of a physician. An Ad Hoc Advisory Committee on the Teratogenic Effect of Certain Drugs, comprised of scientists in various branches of medicine concerned