DRUGS AND DEVICES ACTIONABLE BECAUSE OF FALSE AND MISLEADING CLAIMS DRUGS FOR HUMAN USE⚫ 5632. Soy lecithin. (F.D.C. No. 41514. S. No. 41-406 P.) QUANTITY: 1 60-lb. drum and 11 12-lb. btls. at Parma, Idaho, in possession of Arthur E. Yensen, t/a Yensen Mineral Co. SHIPPED: 1-9-58, from Portland, Oreg. LABEL IN PART: (Btl.) "1⁄2 Pound (one month's supply) Granular Lecithin *** One level teaspoonful with each morning and evening meal, or as your doctor directs *** Distributed by Yensen Mineral Company, Parma, Idaho." ACCOMPANYING LABELING: Leaflets identified as "Lecithin and Health Compiled from recent literature by: Arthur E. Yensen." RESULTS OF INVESTIGATION: The article in the btls. was repackaged by the dealer from the above-mentioned bulk drum, and the leaflets were printed locally for use by the dealer in promoting the sale of the article. LIBELED: 4-16-58, Dist. Idaho. CHARGE: 502(a)—the labeling accompanying the article, while held for sale, contained false and misleading respresentations that the article was effective for overcoming hardening of the arteries, anemia, high blood pressure, coronary thrombosis, arthritis, diabetes, liver conditions, prostate troubles, "brain fag," nervousness, emotional irritability, headache, insomnia, and improving the general health of older people. 5633. Soy and wheat germ oil concentrate and Energol germ oil concentrate. (F.D.C. No. 41518. S. Nos. 38-891/2 P.) QUANTITY: 5 8-oz. btls. of soy and wheat germ oil concentrate, and 11 16-oz. and 5 32-oz. cans of Energol germ oil concentrate at San Francisco, Calif. SHIPPED: 11-25-57 and 1-30-58, from York, Pa., by York Barbell Co. LABEL IN PArt: (Btl.) "Hoffman's Soy Germ Oil Wheat Germ Oil Concentrate" and (can) "Hoffman's Energol Germ Oil Concentrate." ACCOMPANYING LABELING: Leaflets entitled "Hoffman's Germ Oil Concentrate" and "Test Taste Compare Hoffman's High Protein Food Products." LIBELED: 4-21-58, N. Dist. Calif. CHARGE: 502(a)-when shipped, the labeling of the articles contained false and misleading representations that the need in human nutrition for linoleic acid, choline, inositol, and vitamin E, contained in the articles, was recognized and established; that the use of the articles would insure a hormone balance in the body and build enzymes, would give one health, strength, and endurance; and would be effective in preventing or treating physical or sexual weakness, arteriosclerosis, coronary thrombosis, eczema, Buerger's disease, gallstones cell production, cirrhosis of the liver, gangrene, sore tongues, nervousness, anemia, epilepsy, difficulty in walking, pathological changes in the liver, thyroid and sex glands, inflamation of the intestines, extreme fatigue, oil secretion in eyelashes, bloodshot lip, swelling under eyes, quarrelsomeness, mental sluggishness, numbness, low blood pressure, shortage of breath, severe headaches, gas pains, flatulence, insufficient gastric juices, lack of hydro•See also Nos. 5621, 5624-5630. chloric acid, shingles, arthritis, alcoholism, underactive pituitary glands, waddling gait, unusual sensitivity to pain, changes in the bone marrow, changes in the nodes, lack of fertility, changes in the nerves, stunted growth, middle age spread, premature aging, overweight, stimulation of bile, coronary thrombosis, heart attacks, sore mouths, mental depression, insomnia, dizziness, irritability, tremors, nervous tics, blackouts, cataracts, tongue abnormalities, watery eyes, inefficiency, depression, sensitivity to noise, low basic metabolism, enlarged heart, vomiting, muscular contraction of the stomach, headache, diarrhea, trifacial neuralgia, sciatica, rheumatism, irregular menstruation, lack of strength, skin lesions, emaciation, sexual disturbances, coco pigmentation, changes in the brain cells, lagging secondary sex characteristics, swelling of the feet and ankles, inactive ovaries, muscular and joint stiffness, diabetes, gangreneous ulcers, coronary occlusion, premature old age, sore lips, menstrual irregularities, extreme weakness, nausea, convulsions, paralysis, tension, duodenal ulcers, adrenal deficiency, aching feet, neuritis, bloodshot eyes, early menopause, weak eyes, burning eyes, forgetfulness, constipation, high blood pressure, heart palpitation, pain in muscles, low energy production, sick stomach, heart abnormalities, severe headaches, lumbago, premature aging, premature menopause, lack of co-ordination, eye infection, ear infec tions, changes in the lymph, changes in the spleen, too rapid growth, edema, muscular distrophy, and strains. DISPOSITION: 2-27-59. Default-5 btls. of the soy and wheat germ oil con centrate and 10 copies, each, of the accompanying leaflets were delivered to the Food and Drug Administration, and the remainder of the articles was destroyed. 5634. Honey with royal jelly and royal jelly capsules. 3-870/3 P.) (F.D.C. No. 41504. S. Nos. QUANTITY: 18 1-lb. 4-oz. jars of honey with royal jelly, and 27 15-capsule btls., and 2 boxes, each containing 1 15-capsule vial of royal jelly, at Baltimore, Md., in possession of Special Diet Shop, Inc. SHIPPED: Between 11-21-57 and 1-23-58, from New York, N.Y. ACCOMPANYING LABELING: Posters entitled "Reprints of Scientific News Reports on Royal Jelly" and "Royal Jelly Universally Acclaimed." RESULTS OF INVESTIGATION: The posters were used by the dealer for promotion purposes as part of a window display of the article. LIBELED: 4-7-58, Dist. Md. CHARGE: 502(a)-the labeling accompanying the articles, while held for sale, contained false and misleading representations that the articles would aid in the cure of cancer, prevent aging, would be efficacious in many physical ailments useful in treating premature, undernourished, and diseased infants, would successfully treat arthritis, leukemia, and ulcers, and restore vitality. DISPOSITION: 5-21-58. Default-destruction. 5635. Royal jelly capsules with vitamins and royal jelly cream. (F.D.C. No. 41515. S. Nos. 3-543/6 P.) QUANTITY: 1 canister containing 175 capsules, 1 canister containing 1,050 capsules, 1 canister containing 1,450 capsules, and 1 150-capsule btl., 10 100-capsule btls., 3 50-capsule btls., and 6 30-capsule btls., of royal jelly with vitamins, and 286 jars of royal jelly cream, at Washington, D.C., in possession of Tipton & Myers. SHIPPED: 3-15-58 and 3-17-58, from Brooklyn, N.Y., and Newark, N.J. tributors Nt. Wt. Two Ozs." ACCOMPANYING LABELING: Window display and counter cards entitled "Royal Jelly New Miracle Aid," "Royal Jelly: New Miracle Aid *** On a Sunny April Morning," "More About Royal Jelly," and "Royal Jelly The Queen Bee's Secret Food of Vitality and Long Life." RESULTS OF INVESTIGATION: The capsules in the btls. had been shipped in the above-mentioned canisters, as described, and upon receipt by the consignee were repackaged and relabeled. The window display and counter cards were photographs of portions of an article on royal jelly that appeared in the December 1957 and January 1958 issues of Popular Medicine. The window display and counter cards were prepared locally by the consignee. LIBELED: 4-9-58, Dist. Columbia. CHARGE: 502(a)—the labeling accompanying the articles, while held for sale, contained false and misleading representations that the articles would produce a sense of well being, give one pep and vitality, increase vigor, regenerate flagging sex drive, reinforce cells in the human body, halt mental depression, act as a tranquilizer, stop stomach upsets, lengthen life, revitalize sex drive, strengthen cells, restore sagging breasts, and cure a wide range of illnesses from neurasthenia to arthritis. DISPOSITION: 5-23-58. Default-delivered to a public institution for its use, and not for sale. 5636. Honey with royal jelly and royal jelly capsules. (F.D.C. No. 41652. S. Nos. 84-444/5 P.) QUANTITY: 36 jars of honey with royal jelly and 3 btls. of royal jelly capsules at Erie, Pa., in possession of Dietetic Food Co. SHIPPED: The honey with royal jelly was shipped on 8-19-57, from Los Angeles, Calif., and the royal jelly capsules were shipped on 3-4-58 from Chicago, Ill. LABEL IN PART: (Jar) “Honey With Royal Jelly * * * Net Wt. 1 Lb. 4 Oz. Contains About 3800 Mgs. of Pure Royal Jelly"; (btl.) "Royal Jelly— 60 Mg. 50 Capsules." ACCOMPANYING LABELING: Leaflet entitled "You Must Read These Facts." RESULTS OF INVESTIGATION: The above-mentioned leaflets were printed locally. LIBELED: 4-9-58, W. Dist. Pa. CHARGE: 502(a)—the labeling accompanying the articles, while held for sale, contained false and misleading representations that each article “rejuvenates failing or worn out glands, producing a feeling of youthfulness," "eliminates chronic tiredness," "produces general state of wellbeing," "permits prolonged intellectual work without tiring," "normalizes growth of underdeveloped children," "gives fast, effective relief to women suffering critical years," and "stimulates appetite and lengthens lives." 5637. Desert bath minerals. (F.D.C. No. 41506. S. No. 39-551 P.) QUANTITY: 376 ctns. at Sacramento, Calif., in possession of Desert Products Distributing Co. SHIPPED: 8-6-57, from Sparks, Nev., by Desert Minerals Co. LABEL IN PART: "Desert Bath Minerals *** Approximate chemical composition (parts per million): Silica * * * 55.2, Iron *** Trace, Manganese 0., Calcium *** 176.1, Magnesium *** 1.5, Sodium *** 325.0, Potas sium *** 4.1, Bicarbonate *** 27.5, Sulphate *** 360.4, Chloride 287.2, Fluoride *** 0., Nitrate *** 0., Alumnia *** 2.4, Copper Trace. Mined, Packed and Sold by Desert Minerals Company Nevada Net Weight 20 Ounces." Sparks, ACCOMPANYING LABELING: Booklet entitled "The Discovery of Fabulous Desert Bath Minerals," folder entitled "Good News," letterheads of "Desert Products Distributing Company," and posters reading in part "Arthritis-RheumatismIrregularity Nature's Way Thru Desert Bath Minerals." RESULTS OF INVESTIGATION: The booklet was enclosed in the ctns. containing the article. The folder was printed in Sacramento for the shipper and delivered by the shipper to the dealer, and the letterheads and posters were printed on order of the dealer. LIBELED: 4-14-58, N. Dist. Calif. CHARGE: 502 (a)—when shipped and while held for sale, the ctn. label and the accompanying labeling of the article contained false and misleading representations that the article was "live" organic, medicinal agents of health and beauty beneficial in mineral-hungry conditions, and is an adequate and effective treatment for arthritis, gout, rheumatism, metallic poisoning, many skin diseases, catarrhal conditions, sinus irregularity, backache, kidney trouble, chronic diarrhea, uric acid gravel and calculi, syphilis, and hyperemia of liver. DISPOSITION: 6-12-58. Default-destruction. 5638. Dynamic vibrator. (F.D.C. No. 41532. S. No. 30-181 P.) QUANTITY: 24 devices at Newark, N.J., in possession of Renhill Products Co. RESULTS OF INVESTIGATION: The leaflets entitled "There's New Body Beauty” were prepared and printed at Newark, N.J., on order of the dealer, and the other leaflets were obtained by the dealer from the shipper of the device, Examination of the device revealed that it was a vibrator powered by a single electric motor fitted with an elongated commutator shaft, eccentrically weighted to cause the motor to vibrate. The motor was contained within a small plywood box which was wrapped with a sponge-like plastic cushioning material covered with Duran plastic. LIBELED: 5-2-58, Dist. N.J. CHARGE: 502(a)—the labeling accompanying the article, when shipped and while held for sale, contained false and misleading representations that the article was an adequate and effective treatment for stimulating blood circulation, relaxing nervous tension, increasing body nutrition, improving general metabolism, relieving simple constipation, reducing the figure, decreasing fatigue, relieving aches and pains from arthritis, rheumatism, lumbago, and bursitis, overcoming fibrositis, breaking down excess fatty tissue, overcoming muscular ailments, providing pep, vitality, comfort, and happiness, and being of value as a general body conditioner. 5639. Jacuzzi whirlpool bath device. (F.D.C. No. 41574. S. No. 18-428 P.) QUANTITY: 17 devices, at Denver, Colo. SHIPPED: Between 8-8-57 and 5-7-58, from Berkeley, Calif., by Jacuzzi Bros., Inc. ACCOMPANYING LABELING: Brochures entitled "Jacuzzi Whirlpool Bath," "The Whole Family Loves Jacuzzi Whirlpool Bath," and "Jacuzzi Whirlpool Bath For Professional Use Only," and posters designated "Feel Good Again In Your Own Bathtub," "P-G and E Progress," and "The Whole Family Loves the Jacuzzi Whirlpool Bath." RESULTS OF INVESTIGATION: Examination showed that the device had an enclosed electric motor which would drive a water pump. The water was forcefully driven through a nozzle and air aspirator, thus producing a swirling airwater foam. LIBELED: 5-28-58, Dist. Colo. CHARGE: 502(a)—the labeling accompanying the article, when shipped, contained false and misleading representations that the article was an adequate and effective treatment for arthritis, rheumatism, bursitis, and nagging backache, providing passive exercise, beauty treatment, postpolio rehabilitation, and sparkling radiant complexion, preventing accumulation of soft, fatty tissues, varicose veins, and sagging muscles, toning muscles and firming tissues, adding years to one's life and keeping one free of old age miseries, keeping one slim and trim and making the daily bath become a "fountain of youth," washing away worry lines, attaining figure and vital complexion control, improving circulation, and keeping robust and virile. DISPOSITION: 5-8-59. Consent-claimed by Jacuzzi Brothers, Inc., and relabeled. DRUG FOR VETERINARY USE 5640. Poultry mixtures and poultry and livestock mixture. (F.D.C. No. 41523. S. Nos. 27-927/30 P.) QUANTITY: 229 1-gal. jugs, 167 1-qt. btls., and 614 1-pt. btls., of poultry and livestock mixture, and 26 1-lb. 6-oz. pkgs. of poultry mixtures at New Orleans, La. SHIPPED: 2-1-58, from Grand Bay, Ala., by Marguerite Newman. LABEL IN PART: (Containers) "Ladner's Improved Poultry and Livestock Mixture *** Contents: Magnesium Sulphate, Calcium Hydroxide, Sulphur, Farrous Sulphate, Oil of Turpentine and Nicotine. Inert: 60%" and "Ladner's Improved Poultry Mixtures *** Contents: Epsom Salts 11.96 per cent Commercial Sulphur 11.11 per cent Slacked Lime 68.00 per cent Iron Hydroxide 7.68 per cent Acid Insoluble Residue 1.95 per cent." |