400 are children. In the emergency treatment of these poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical, since rapid treatment may be the difference between life and death. The restriction of this drug to prescription sale limits its availability in emergencies. On the other hand, it is the consensus of informed medical opinion that ipecac syrup should be used only under medical supervision in the emergency treatment of poisonings. In view of these facts, the question of whether ipecac syrup labeled as an emergency treatment for use in poisonings should be available over the counter has been controversial.

(b) In connection with its study of this problem, the Food and Drug Administration has obtained the views of medical authorities. It is the unanimous recommendation of the American Academy of Pediatrics, the American Association of Poison Control Centers, the American Medical Association, and the Medical Advisory Board of the Food and Drug Administration that ipecac syrup in 1 fluid ounce containers be permitted to be sold without prescription so that it will be readily available in the household for emergency treatment of poisonings, under medical supervision, and that the drug be appropriately packaged and labeled for this purpose.

(c) In view of the above recommendations, the Commissioner of Food and Drugs has determined that it is in the interest of the public health for ipecac syrup to be available for sale without prescription, provided that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and its label bears, in addition to other required label information, the following, in a prominent and conspicuous manner:

(1) A statement conspicuously boxed and in red letters, to the effect: "For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice."

(2) A warning to the effect: "Warning-Keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested."

(3) Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age. [30 FR. 13628, Oct. 27, 1965]

§ 3.31

Label declaration of salt in frozen vegetables.

(a) In a number of diseases or disease conditions it is important to restrict the intake of sodium. Sodium occurs in all natural foods, but added salt makes the most important contribution to the total sodium intake in the diet. Most fresh vegetables are of low sodium content and consumers generally regard frozen vegetables as being free of added salt and suitable for use in low-sodium diets. While salt may not be added directly as a seasoning ingredient during the processing of frozen vegetables, the use of salt brine in quality separation of such vegetables as peas and lima beans preparatory to freezing may contribute substantial amounts of salt to the finished article. The failure of the labels of frozen vegetables to declare the presence of salt has been the basis of complaints to the Food and Drug Administration.

(b) Section 403 (1) (2) of the Federal Food, Drug, and Cosmetic Act requires the label of a fabricated food to bear the common or usual name of each ingredient present. The Department of Health, Education, and Welfare regards any frozen vegetable containing salt, added directly or indirectly, as misbranded in violation of section 403 (1) (2) of the Federal Food, Drug, and Cosmetic Act unless its label names salt as an ingredient.

[20 F.R. 9549, Dec. 20, 1955]

§ 3.32

Label declarations of vitamin B1 and folic acid in foods for special dietary uses.

(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 this Department has considered vitamin B1 and folic acid as among those vitamins for which the need

in human nutrition has not been established. However, recent scientific evidence shows that these vitamins are needed in human nutrition. The Department therefore considers the requirement of § 125.3 (a) (2) quoted in paragraph (a) of this section as no longer applicable to food offered for special dietary use by reason of these vitamins.

(Sec. 403, 52 Stat. 1047, as amended; 21 U.S.C. 343) [20 FR. 9549, Dec. 20, 1955]

§ 3.33 Status of foods containing added

coumarin.

Manufacturers of coumarin have reported pharmacological investigations showing that it has toxic properties. They have informed the Food and Drug Administration that it will no longer be #sold for food use. The Federal Food,

Drug, and Cosmetic Act defines food as adulterated if it contains any added poisonous or deleterious substance not required in the production or avoidable in good manufacturing practice. Food containing coumarin added as such or as a constituent of tonka beans or tonka extract will be regarded as adulterated under this provision of the law.

(Secs. 402, 406, 52 Stat. 1046, as amended, 1049, as amended; 21 U.S.C. 342, 346) [20 F.R. 9549, Dec. 20, 1955]

§ 3.34 Labeling of imported crabmeat.

(a) For many years canned crabmeat has been imported into the United States from Japan. Such imports have consisted primarily of a product designated as "King crabmeat." There have been limited importations of articles designated as "Korean crabmeat" and "Snow crabmeat." Two closely allied species of crab have been packed in Japan for export to the United States, under the designation "King crabmeat.” These species are Paralithodes camtschatica

(taraba-gani) and Paralithodes platypus (abura-gani). A third species of crab, Paralithodes brevipes, has been labeled either as "King crabmeat" or "Hanasaki crabmeat" when intended for export to the United States. The Department of Health, Education, and Welfare considers the term "King crabmeat" as an acceptable common name for the product prepared from any one of the three species Paralithodes camtschatica, Paralithodes platypus, and Paralithodes brevipes. The Departbment also considers the name "Hanasaki

crabmeat" as an alternative common

name for the product prepared from Paralithodes brevipes.

(b) Prior to World War II, there was a limited pack of crabmeat from the species Erimacrus isenbeckii at canneries located on the coast of Korea, but only a small quantity of this product was imported into the United States. To distinguish the product from the various species of Paralithodes and to connote its geographic origin, the article was designated by the name "Korean crab." For the past several years there has been a limited amount of the species Erimacrus isenbeckii packed in Japan or on Japanese factory ships operating in the Bering Sea. This species of crab is generally known in Japan as "Kegani." This product, packed in Japan, when offered for entry into the United States has been designated by a variety of names, including "Korean crabmeat,' "Snow crabmeat," "Eliza crabmeat," "Kegani crabmeat," and "Zuwai crabmeat," with resulting confusion to importers and consumers. The term "Korean crab" is no longer applicable to the product as an indication of its geographic origin. The long absence of the product from the domestic market, until its recent reintroduction under a variety of names, has largely eliminated consumer recognition of the identity of the product under the name "Korean crabmeat." The Department therefore considers the designation “Korean variety crabmeat" or, alternatively, "Kegani crabmeat" as suitable common names for the product packed from the species Erimacrus isenbeckii.

(c) There has also been a limited pack of Chionectes opilio (zuwai-gani) offered for entry into the United States. This product has for many years been designated by the name "Snow crabmeat." The Department regards the designation "Snow crabmeat" as the common or usual name for the product when distributed in the United States.

(d) Section 403 (i) (1) of the Federal Food, Drug, and Cosmetic Act requires that the label of a food for which there is no definition and standard of identity shall bear the common or usual name of the food, if any there be. No definition and standard of identity has been established for crabmeat under the act. Department of Health, Education, and Welfare regards the label designations for canned crabmeat prepared from the various species of crab as stated in paragraphs (a), (b), and (c) of this section

The

as satisfactory compliance with section 403 (1) (1) of the act.

(Sec. 403, 52 Stat. 1047, as amended; 21 U.S.C. 343) [20 FR. 9549, Dec. 20, 1955] § 3.35 Labeling of drug preparations containing significant proportions of wintergreen oil.

(a) Because methyl salicylate (wintergreen oil) manifests no toxicity in the minute amounts in which it is used as a flavoring, it is mistakenly regarded by the public as harmless even when taken in substantially larger amounts. Actually, it is quite toxic when taken in quantities of a teaspoonful or more. Wintergreen oil and preparations containing it have caused a number of deaths through accidental misuse by both adults and children. Children are particularly attracted by the odor and are likely to swallow these products when left within reach.

(b) To safeguard against fatalities from this cause, the Department of Health, Education, and Welfare will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 percent methyl salicylate (wintergreen oil), the labeling of which fails to warn that use otherwise than as directed therein may be dangerous and that the article should be kept out of reach of children to prevent accidental poisoning.

(c) This statement of interpretation in no way exempts methyl salicylate (wintergreen oil) or its preparations from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.

(Sec. 502, 52 Stat. 1050, as amended; 21 U.S.C. 352) [20 F.R. 9549, Dec. 20, 1955]

§ 3.36 Thorium dioxide for drug use.

(a) Thorium dioxide is a source of naturally occurring radioactivity that has been used over a period of years as a radiopaque medium. When thorium dioxide is injected, it is permanently stored in the body. Because of its radioactivity, this storage causes scarring and carcinogenesis in the area of storage. There are reports in the medical literature of malignancy and deaths resulting from the injection of thorium dioxide. Therefore, the use in man of drugs containing thorium dioxide is justified only when this drug has a unique clinical usefulness and there is substantial evidence of limited life expectancy by reason of disease or advanced age. The admin

istration of the drug to food-producing animals cannot be justified since it may result in residues of the drug in food.

(b) Drugs containing thorium dioxide are unsafe and are regarded as misbranded within the meaning of section 502 (f) (1), (2), and (j) of the Federal Food, Drug, and Cosmetic Act when labeled or advertised for administration to man except when they have a unique clinical usefulness and there is substantial evidence of limited life expectancy by reason of disease or advanced age.

(c) Drug preparations containing thorium dioxide may be approved for marketing on the basis of new-drug applications containing labeling bearing, in addition to other requirements, information to the following effect, which differs substantially from the labeling that has been employed in the past in the marketing of such drugs:

(1) Warning. For use only when this drug has a unique clinical usefulness and there is substantial evidence of limited life expectancy by reason of disease or advanced age. Not for administration to food-producing animals.

(2) Precautions. Special precautions should be taken to prevent soft tissue extravasation of the injected material. Precautions should be taken to prevent injection of thorium dioxide into the subarachnoid space.

(3) Indications for use. For demonstration of primary or secondary tumors in the liver; for the delineation of the wall of a cystic malignant brain tumor when such delineation is deemed advantageous for purposes of progressive monitoring in the course of therapy.

(4) Dosage. Minimum amount necessary for adequate visualization should be utilized.

(d) A new-drug application will be regarded as approvable if it contains appropriate labeling conforming to the provisions of paragraph (c) of this section and satisfactory information of the kinds required by items 2, 3, 4, 6, 7, and 9 of the new-drug application form contained in § 130.4 (c) of this chapter.

(Secs. 502(f), 52 Stat. 1050 as amended; 21 U.S.C. 352 (f)) [30 F.R. 2104, Feb. 16, 1965] § 3.37 Acetophenetidin (phenacetin). containing preparations; necessary warning statement.

(a) In 1961, the Food and Drug Administration, pursuant to its statutory responsibility for the safety and effectiveness of drugs shipped in interstate

commerce, began an active investigation of reports of possible toxic effects and renal damage due to misuse of the drug acetophenetidin. This study led to the decision that there was probable cause to conclude that misuse and prolonged use of the drug were in fact responsible for kidney lesions and disease. The Commissioner of Food and Drugs, in December 1963, appointed an ad hoc Advisory Committee of Inquiry on Possible Nephrotoxicity Associated With the Abuse of Acetophenetidin (Phenacetin) -Containing Preparations. This committee, composed of scientists in the fields of pharmacology and medicine, on April 23, 1964, submitted its findings and conclusions in the matter and recommended that all acetophenetidin (phenacetin) -containing preparations bear a warning as provided in section 502(f) (2) of the Federal Food, Drug, and Cosmetic Act.

(b) On the basis of the studies made by the Food and Drug Administration and the report of the Advisory Committee, the Commissioner of Food and Drugs has concluded that it is necessary for the protection of users that the label and labeling of all acetophenetidin (phenacetin) -containing preparations bear a warning statement to the following effect: "Warning-This medication may damage the kidneys when used in large amounts or for a long period of time. Do not take more than the recommended dosage, nor take regularly for longer than 10 days without consulting your physician."

[29 F.R. 11418, Aug. 7, 1964]

§ 3.38 Declaration of quantity of contents on labels for canned oysters. (a) For many years packers of canned oysters in the Gulf area of the United States have labeled their output with a declaration of the drained weight of oysters in the containers. Packers in other areas have marketed canned oysters with a declaration of the total weight of the contents of the container. Investigation reveals that under presentday practice consumers generally do not discard the liquid packing medium, but use it as a part of the food. Section 403 (e) (2) of the Federal Food, Drug, and Cosmetic Act and the regulations thereunder require food in package form to bear an accurate label statement of the quantity of food in the container.

(b) It is concluded that compliance with the label declaration of quantity

of contents requirement will be met by an accurate declaration of the total weight of the contents of the can. The requirements of 36.6 of this chapter, establishing a standard of fill of container for canned oysters and specifying the statement of substandard fill for those canned oysters failing to meet that standard remain unaffected by this interpretation.

(Sec. 403, 52 Stat. 1047, as amended; 21 U.S.C. 848) [20 FR. 9550, Dec. 20, 1955] § 3.39 Use of vegetable fat in products which are imitations of ice cream.

There is currently being marketed in interstate commerce a frozen product made in semblance of ice cream, but containing vegetable fats in complete or partial substitution for milk fat. In some cases the product is marketed under a fanciful designation. Such a product is now regarded as an imitation of ice cream, and thus amenable to the provision of the Federal Food, Drug, and Cosmetic Act requiring the label to bear the name "Imitation Ice Cream," with all these words in type of uniform size and prominence, regardless of whether a fanciful designation is used.

(Secs. 402, 403, 52 Stat. 1046, as amended, 1047, as amended; 21 U.S.C. 842, 348) [20 FR. 9550, Dec. 20, 1955]

§ 3.40 Preparations for the treatment of pernicious anemia.

(a) The ninth announcement of the Anti-anemia Preparations Advisory Board of the United States Pharmacopeia is concerned with the status of the treatment of pernicious anemia. It clearly presents the following facts:

(1) The Sixteenth Revision of the Pharmacopeia of the United States, which became official on October 1, 1960, does not include preparations intended for the treatment of pernicious anemia by oral administration.

(2) The U.S.P. unit for anti-anemia preparations no longer has any signifi

cance.

(3) The U.S.P. Anti-anemia Preparations Advisory Board was disbanded.

(b) On the basis of the scientific evidence and conclusions summarized in the statement of the U.S.P. Anti-anemia Preparations Advisory Board as well as pertinent information from other sources, the Commissioner of Food and Drugs finds it is the consensus of wellinformed medical opinion that:

(1) The parenteral administration of cyanocobalamin or vitamin B is generally recognized as a fully effective treatment of pernicious anemia. Parenteral cyanocobalamin preparations have not been and are not authorized for use except by or on the prescription of a duly licensed medical practitioner.

(2) Some patients afflicted with pernicious anemia do not respond to orally ingested products. There is no known way to predict which patients will fail to respond or will cease to respond to the treatment of pernicious anemia with orally ingested preparations.

(3) The substitution of a possibly inadequate treatment, such as the ingestion of oral preparations of vitamin B, with intrinsic factor concentrate, in place of parenteral vitamin B products for a disease condition as serious as pernicious anemia cannot be regarded as safe in all cases.

(4) The development of the classical symptoms of pernicious anemia that would cause a person to seek medical attention may in some cases be delayed by oral ingestion of intrinsic factor. Pernicious anemia is a disease that is associated, among other things, with a higher than normal incidence of cancer of the stomach and that for the safety of the patient, requires continuous expert medical supervision.

(5) With inadequate treatment there may be markedly deleterious effects on the nervous system. It is well established that whereas the development of anemia is completely reversible with adequate treatment, the involvement of the nervous system may not be completely reversible and thus may result in permanent damage.

(6) Some hematologists prescribe oral preparations of vitamin B12 in the treatment of pernicious-anemia patients.

(7) Intrinsic factor and intrinsic factor concentrate serve no known useful therapeutic or nutritive purpose except to the extent that they do increase the gastrointestinal absorption of vitamin B12 in patients with a deficiency or absence of intrinsic factor, which may eventually lead to pernicious anemia. This conclusion does not apply to diagnostic procedures using radioactive

cyanocobalamin.

(8) Medical expertise is required for the diagnosis as well as the management of pernicious anemia.

(c) The Eleventh Edition of The National Formulary and its first Interim

Revision include monographs for oral preparations of vitamin B12 with intrinsic factor concentrate, establish a unit of vitamin B12 with intrinsic factor concentrate, and provide for a National Formulary Anti-anemia Preparations Advisory Board to assign the potency of such preparations. This provides for the availability of such oral preparations, standardized within the meaning of the broad limits characteristic of the evaluation of such preparations.

(d) Any drug that is offered for or purports to contain intrinsic factor or intrinsic factor concentrate will be regarded as misbranded within the meaning of section 503(b) of the Federal Food, Drug, and Cosmetic Act unless it is labeled with the legend "CautionFederal law prohibits dispensing without prescription."

(e) Any drug for oral ingestion intended, represented, or advertised for the prevention or treatment of pernicious anemia or which purports to contain any substance or mixture of substances described in paragraph (d) of this section (other than diagnostic drugs containing radioactive cyanocobalamin) will be regarded as misbranded under sections 502 (f) (2) and (j) of the act unless its labeling bears a statement to the effect that some patients afflicted with pernicious anemia may not respond to the orally ingested product and that there is no known way to predict which patients will respond or which patients may cease to respond to the orally ingested products. The labeling shall also bear a statement that periodic examinations and laboratory studies of pernicious-anemia patients are essential and recommended.

(f) Under section 409 of the Federal Food, Drug, and Cosmetic Act, intrinsic factor and intrinsic factor concentrate are regarded as food additives. No food additive regulation nor existing extension of the effective date of section 409 of the act authorizes these additives in foods, including foods for special dietary uses. Any food containing added intrinsic factor or intrinsic factor concentrate will be regarded as adulterated within the meaning of section 402(a) (2) (C) of the act.

(g) Regulatory action may be ini tiated with respect to any article shipped within the jurisdiction of the act contrary to the provisions of this policy statement after the 180th day following