Sec.

3.16 Use of ox bile from condemned livers from slaughtered animals in the manufacture of drugs. 3.17 Labeling of oleomargarine or margarine. 3.18 Drugs for use in milk-producing animals; labeling.

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.

3.20 Tolerances for moldy and insect-infested cocoa beans.

3.22 Suprarenal glands from hog carcasses prior to final inspection.

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

3.24 Notice to packers of comminuted tomato products.

3.25 Notice to manufacturers and labelers of antibiotic drugs for veterinary

Status of articles offered to the general public for the control or reduction of blood cholesterol levels and for the prevention and treatment of heart and artery disease under the Federal Food, Drug, and Cosmetic Act.

3.42 Status of folic acid in foods for special dietary use and as a drug.

3.43 Phenindione; labeling of drug preparations intended for use by man. 3.45 Sterilization of drugs by irradiation.

by man.

Subpart A-Formal Statements of

Policy or Interpretation 1

AUTHORITY: §§ 3.1 to 3.51 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses. §3.1 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization.

(a) Effective September 17, 1959, the exemption from the label declaration of ingredients requirements of section

403 (i) (2) of the Federal Food, Drug, and Cosmetic Act is terminated for the following foods:

Canned clams; canned fish roe; canned
shrimp (dry and wet pack).
Lemon extract; orange extract.
Malted milk.

Olives in brine. Sauerkraut.

Unmixed canned fruits, properly prepared and in sugar solution of not less than 20° Brix, not in excess of the amount necessary for proper processing, but with no other added substance.

Unmixed immature canned vegetables, properly prepared and with water not in excess of the amount necessary for proper processing, with or without added salt or sugar or both, but with no other added substance.

(b) The exemption from label declaration of ingredients requirements of section 403 (i) (2) of the Federal Food, Drug, and Cosmetic Act as applied to nonalcoholic carbonated beverages is continued until the effective date of a final order issued as a result of the proceedings started by the publication in the FEDERAL REGISTER Of September 14, 1963, of a notice proposing to establish a definition and standard of identity for this class of food.

(Sec. 403, 52 Stat. 1047; 21 U.S.C. 343) [26 F.R. 5369, June 15, 1961, as amended at 28 FR. 9982, Sept. 14, 1963]

§ 3.2 Notice to packers and shippers of shelled peanuts.

Investigations by the Food and Drug Administration have shown that a number of interstate shipments of shelled peanuts in bags holding from approximately 100 to 125 pounds each have failed to bear labeling as required by the terms of the Federal Food, Drug, and Cosmetic Act.

122 F.R. 9593, Nov. 30, 1957.

Shelled peanuts in sacks, whether or not shipped in carload lots, should bear the following information required by the law on food in package form:

(a) The name of the product.

(b) An accurate statement of net weight.

(c) The name and place of business of the packer or distributor.

This information should be conspicuously set forth. It may be printed or stenciled on each bag or, if desired, placed on tags which are securely attached to each bag.

The net weight marked on the bags must be the correct net weight of the peanuts at the time they are delivered to the carrier for interstate shipment. The tare weight of the bag should not be included in the weight declaration. [20 F.R. 9541, Dec. 20, 1955]

§ 3.3 Notice to manufacturers, packers, and distributors of glandular preparations.

Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201 (n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321(n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term "inert glandular materials" means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body.

Manufacturers have heretofore taken advantage of § 1.106 (b) of this chapter, permitting omission of directions for use when the label bears the prescription legend. Section 1.106 (b) (3) of this chapter requires that the labeling of the drug, which may include brochures readily available to licensed practitioners, bear information as to the use of the drug by practitioners licensed by law to administer it. Obviously, information adequate for the use of an inert gland

ular preparation is not available to practitioners licensed by law.

The Department of Health, Education, and Welfare is of the opinion that inert glandular materials may not be exempted from the requirements of section 502 (f) (1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include, among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to be misbranded if they are distributed for use as drugs.

The amended regulations provide also that in the case of drugs intended for parenteral administration there shall be no exemption from the requirement that their labelings bear adequate directions for use. Such inert glandular materials for parenteral use are therefore subject to the same comment as applies to those intended for oral administration.

[20 F.R. 9542, Dec. 20, 1955, as amended at 22 F.R. 10685, Dec. 25, 19571

§ 3.4 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.

In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn.

There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent "lipoid pneumonia."

In view of these facts, the Department of Health, Education, and Welfare will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indi

cates or implies that such drug is for administration to infants.

It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: "Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician."

This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.

[20 F.R. 9542, Dec. 20, 1955]

§ 3.5 Disposition of incubator reject eggs.

(a) Investigations by the Food and Drug Administration and a number of State regulatory agencies have revealed that incubator reject eggs, removed as infertile or otherwise unhatchable during hatching operations, are being diverted for human food use. Such eggs are regarded as adulterated within the meaning of section 402 (a) (3) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1046; 21 U.S.C. 342 (a) (3) because they are unfit for food.

(b) The introduction or delivery for introduction into interstate commerce of adulterated eggs is prohibited under section 301 (a) of the aforesaid act (52 Stat. 1042; 21 U. S. C. 331 (a) unless they have been broken, crushed, or smashed and then denatured with kerosene, creolin, or other suitable denaturant to preclude their diversion to human food channels.

(Secs. 301, 402, 52 Stat. 1042, 1046; 21 U. S. C. 331, 342) [23 F. R. 6834, Sept. 5, 1958] § 3.6 Notice to importers of Peruvian canned fish.

In collaboration with the United States Department of State and officials of the Government of Peru, the Food and Drug Administration of the Department of Health, Education, and Welfare has made a study in Peru of the canning of bonito and tuna packed for exportation to the United States. The fish known in Peru as bonito constitutes a major portion of the pack. Representative specimens of Peruvian bonito have been identified as the species Sarda chilensis. This confirms previous infor

mation that the species of fish constituting the commercial bonito fishery in Peru is the same species of bonito that has been packed in this country in small quantities and sold as bonito, for many years. Minor quantities of another bonito, Sarda velox, are apparently caught in Peruvian waters but do not enter the commercial pack to any significant degree. The bonitos, Sarda chilensis and Sarda velox, are not classified as tuna and under the provisions of the Federal Food, Drug, and Cosmetic Act have never been legally labeled as tuna, but must be labeled as "bonito" or "bonito fish."

Two species of tuna, "skipjac” (Katsuwonus pelamis) and "yellowfin" (Thunnus macropterus), are commercially canned in Peru but constitute a relatively small proportion of the Peruvian pack of canned fish exported to the United States.

Information developed during the investigation in Peru shows that the bonito (Sarda chilensis) can be readily distinguished from the tunas. Consequently no difficulty should be encountered by packers in keeping separate the fish in the two classifications and in properly labeling the canned product before shipment.

The provisions of the Federal Food, Drug, and Cosmetic Act require that importations of canned bonito and canned tuna, when offered for entry into the United States, must bear labels designating the product as "bonito" or as "tuna", as the case may be. Shipments that are unlabeled or mislabeled when offered for entry must be detained and are subject to refusal of admission, with consequent exportation or destruction. [20 F.R. 9542, Dec. 20, 1955]

§3.7 Potassium permanganate preparations as prescription drugs.

(a) There have been a number of reports in the medical literature of serious injuries to women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from physicians who have treated such cases show that the injuries are commonly caused by introducing tablets or crystals of potassium permanganate into the vagina. Experience with these cases shows that such use of potassium permanganate is not effective in producing abortion, but that instead the drug produces serious and painful injury to the walls of the vagina, causing ulcers, massive hemorrhage, and infection. Such

dangerous and useless employment of potassium permanganate is apparently encouraged among the misinformed by the mistaken idea that the vaginal bleeding caused by the corrosive action of the drug indicates a termination of pregnancy, which it does not.

son.

(b) Potassium permanganate is a strong oxidizing agent, a highly caustic, tissue-destroying chemical, and a poiThere are no circumstances under which crystals and tablets of potassium permanganate constitute safe dosage forms for use in self-medication. It is the consensus of informed medical opinion that the only dosage forms of potassium permanganate known to be safe for use in self-medication are aqueous solutions containing not more than 0.04 percent potassium permanganate. Such solutions are safe for use in self-medication only by external application to the skin.

(c) In view of the very real potentiality for harmful effect, and the actual injuries caused by the misuse of potassium permanganate, the Food and Drug Administration believes that in order adequately to protect the public health:

(1) Potassium permanganate and potassium permanganate tablets intended for human use are drugs subject to section 503 (b) (1) of the Federal Food, Drug, and Cosmetic Act and should be restricted to prescription sale. Such drugs will be regarded as misbranded if at any time prior to dispensing the label fails to bear the legend, "Caution: Federal law prohibits dispensing without prescription."

(2) Potassium permanganate labeled for use as a prescription component in human drugs under the exemption provided in § 1.106 (k) of this chapter or labeled for manufacturing use under the exemption provided in § 1.106 (1) will be regarded as misbranded unless the label bears the statement, "Caution: Federal law prohibits dispensing without prescription."

(3) These drugs will be regarded as misbranded when intended for veterinary use unless the label bears the legend, "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian”; Provided, however, That this shall not apply to a drug labeled and marketed for veterinary use if such drug contains not more than 50 percent of potassium permanganate and includes other ingredients which make it unsuitable for human use and unlikely

that the article would be used in an attempt to induce abortion.

(4) Any preparation of potassium permanganate intended for over-the-counter sale for human use internally or by application to any mucous membranes or for use in the vagina will be regarded as misbranded under the provisions of section 502(f) (1) and (2) and section 502 (j) of the act.

(5) Any other preparation of potassium permanganate intended for overthe-counter sale for human use will be regarded as misbranded under section 502(f) (1) and (2) and section 502(j) of the act unless, among other things, all of the following conditions are met:

(i) It is an aqueous solution containing not more than 0.04 percent potassium permanganate.

(ii) The label and labeling bear, in juxtaposition with adequate directions for use, clear warning statements designated as "Warning," and to the effect: "Warning-For external use on the skin only. Severe injury may result from use internally or as a douche. Avoid contact with mucous membranes."

(d) The labeling or dispensing of any potassium permanganate preparations intended for drug use within the jurisdiction of the Federal Food, Drug, and Cosmetic Act contrary to this statement after 60 days from the date of its publication in the FEDERAL REGISTER may be made the subject of regulatory proceedings.

(Secs. 502(f) (1), (2), (J), 503(b) (1), 705(b), 52 Stat. 1050, 1051, 1052, as amended, 1057; 21 U.S.C. 352(f) (1), (2), (j), 353(b) (1), 375(b)) [25 F.R. 8073, Aug. 23, 1960, as amended at 27 F.R. 1010, Feb. 3, 1962] §3.8 Amphetamine inhalers regarded as prescription drugs.

(a) Recurring reports of abuse and misuse of amphetamine inhalers show that they have a potentiality for harmful effect and that they should not be freely available to the public through over-thecounter sale. From complaints by lawenforcement officials, as well as from our own investigations, it is evident that the wicks from these inhalers are being removed and the amphetamine they contain is being used as a substitute for amphetamine tablets. Amphetamine tablets have always been restricted to prescription sale because of their potentiality for harm to the user.

(b) It is the considered opinion of the Food and Drug Administration that, in

order to adequately protect the public health, amphetamine inhalers should be restricted to prescription sale and should be labeled with the legend "Caution: Federal law prohibits dispensing without prescription."

(Sec. 503 (b) (1) (B), 52 Stat. 1052, as amended; 65 Stat. 648, 649; 21 U.S.C. 353 (b) (1) (B)) [24 FR. 967, Feb. 10, 1959]

§ 3.9 Label declaration of vitamin E in food for special dietary use.

(a) Section 125.3(a) (2) of this chapter, issued under the authority of section 403 (j) of the Federal Food, Drug, and Cosmetic Act (sec. 403 (j), 52 Stat. 1048; 21 U.S.C. 343 (j)) requires that if a food purports to be or is represented for special dietary use by man by reason, in whole or in part, of a vitamin for which the need in human nutrition has not been established, the label of such food shall bear the statement "The need for

in human nutrition has not been established," the blank to be filled in with the name of such vitamin.

(b) Heretofore the Food and Drug Administration has considered vitamin E as among those vitamins for which the need in human nutrition has not been established. However, in the opinion of nutrition scientists, recent evidence showed that this vitamin is needed in human nutrition. The scientific studies upon which this conclusion is based demonstrate that the vitamin E utilized in the physiological processes of the human body is that derived only from the diet. The Food and Drug Administration therefore considers the requirement of § 125.3(a) (2) of this chapter, quoted in paragraph (a) of this section as no longer applicable to food offered for special dietary use by reason of vitamin E.

(c) The difficulty of producing experimental dietary deficiency of vitamin E emphasizes that the diets used in this country are amply supplied with this vitamin. Any claim in the labeling of drugs or of foods offered for special dietary use by reason of vitamin E that there is need for dietary supplementation with vitamin E, will be considered false.

(Sec. 403(1), 52 Stat. 1048; 21 U.S.C. 343 (1)) [24 F.R. 8792, Oct. 29, 1959; 24 F.R. 8927, Nov. 3, 1959]

§ 3.10 Notice to manufacturers and users in food products of monosodium glutamate.

In the light of information now before the Food and Drug Administration on the manner of use of monosodium gluta