btls of Vis-Vitae; 156 100-tablet btls. and 348 50-tablet btls. of M. O. F. #101 Vigorgy Tonik-Tabs; 142 100-capsule btls. and 360 50-capsule btls. of Calmettes; and 82 100-capsule btls. and 180 50-capsule btls. of Hipote LivIron; at Lexington (Red Bank), S.C., in possession of House of Nutritive Formulas. SHIPPED: 10-22-58, from Long Island City, N.Y. Camphor LABEL IN PART: "Capsules Merci-Caps *** Each Capsule contains: Salicylamide 4.4 Grains Caffeine 1.0 Grains Phenacetic 1.5 Grains Monobromated 1.0 Grains P. E. Belladonna 2/25 Grains *** Distributed by House of Nutritive Formulas 604 West Palmetto Street, Florence, S.C."; "14/263 Fema-Formula Capsules *** Distributed by House of Nutritive Formulas *** Each Fema-Formula Capsule contains: Ferrous Sulfate USP 3-% gr. Whole Liver Dessicated 7 grs. Supplemented to contain approximately: Thiamine Chloride (B-1) 0.5 mg. Riboflavin (B-2) 1.0 mg. Nicotinamide 5 mg. Vitamin B-12*** 1 mcgm. Folic Acid 0.05 mgm."; "53/163 Vis-Vitae (Vigor of Life) Capsules *** Distributed by House of Nutritive Formulas *** 604 West Palmetto Street, Florence, S.C. 31310 Each capsule contains: * * L-Lysine monohydrochloride 7.5 mgm. Vitamin A*** 12,500 USP Units *** Vitamin D * * * 0 1000 USP Units * * Thiamin mononitrate (Vitamin B1) 5 mgm. * * * Riboflavin (Vitamin B2) 5 mgm. * Pyridoxine HCl (Vitamine B.) 1 mgm. * * * Folic Acid 0.5 mgm. * * Ascorbic Acid 75 mgm. * * * Niacinamide 40 mgm. ✦✦✦ Calcium Pantothenate 4 mgm. *** Vitamin B-12 (Cobalmin) 2 mcgm. Vitamin E (from D-Alpha tocopheryl acid Succinate) 21 U. *** Choline Bitartrate 31.4 mgm. *** Inositol 15 mgm. d-1 Methionine 10 mgm. Calcium *** 75 mgm. *** Phosphorous * * * 52 mgm. *** Cobalt * * 0.04 mgm. * Iron * * * 30 mgm. ✦✦✦ Copper *** 0.45 mgm. * * Magnesium *** 3 mgm. mgm. Iodine * * Molybdenum *** 0.1 mgm. *** Zinc * * * 0.5 0.1 mgm. Manganese * ** 0.5 mgm. * Potassium ** 2 mgm. * Liver Whole Desiccated 50 mgm. *** Vitamin B-12 USP 1/100 USP Units Hesperidin purified 5 mgm. * Rutin 2.5 mgm"; "M.O.F. #101 Vigorgy Tonik-Tabs (Formula for Men) *** Distributed by House of Nutritive Formulas * 604 West Palmetto Street, Florence, S.C. 38812 Each tablet contains: Calcium Glycerophosphate 150 Mg. Tricalcium Phosphate 225 Mg. Ferric Hypophosphite 250 mg. Thiamin Chloride 15 mg. Vitamin B-12 (Cobalamin Conc.) 10 Mcg. Strychnine Sulfate 0.325 Mg."; "Calmettes *** Distributed by House of Nutritive Formulas *** 604 West Palmetto Street, Florence, S.C. 39566 Each *** Calmette Capsule contains: Thiamin HCl 10 mgm. Riboflavin 10 mgm. Niacinamide 100 mgm. Calcium Pantothenate 20 mgm. Pyridoxine HCl 2 mgm. Folic acid 1.5 mgm. Ascorbic acid 300 mgm. Vitamin B-12 (cobalamin conc.) 4 megm."; and “52/134 Hipote Liv-Iron Superhema Capsules The New Lease on Life Capsule Distributed by House of Nutritive Formulas * * * 604 West Palmetto Street, Florence, S.C. 39606 Each capsule contains: Intrinsic Factor with Vitamin B-12 1⁄2 U.S.P. Unit Liver-stomach concentrate 175 mg. Vitamin B-12 Cobalamin Conc. 10 mcg. Folic Acid 1 mgm. Ferrous sulfate exsiccated 400 mgm. Ascorbic Acid 75 mgm." ACCOMPANYING LABELING: Advertising mats headed “Are You A Once-A-Month Invalid?", "Your Health is Priceless," "For Your Good Health," "Get That 'Man Alive' Feeling," "Keep Calm With Calmettes," and "Add Life To Your Years."; catalogues reading in part “Winter-Spring 1958–59 *** Lexington, S.C." and "Winter-Spring 1958-59 * * * Lexington, S.C."; and leaflets on House of Nutritive Formulas letterhead beginning "Dear Friend." LIBELED: 10-21-59, E. Dist. S.C. CHARGE: 502(a)-while held for sale, the labeling which accompanied the articles contained false and misleading representations that the articles were an adequate and effective treatment (Merci-Caps) for migraine headache, bronchial asthma, and hayfever; (Fema-Formula) to build stronger blood; to produce good health; for painful menstruation, periodic cramps and irregularities; tired spells, tenseness, "periodic blues," nervousness, and depression; (Vis-Vitae) for premature aging; abnormal tiredness; mental strain and forgetfulness; digestive upsets; loss of appetite; susceptibility to colds and infection; run-down conditions; to produce vim, vigor and vitality and good health, and to stay well; (Vigorgy Tonik-Tabs) to produce energy, vigor and vitality; restore health, strength, manly vigor and sexual potency of men; (Calmettes) for nervous tension; stress conditions; physical and emotional upsets; upsets caused by business worry and over-indulgence: "jumpy feelings"; stress after serious injury such as burns; fracture of the long bones, and surgery; nervous breakdown; (Hipote Liv-Iron) for listless, pale, wan and worn, tired and run-down conditions; tired blood; loss of red blood cells; chills; shortness of breath; cold hands and feet; anemia; to restore healthy good looks, strength, and strong blood; to revitalize the entire system of the body and to pep up iron starved blood after colds, flu, or infec tions; and, in addition, the labeling accompanying the Fema-Formula, VisVitae, Vigorgy Tonik-Tabs, Calmettes, and Hipote Liv-Iron and consisting of the "Vitamin-Data" chart appearing in the catalogue reading in part “WinterSpring 1958-59 ***Florence, S.C." contained false and misleading representations that the Fema-Formula, Vis-Vitae, Vigorgy Tonik-Tabs, Calmettes, and Hipote Liv-Iron would be adequate and effective in the treatment and prevention of the diseases and symptoms listed in the chart under the headings "Functions" and "Deficiency Symptoms" and in producing the listed beneficial effects, namely, that the articles were adequate and effective in treating and preventing, low resistance to infection; retarded growth; loss of vigor; night blindness; loss of appetite; fatigue; neuritis; depression; nervous disorders; growth and digestive disturbances; skin disorders; nervous and intestinal disturbances; certain anemias; retarded growth in children; scurvy; tooth decay; hemorrhage; muscular weakness; rickets; bone deformities; failure of reproduction; and that the articles would aid growth and vitality necessary for reproduction; help prevent infection; aid appetite and digestion; help some forms of neuritis; stimulate body activity; induce normal cell growth and development; aid in prevention of pellagra; aid in prevention of skin and nervous disorders; help prevent certain anemias; promote growth; assist in proper formation of bones and teeth; prevent scurvy; help proper bone formation; aid in prevention of rickets; help to prevent sterility and muscular dystrophy; and 502(f) (2)—the labeling of the article of Merci-Caps failed to warn that a physician should be consulted if the article was to be taken by children under 12 years of age; that a physician should be consulted if the article was taken for arthritis or rheumatism and pain persisted for more than 10 days, or if redness occurred; that, because of its content of powdered extract of belladonna, the article should not be used by elderly persons unless directed by a physician; that the article should not be used by persons having glaucoma or excessive pressure within the eye unless directed by a physician; and its labeling also failed to warn that the recommended dosage should not be exceeded and that the article was not for frequent or prolonged use. 6096. Niagara Thermo-Cyclopads and Hand Units. (F.D.C. No. 43587. S. No. 52-640 P.) QUANTITY: 10 cyclopads and 12 hand units at Minneapolis, Minn. SHIPPED: Between 8-14-59 and 8-28-59, from Adamsville, Pa. RESULTS OF INVESTIGATION: The Thermo-Cyclopad unit consisted of two separate parts: a cushioned pad containing an electric vibrating motor, and a heating element. The hand unit consisted of a vibrating electric motor within a lightweight tubular-shaped housing. LIBELED: 10-13-59, Dist. Min. CHARGE: 502(f) (1)—while held for sale, the labeling of the article failed to bear adequate directions for use as a treatment for relieving muscle spasms that surround the capillaries; relaxing spastic muscles through its penetrating action; improving circulation to allay aches and pains of all types of nervousness; relieving arthritis, bursitis, and rheumatism; for weight reducing, and to break down fatty cells in the body; giving health if used every day; and for use in polio centers and as hospital therapy equipment, which were the purposes and conditions for which the salesman, Clyde Dodd, orally offered the product at the Minnesota State Fair booth on 9-2-59. DISPOSITION: 11-25-59. Default-delivered to the Food and Drug Administration. DRUGS FOR VETERINARY USE 6097. Scour Stop for Pigs. (F.D.C. No. 43357. S. No. 62–815 P.) QUANTITY: 108 8-oz. plastic btls. at Chicago, Ill. SHIPPED: 2-2-59, from Kansas City, Mo., by Biolab. LABEL IN PART: "Scour Stop For Pigs *** Animal Drug Products, Inc., Chicago, Illinois *** Each Fluid Ounce Contains: Phthalyl-sulfacetamide 6 gr. Sulfathiazole 6 gr. Kaolin 36 gr. Pectin 2.4 gr. Bismuth Subcarbonate 3 gr." LIBELED: CHARGE: 8-24-59, N. Dist. Ill. (502(a)-when shipped, the label statements "Scour Stop For Pigs" and "For Treatment of Both Infectious and Non-Infectious Diarrhea in baby pigs" were false and misleading since the article was not an adequate and effective treatment for such conditions and purposes; 502 (b) (2)-the label of the article failed to bear a statement of the quantity of contents; and 502 (f) (1)—the labeling of the article failed to bear adequate directions for use. (The directions borne on the label "Holding bottle upside-down press out one teaspoonful of Scour-Stop to judge the amount of pressure needed to give this amount. By putting nozzle in pig's mouth administer one teaspoonful for each five pounds body weight." were inadequate since it was impossible to follow such directions and accurately measure out the recommended dosage to be administered to the pigs.) DISPOSITION: 9-22-59. Default-destruction. (F.D.C. No. 43565. S. Nos. 53-963/4 P.) 6098. Terephthalic acid. QUANTITY: 47 cases, each containing 10 bags, and 6 cases, each containing 10 tins, at Springdale, Ark. SHIPPED: Between 8-17-59 and 8-31-59, from Vineland, N.J., by Vinelard Poultry Laboratories. LABEL IN PART: (Bag) "Vineland Activator Solubilized Terephthalic Acid For Veterinary Use Only Caution: *** Net Contents 260 Grams [or tin "11⁄2 lbs."] Vineland Poultry Laboratories, Vineland, N.J. Los Angeles, Cal." RESULTS OF INVESTIGATION: The article was not subject to exemption from the requirement that its label bear adequate directions for use since it was not delivered for use only in the manufacture of a new drug limited to investigational use. Instead the article was used in the preparation of poultry feed which was sold on a straight commercial basis for use by poultry raisers of the area. LIBELED: 9-28-59, W. Dist. Ark. CHARGE: 502(f) (1)—when shipped, the label of the article failed to bear adequate directions for use. DISPOSITION: 12-12-59. Default-destruction. 6099. Terephthalic acid (Dupont TPA). (F.D.C. No. 43362. S. No. 57-127 P.) QUANTITY: 11 75-lb. drums at Gainesville, Ga. SHIPPED: 7-23-59 and 7-27-59, from Gibbstown, N.J., by E. I. du Pont de Nemours & Co. LABEL IN PART: "DuPont TPA Terephthalic Acid Technical Grade E. I. du Pont de Nemours & Co. Inc. Wilmington 98, Delaware Caution: Manufacturing, Processing or Repacking in the preparation of a New Drug is limited by federal law to investigational use. An effective new drug application will be required before a product containing this material may be marketed." RESULTS OF INVESTIGATION: Investigation showed that the article was to be used in the preparation of poultry feed which was sold on a straight commercial basis for use by poultry raisers; and therefore the article was not subject to the exemption afforded by the regulations from bearing adequate directions for use since the delivery was not made for use only in the manufacture of a new drug limited to investigational use. LIBELED: 8-25-59, N. Dist. Ga. CHARGE: 502(f) (1)—when shipped, the labeling of the article failed to bear adequate directions for use. DISPOSITION: 10-16-59. Default-destruction. DRUGS AND DEVICE ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS 6100. Terpin hydrate. DRUGS FOR HUMAN USE (F.D.C. No. 43797. S. No. 77-928 P.) QUANTITY: 2 25-lb. drums at Detroit, Mich. SHIPPED: 4-1-59, from Philadelphia, Pa., by Physicians Drug & Supply Co. RESULTS OF INVESTIGATION: Analysis showed that the article failed to comply with the National Formulary specifications for terpin hydrate in that it had an odor not permitted by the National Formulary. LIBELED: 11-10-59, E. Dist. Mich. CHARGE: 501(b)—when shipped, the quality and purity of the article fell below the standard for terpin hydrate set forth in the National Formulary. DISPOSITION: 12-7-59. Default-destruction. 6101. Contact lens wetting solution. (F.D.C. No. 43914. S. No. 70-347 P.) QUANTITY: 236 btls. at Philadelphia, Pa. SHIPPED: 84-59, from Wauconda, Ill., by Micon Laboratories. LABEL IN PART: "5 cc. Sample Mi-Con Wetting Solution *** Micon Laboratories, 905 Jackson Street, Wauconda, Ill. LIBELED: 11-13-59, E. Dist. Pa. CHARGE: 501 (c)-when shipped, the purity and quality of the article fell below that which it purported or was represented to possess since it purported to be suitable for use in the eye and for cleaning contact lenses, whereas, it was not suitable for such uses and purposes because it was contaminated with large numbers of viable micro-organisms. DISPOSITION: 12-16-59. Default-destruction. 6102. Obes-Ebb tablets and thyroid tablets. (F.D.C. No. 43330. S. Nos. 52887 P, 52-891 P, 53-565/6 P.) QUANTITY: 491 1,000-tablet btls. of Obes-Ebb tablets and 8 1,000-tablet btls. of thyroid tablets at Los Angeles, Calif. SHIPPED: 3-17-59 and 3-31-59, from Hoboken, N.J., by General Pharmacal Co., Inc. LABEL IN PART: "Green No. 1 Obes-Ebb *** Amphetamine Sulfate 10 Mgm. Thyroid 1 Gr., Aloin 4 Gr. Atropine Sulfate 1/360 Gr. * * * General Pharmacal Co. Hoboken, New Jersey *** 2619"; "Yellow No. 2 Obes-Ebb * * Thyroid 1 Gr., *** 2635"; "Brown No. 3 Obes-Ebb, Each Tablet Contains: Phenobarbital 4 Grain *** Thyroid 1 Grain *** 2636"; "FHJ Tablets Thyroid *** Contains 2 Grain Thyroid Powder USP *** F. H. J. Laboratories, Inc., New York, N.Y. Control 2637." RESULTS OF INVESTIGATION: Examination showed that the articles (all lots) contained less than the labeled amounts of thyroid. LIBELED: 84-59, S. Dist. Calif. CHARGE: 501(b)—when shipped, the strength of the thyroid tablets differed from, and their quality fell below, the standard for thyroid tablets set forth in the United States Pharmacopeia; 501(c)-the strength of the Obes-Ebb tablets differed from that which they purported and were represented to possess; and 502(a)—the label statements (Obes-Ebb tablets) "Each Tablet Contains Thyroid 1 Gr." and (thyroid tablets) "Contains 2 Grain Thyroid Powder USP" were false and misleading. 6103. Li-Folic-B12. (F.D.C. No. 43415. S. No. 76-043 P.) QUANTITY: 273 vials at St. Louis, Mo. SHIPPED: 3-9-59, from Dayton, Ohio, by Durr Products, Inc. |