LIBELED: 1-5-60, E. Dist. Mich.

CHARGE: 502(a)—when shipped, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for eczema, fungus infections, psoriasis, ringworm, and athletes foot; and 502(f) (2)—the labeling of the article failed to bear a warning that its use should be discontinued if undue or unusual irritation of the skin developed and that frequent or prolonged use or application to large areas of the body may cause serious mercury poisoning.

DRUGS ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARD

6052. Lobie #1 tablets.

DRUGS FOR HUMAN USE*

(F.D.C. No. 43069. S. No. 25-122 P.)

INDICTMENT RETURNED: 9-14-59, S. Dist. Iowa, against Sentral Laboratories, Inc., Des Moines, Iowa, and James H. Roberts, president.

ALLEGED VIOLATION: On 11-25-57, the defendants gave to a firm engaged in the business of shipping drugs in interstate commerce, including Lobie #1 tablets supplied by the defendants, an invoice containing a guaranty that the Lobie #1 listed in the invoice was neither adulterated nor misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act.

On 11-25-57, the defendants sold, invoiced, and shipped a quantity of Lobie #1 tablets, which were adulterated, to the holder of the guaranty at Council Bluffs, Iowa.

LABEL IN PART:

(Drum) "50,000 Lobie #1 Each tablet contains: dl-Desoxyephedrine Hcl. 4 mg. Thyroid 1 gr. Atropine Sulfate 1/360 gr. Aloin 4 gr.” CHARGE: 501(c)-the strength of the article differed from that which it purported and was represented to possess, namely, 4 milligrams of dl-desoxyephedrine hydrochloride in each tablet, since each table of the article contained more than 4 milligrams of dl-desoxyephedrine hydrochloride.

PLEA: Guilty.

DISPOSITION: 12-3-59. Fines were assessed in the amount of $2,500 against the corporation and $1,000 against the individual, plus costs.

6053. Procaine hydrochloride injection.

48-822 P.)

(F.D.C. No. 43327. S. Nos. 48-543 P,

QUANTITY: 13,045 vials and 840 pkgs., 12 vials each, at San Francisco, Calif., in possession of Allied Biochemical Laboratories.

SHIPPED: Procaine hydrochloride was shipped on 1-29-59, from St. Louis, Mo. LABEL IN PART: (Vial) "30 cc. Sterile Procaine Hydrochloride Injection USP 1% [or "2%"]."

RESULTS OF INVESTIGATION: The procaine hydrochloride injection was manufactured by the dealer from the procaine hydrochloride which was shipped as described above. Examination of the article showed that the pH (acidity) of procaine hydrochloride was less than 3.3, whereas the United States Pharmacopeia requires that the pH of procaine hydrochloride injection be between 3.3 and 5.5.

CHARGE: 501 (b)-while held for sale, the quality of the article fell below the standard for procaine hydrochloride injection set forth in the United States Pharmacopeia; and 502(a)—the label statement "Procaine Hydrochloride Injection USP" was false and misleading. DISPOSITION: 10-5-59. Default-destruction.

6054. Del-Caps timed disintegration capsules.

45-496 P.)

QUANTITY: 8 1,000-capsule btls. at Tulia, Tex.

(F.D.C. No. 42794. S. No.

SHIPPED: 9-17-58, from Rensselaer, N.Y., by Delmar Pharmacal Corp. LABEL IN PART: "Del-Caps 15 Timed Disinegration Capsule *** Each Capsule Contains Dextro Amphetamine Sulfate 15 mg. * in a special base that provides for the disintegration of the contents throughout a period of 6-10 hours. *** 3565 Manufactured by Delmar Pharmacal Corp. 333 Co

lumbia Street, Rensselaer, New York." RESULTS OF INVESTIGATION: Analysis showed that each capsule contained 15 mg. of dextro-amphetamine sulfate, 77 percent of which was released in two hours.

LIBELED: 2-2-59, N. Dis. Tex. ; libel amended 5–12–59.

501 (c)—when shipped, the quality of the article differed from that CHARGE: which it purported and was represented to possess since it failed to distintegrate at a uniform rate over a 6-10 hour period; and 502(a)—the label statement "Each capsule contains Dextro Amphetamine Sulfate 15 mg.

in

a special base that provides for the disintegration of the contents throughout a period of 6-10 hours" was false and misleading. DISPOSITION: 1-15-60. Default-destruction.

DRUGS FOR VETERINARY USE

6055. Clotin. (F.D.C. No. 42878. S. No. 53-904 P.) QUANTITY: 10 cases, 12 tins each, at Springdale, Ark. SHIPPED: 10-29-58, from Omaha, Nebr., by Gland-O-Lac Co.

LABEL IN PART: (Tin) "Gland-O-Lac 2 Lb. 6 oz. (1.25 Kilos) CLOTIN A stabilized soluble Vitamin K effective without the addition of bile salts, for the prevention of Vitamin K deficiency in poultry and for the correction of hemmorrhagic disease due to such deficiency. Active Ingredient: Menadione Sodium Bisulfite, U.S.P. Each level teaspoonful (3 grams) contains 8.25 milligrams equal to 0.275%. Gland-O-Lac Company, Omaha, Nebr." RESULTS OF INVESTIGATION: Examination showed that the article contained substantially less than the declared amounts of menadione sodium bisulfite. LIBELED: 3-9-59, W. Dist. Ark.

CHARGE: 501 (c)-when shipped, the strength of the article differed from that which it purported and was represented to possess.

DISPOSITION: 8-4-59. Default-destruction.

6056. Medicated poultry feed. (F.D.C. No. 43058. S. Nos. 7-592 P, 7-887 P, 7-964 P.)

INFORMATION FILED: 12-4-59, Dist. Mass., against H. K. Webster Co., a corpo ration, Lawrence, Mass., and Walter N. Webster, vice president and treasurer of the corporation.

SHIPPED: Between 7-7-58 and 8-26-58, from Massachusetts and Vermont to New Hampshire and Maine.

LABEL IN PART: (Tag attached to bags) "CHICK STARTER MEDICATED" and "BLUE SEAL ALL-MASH GROW and LAY MEDICATED"; (invoice) "Growing Mash-Spec. Mix."

CHARGE: 501(d) (2)—products containing sulfaquinoxaline and no glycarbylamide had been substituted for products containing glycarbylamide and no sulfaquinoxaline; 502(a)-the statement on the labels of the Chick Starter and the Blue Seal Mash, namely, "Glycarbylamide *** 0.002%" was false and misleading since the products did not contain glycarbylamide; and 502(e) (2)—the labels of all products failed to bear the common or usual name of the active ingredient sulfaquinoxaline contained in the products.

DISPOSITION: 2-29-60, Fine of $300 against each defendant.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF FALSE AND MISLEADING CLAIMS*

6057. Various vitamin and mineral tablets. (F.D.C. No. 43612. S. Nos. 41963/76 P.)

QUANTITY: 2 bulk ctns., each containing 15,000 capsules, and 9 cases, each containing 12 100-capsule btls., of vitamin A 25,000 U.S.P. Units; 2 bulk etns., containing a total of about 21,000 capsules, and 11 cases, each containing (Howco brand) 12 100-capsule btls., and (Apothecary brand) 5 cases, each containing 24 100-capsule btls. of vitamin A 50,000 U.S.P. Units; 1 bulk ctn., containing about 22,000 capsules, 3 cases, each containing 24 150-capsule btls., and 150 unlabeled 150-capsule btls. of multiple vitamins; 1 bulk ctn., containing about 4,000 capsules, and 9 100-capsule btls. of Improved Vitamin Formula with Minerals and B12; 1 bulk ctn. containing about 40,000 tablets of vitamin B12 5 mcg.; 1 bulk ctn., containing about 8,000 tablets, and 25 cases, each containing 12 100-tablet btls., of vitamin B12 10 mcg.; 1 bulk ctn., containing about 30,000 tablets, and 7 cases, each containing 12 100-tablet btls. of vitamin B1 (thiamine) 25 mg.; 1 bulk ctn., containing about 30,000 tablets, and 13 cases, each containing 12 100-tablet btls., of vitamin B, (thiamine) 50 mg.; 1 bulk ctn., containing about 100,000 tablets, and 13 cases, each containing 12 100-tablet btls., of vitamin C (ascorbic acid) 50 mg.; 1 bulk ctn., containing about 90,000 tablets, and 60 250-tablet btls. of vitamin C (ascorbic acid) 250 mg.; 1 bulk ctn., containing about 281,000 tablets, 1 bulk ctn., containing about 117,000 tablets, 316 100-tablet btls. (Howco brand), and 7 cases, each containing 24 100-tablet btls. (Apothecary brand), of vitamin C (ascorbic acid) 100 mg., and 1 ctn. containing about 10,000 tablets and 13 cases, each containing 12 100-tablet btls. of vitamin B 5 mcg., at Seattle, Wash., in possession of Howe Products, Inc.

SHIPPED: Between 1-29-59 and 6-26-59, from Detroit, Mich.; San Francisco, Calif.; and Brooklyn, N.Y.

LABEL IN PART: (Btls.) "Howco Vitamin A *** 25,000 [or "50,000"] U.S.P. Units Distributor Howe & Co. Seattle"; "Apothecary Brand Multiple Vitamins ✦✦✦ As a dietary supplement for children and adults"; "Apothecary Brand Improved Therapeutic Vitamin Formula with Minerals and Bu • Distributed by Apothecary Products, Co., Seattle, Wash."; "Howco See also Nos. 6042, 6045, 6046, 6048, 6051, 6053, 6054, 6056.

Vitamin B Activity (from cobalemin concentrate NF) 10 mcg."; "Howco Vitamin B-1 *** 25 mg. [or "50 mg."]"; "Howco Vitamin C * * * 50 mg."; "Howco Vitamin C Ascorbic Acid USP 250 mg. [or “100 mg.”]."

ACCOMPANYING LABELING: Display cards entitled "Quality Vitamins," which hold one bottle and are used to display the "Apothecary Brand," and leaflets entitled "Vitamin Data" which accompany all the articles.

RESULTS OF INVESTIGATION: The articles in the bottles were repacked and relabeled by the dealer from bulk stock shipped as described above.

The display cards and the leaflets were printed locally at the dealer's request.

LIBELED: 11-3 59, W. Dist. Wash.

CHARGE: 502(a)--while held for sale, the labeling which accompanied the articles contained false and misleading representations as follows:

Vitamin A 25,000 and 50,000 U.S.P. Units (bulk and repacked), the statements "Common Name, Anti-infective; Anti-ophthalmic *** Function, Aids Growth & Vitality-Necessary for Reproduction Helps Prevent Infection, * * *peflelency Symptoms, Low resistance to Infection-Retarded GrowthLoss of Vigor-Night Blindness" were false and misleading since the article was not an adequate and effective treatment for, or preventive of, such conditions, since these conditions, namely, infections, low resistance to infections, ophthalmic disorders, retarded growth, low vitality, sterility, loss of vigor, and night blindness, implied or suggested by the labeling are rarely, if ever caused by a deficiency of vitamin A, and then only after a prolonged deficiency of vitamin A in the diet; and the statement "Natural Sources, Green vegetables, Tomatoes, Eggs, Butter" was false and misleading since vitamin A is abundantly available in many articles of food which comprise the normal diet and not only in those foods listed in the labeling.

Multiple vitamins (bulk and repacked), the statements "Function, One Capsule daily supplies a daily ration of all essential vitamins. Nutritional Supplement General resistance to colds and infections. Deficiency Symptoms Lack of resistance to colds and infections. Poor appetite and digestion" were false and misleading since the article was not an adequate and effective treatment for, or preventive of, lack of resistance to colds and infections, and the conditions, namely, poor appetite and digestion, are rarely, if ever, caused by a deficiency of the vitamins in the article and then only after a prolonged deficiency of such vitamins in the diet; such deficiencies being very rare in this country, since the vitamins listed on the label of the article are abundantly available in the many articles of food which comprise the normal diet.

Improved Therapeutic Vitamin Formula (bulk and repacked), the statements "Function, Aids people with high vitamin requirements. Correction of known vitamin and mineral deficiencies. Deficiency Symptoms, Lack of general good health and energy-colds and infections, sluggish skin" were false and misleading since the article was not an adequate and effective treatment for colds and infections; colds and infections are not symptoms of vitamin deficiencies; and the conditions, lack of general good health, and energy, listed for the article and the vitamins contained therein, are rarely, if ever, caused by a deficiency of these vitamins and minerals and then only after a prolonged deficiency of such vitamins and minerals in the diet; such deficiencies being very rare in this country since the vitamins and minerals contained in the article, as listed on the label, are abundantly available in the many articles

of food which comprise the normal diet and not only in those listed in the labeling.

Vitamin B12, 5 mcg. and 10 mcg. (bulk and repacked), the statements "Common Name-Anti-pernicious-anemia principle. Function, Helps prevent certain anemias, promotes growth. Deficiency Symptoms, Certain anemias, retarded growth in children Natural Source Liver (Beef)" were false and misleading since anemia is not a symptom of dietary deficiency of vitamin B1; the article is not an adequate and effective treatment for pernicious anemia or any other anemia, vitamin B12 is abundantly available in the many articles of food which make up the normal diet, and not only in the one listed in the labeling of the article; and since the condition, retarded growth, listed for the article, is rarely caused by a deficiency of vitamin B12.

Vitamin B1 (thiamine) 25 mg. and 50 mg. (bulk and repacked), the statements "Common Name-Anti-neuritic; Anti-beriberi. Function, Aids appetite and digestion. Helps some form of neuritis. Stimulates body activity, Deficiency Symptoms, Loss of appetite-fatigue-neuritis-depression. Natural Source, Yeast, wheat germ, milk" were false and misleading since vitamin B, is abundantly available in the many articles of food which comprise the normal diet and not only in those listed in the labeling of the article; and since the listed conditions, neuritis, poor appetite and digestion, loss of appetite, fatigue, depression, are rarely caused by a deficiency of vitamin B, and then only after a prolonged deficiency of vitamin B1 in the diet; and the article is not a stimulant to body activity except in severe cases of beriberi which is an extremely rare condition in this country.

Vitamin C (ascorbic acid) (bulk and repacked), the statements "Function, Assists in proper formation of bones and teeth-prevents scurvy. Deficiency Symptoms, Scurvy-tooth decay-hemorrhage-muscular weakness. Natural Source, Lemons, Oranges, Tomatoes, Grapefruit" were false and misleading since vitamin C is abundantly available in other articles of food which comprise the normal diet and not only in those listed in the labeling of the article; and since the listed conditions, tooth decay, hemorrhage, and muscular weakness are rarely caused by a deficiency of vitamin C and then only after a prolonged deficiency of vitamin C in the diet.

DISPOSITION: 11-23-59. Consent-claimed by Howe Products, Inc., and relabeled.

6058. Silhouettes capsules. (F.D.C. No. 43580. S. No. 75-206 P.)

QUALITY: 1 bulk drum containing about 7,000 capsules and 22 ctns., each containing 6 14-capsule boxes, at Chicago, Ill., in possession of N.D.L., Inc. SHIPPED: 9-12-59, from Long Island City, N.Y.

LABEL IN PART: (Bulk drum) "Timed Disintegration Capsules Phenyl Propanolamine Hydrochloride 75 mgm. Each capsule contains 75 mgm. Phenyl Propanolamine Hydrochloride in a special timed disintegration base that provides for prolonged therapeutic effect for about 6 to 10 hours" and (box) "Silhouettes *** An Effective Aid to Appetite Control Active Ingredient: 75 Mgs. Phenyl Propanolamine Hydrochloride."

RESULTS OF INVESTIGATION: The tablets in the boxes were repacked and relabeled from tablets in the bulk drum shipped as described above.

LIBELED: 10-7-59, N. Dist. Ill.

CHARGE: 502(a)—while held for sale, the labeling of the article and the name "Silhouettes" contained false and misleading representations that the article