CHARGE: 501 (c)-when shipped, the quality of the article fell below that which it purported and was represented to possess, namely, .05 percent sulfaquinoxaline; and 502(a)—the label statement "Sulfaquinoxaline .05%" was false and misleading. DISPOSITION: 5-6-60. Default-delivered to a Federal institution for use as animal feed. DRUGS AND DEVICE ACTIONABLE BECAUSE OF FALSE AND DRUGS FOR HUMAN USE* 6184. Organic mineral salt. (F.D.C. No. 43685. S. No. 35–469 P.) INFORMATION FILED: 12-29-59, S. Dist. Calif., against Dr. E. H. Bronner & Associates, a partnership, Los Angeles, Calif., and Emanuel H. Bronner, part ner. SHIPPED: 3-14–58, from California to Pennsylvania. ACCOMPANYING LABELING: Leaflet entitled "Organic Mineral Salt & Bouillon." CHARGE: 502(a)—when shipped, the labeling of the article contained false and misleading representations that the article would be adequate and effective for the stopping of tooth decay. PLEA: Guilty. DISPOSITION: 3-21-60. Partnership-$1,000 fine suspended; individual-1 year in prison suspended, and probation for 2 years. 6185. Slim-Time reducing capsules. (F.D.C. No. 44084. S. No. 86–633 P.) QUANTITY: 360 30-capsule boxes and 720 14-capsule boxes at Buffalo, N.Y. SHIPPED: 7-13-59, from Dallas, Tex., by Preston National Drug Co. LABEL IN PART: (Box front) "Slim-Time Disintegrating Reducing Capsules Each Capsule Contains 75 mgm. Phenyl Propanolamine Hydrochloride in a special timed disintegration base that provides for prolonged effect for about 6 to 10 hours *** Distributed by Herculex Drug Co., Inc. Buffalo, New York." ACCOMPANYING LABELING: Insert leaflet entitled "Eat What You Like, But." LIBELED: 3-10-60, W. Dist. N.Y. CHARGE: 502(a)—when shipped, the name and the labeling of the article contained false and misleading representations that the article was effective for reducing weight and for treatment of obesity without rigid diets. DISPOSITION: 4-13-60. Default-destruction. 6186. Vitamin E capsules. (F.D.C. No. 44253. S. No. 77-340 P.) QUANTITY: 203 100-capsule btls. at Seattle, Wash., in possession of Pay'n Save Drug. SHIPPED: Between 7-30-59 and 12-4-59, from Portland, Oreg. See also Nos. 6163, 6165, 6167, 6169-6173, 6175-6183. LABEL IN PART: "Pioneer *** List No. 51 [or "53"] Vitamin 'E' Vita min E capsules contain: d-alpha tocopheryl Acetate Conc. NF equivalent to 50 [or "100"] International Units Vitamin E." ACCOMPANYING LABELING: Newspaper tear sheets from the Seattle Times, Wednesday, January 13, 1960. CHARGE: 502 (a)—while held for sale, the label statement "The Need for vitamin E in human nutrition has not been established" was false and misleading and the labeling which accompanied the article contained false and misleading representations that the article was adequate and effective for the prevention of problems during menopause and persistent skin ulcers. DISPOSITION: 44-60. Default-destruction. 6187. Blake geriatric formula. (F.D.C. No. 44088. S. No. 96–386 P.) QUANTITY: 90 individually cartoned 100-capsule btls. at Marshalltown, Iowa, in possession of Osco Drug. SHIPPED: Between 1-11-59 and 1-16-59, from Allegan, Mich., by L. Perrigo Co. LABEL IN PART: "Capsules Blake Hi-Potency Geriatric Formula Plus B-12, Blake Pharmacal Co., Allegan, Mich." ACCOMPANYING LABELING: Newspaper tear sheets and placards reading in part “Blake Hi-Potency Geriatric Formula” and signs reading in part “Combat Colds! Build Resistance with Vitamins." LIBELED: 3-15-60, S. Dist. Iowa. CHARGE: 502 (a)—when shipped and while held for sale, the name and the labeling which accompanied the article contained false and misleading representations that it was adequate and effective to promote health and vitality; prevent premature aging; maintain youthful pep, energy and spirit; and develop resistance to disease. DISPOSITION: 4-14-60. Default-destruction. 6188. Nasal inhalant. (F.D.C. No. 44366. S. No. 90–965 P.) QUANTITY: 282 counter cards, each containing 1 individually cartoned 30-cc. btl., at Boston, Mass. SHIPPED: 1-25-60, from Trenton, N.J., by Astron Chemicals & Pharmaceuticals, Inc., New York, N.Y. LABEL IN PART: (Ctn.) "Instantly Nasal Inhalant * * Ingredients: Alcohol 25%, Chloroform 9 min. per. fl. oz., Oil of camphor, Eucalyptol, Menthol, Camphor. Astron Chemicals and Pharmaceuticals, Inc. New York 18, N.Y." ACCOMPANYING LABELING: Card entitled "Not a nose drop! Not a spray!" and leaflet in carton entitled "Instantly The Modern Nasal Decongestant." LIBELED: 3-7-60, Dist. Mass. 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 sinus congestion and nasal congestion due to colds, hay fever. and allergies. DISPOSITION: 4-25-60. Default-destruction. 6189. Dex-A-Diet tablets. (F.D.C. No. 44074. S. No. 42-935 P.) QUANTITY: 20 21-tablet btls. and 12 100-tablet btls. at Denver, Colo. SHIPPED: 1-22-60, from Detroit, Mich., by Alpha Tablets Co. LABEL IN PART: "Dex-A-Diet A True Appetite Depressant Packaged by CHARGE: 502 (a)—when shipped, the labeling which accompanied the article contained false and misleading representations that the article was adequate and effective as an appetite depressant and in the management and treatment of obesity. DISPOSITION: 4-21-60. Default-destruction. 6190. Gelatin Slim capsules. (F.D.C. No. 44233. S. No. 93–168 P.) QUANTITY: 7 30-capsule boxes, 11 at Seattle, Wash. 90-capsule boxes, and 5 201-capsule boxes SHIPPED: Between 7-27-59 and 10-28-59, from Santa Monica, Calif., by Gelatin Plus, Inc. LABEL IN PART: (Insert label) "Ten Gr. Capsules Gelatin Slim A Dietary Supplement The modern aid to figure beauty Each capsule contains 445 mg. of pure high protein sugarless gelatin and 182 mg. of true citrus cellulose *** Distributed by Gelatin-Plus, Santa Monica, Calif." ACCOMPANYING LABELING: Leaflet in box entitled "Gelatin Slim." CHARGE: 502(a)-when shipped and while held for sale, the labeling of the article contained false and misleading representations that it was adequate and effective for curbing the appetite; for weight reduction without rigid diets; that it would build firm healthy tissues and help one to look and feel younger and more attractive; and that use of the article would produce "figure beauty." DISPOSITION: 4-4-60. Default-destruction. 6191. Slippery elm food, dandelion essence, and roasted dandelion root. (F.D.C. No. 44224. S. Nos. 42-288 P, 42-292/3 P.) QUANTITY: 9 1-lb. tins of slippery elm food, 48 of dandelion essence, and 42 4-lb. tins and 13 root, at Seattle, Wash. 4-oz. btls. and 35 8-oz. btls. 1⁄2-lb. tins of roasted dandelion SHIPPED: Between 7-18-59 and December 1959, from Covington, Ky., by Dandelions Unlimited (Irene E. Barbasch). LABEL IN PART: "Thompson's Slippery Elm Food * **Contains: Precooked Wheaten Flour, Powdered Slippery Elm Bark and Sugar Unmalted Sole Proprietors Potter & Clarke, Ltd."; "Prepared from pure Dandelion Root Thompson's Dandelion Essence *** Sole Proprietors Potter & Clarke, Ltd. * Sole Importer and Distributor for U.S.A. Irene E. Barbasch * * Covington, Kentucky"; and "Thompson's Roasted Dandelion Root *** Product of England * ** Irene E. Barbasch***Covington, Kentucky." ACCOMPANYING LABELING: Leaflets entitled "The Story of Thompson's Slippery Elm Food and Its Value to You" and "Dandelions & You." LIBELED: 2-5--60, W. Dist. Wash. CHARGE: 502(a)-when shipped, the accompanying labeling of the articles contained false and misleading representations that the slippery elm food was an adequate and effective treatment for inducing sleep; managing ulcerative conditions and mucous colitis; providing healing properties; restoring and maintaining health; and overcoming frayed nerves; digestive disorders; inflammation, dysentery, diarrhea, and urinary troubles; and that the dandelion essence and roasted dandelion root were an adequate and effective treatment for stimulating the liver and kidneys to improve elimination; cleansing the bloodstream, to aid in eliminating toxins and other impurities from the system; and for making eyes and complexion clearer and for removing pimples. DISPOSITION: 5-31-60. Default-destruction. 6192. Kanker Komfort. (F.D.C. No. 44108. S. No. 28-707 R.) QUANTITY: 10 1-gal. glass jugs and 249 vials at Duluth, Minn., in possession of Oral Prophylactic Association, Inc. SHIPPED: 8-24-59, from Lafayette, Ind. LABEL IN PART: (Jug) "Control Number 29831 Date 8-6-59 Prepared for Oral Prophylactic Ass'n., Duluth, Minnesota *** Each Fluid Ounce Represents Pectin 111⁄2 grs. Bismuth Sodium Tartrate 72 grs. Lafayette, Indiana" and (vial) “Kanker Komfort for Cankers, cold sores, denture abrasions. minor mouth lacerations, Cont. 3 Fluid Drams * * * Manufactured for Oral Prophylactic Association, Inc., Duluth, Minn." RESULTS OF INVESTIGATION: The article in the vials was repacked and relabeled from the jugs which had been shipped as described above. LIBELED: 3-30-60. Dist. Minn. CHARGE: 502 (a)—while held for sale, the name and the label of the article contained false and misleading representations that it was an adequate and effective treatment for cankers, cold sores, denture abrasions, and minor mouth lacerations. DISPOSITION: 5-6-60. Consent-claimed by Oral Prophylactic Association, Inc., and relabeled. 6193. Stimavite Tastitabs. (F.D.C. No. 44380. S. No. 91-021 P.) QUANTITY: 53 individually cartoned btls. at Taunton, Mass. SHIPPED: Prior to March 1957, from Chicago, Ill., by J. B. Roerig & Co., Div. Chas. Pfizer & Co., Inc. LABEL IN PART: (Btl. & ctn.) "No. 2841 Stimavite Tastitabs *** J. B. Roerig and Company, Chicago 11, Illinois, Division Chas. Pfizer & Co., Inc. Each tablet contains: Vitamin B-12 20 mcg. Vitamin B-6 3 mg. Vitamin B-1 10 mg. Vitamin C (as sodium ascorbate) 25 mg. Lysine 15 mg. Lot No. 64108." CHARGE: 502(a)—when shipped, the label statement "Appetite stimulant for children containing Lysine to promote proper growth” was false and misleading since the article was not adequate and effective for such purposes. The libel alleged also that a number of articles were adulterated and misbranded under the provisions of the law applicable to foods as reported in notices of judgment on foods. DISPOSITION: 5-16-60. Default-destruction. 6194. Vege-Whey. (F.D.C. No. 44378. S. No. 93–225 P.) QUANTITY: 115 16-oz. jars, 14 3-lb. jars, and 5 5-lb. jars, at Seattle, Wash. SHIPPED: Between 1-27-59 and 11-9-59, from Los Angeles, Calif., by Vegetrates Co. LABEL IN PART: (Jar) "Swiss Type Vege-Whey*** Dairy-Fresh Whey Dehydrated to make a Rich, Concentrated, Wholesome Beverage Made Only From Certified Raw Milk. Analysis: Lactose: Approximately 70%, a nutritious, nourishing, easily-digested sugar. Protein: Approximately 12%, Contains those proteins natural to milk. Vege-Whey: Contains easily assimilable calcium and phosphorus from milk. *** Distributed by Vegetrates Company, Los Angeles, Calif." ACCOMPANYING LABELING: Leaflets entitled "Avoid Intestinal Putrefaction" and placards reading in part "Are You Troubled With Intestinal Toxemia? Swiss Type Vege-Whey." LIBELED: 3-21-60, W. Dist. Wash. CHARGE: 502(a)—the labeling accompanying the article, when shipped, contained false and misleading representations that it was an adequate and effective treatment for intestinal toxemia, intestinal disorders due to putrefactive flora, and to combat stagnation of the intestines, retard putrefaction, and promote free, natural laxation. DISPOSITION: 5-31-60. Default-destruction. 6195. VitaWell Anti-Cholesterol tablets. (F.D.C. No. 44388. S. No, 80-078 P.) QUANTITY: 237 100-tablet btls. and 35 250-tablet btls. at Harbert, Mich. SHIPPED: November 1958, from Inwood, N.Y., by Barrows Chemical Co., Inc. LABEL IN PART: (Btl.) "VitaWell Natural Organic Anti Cholesterol Tablets A rich dietary supplement providing the natural occurring lipotropic factors in high potencies as occurring in soy-bean lecithin, coupled with rice bran concentrate, unsaturated fatty acids, and vitamin B-12 activity. Daily Dosage of Six Tablets Contains: Soy Bean Lecithin 1200 mg. Providing: Choline Phosphatidyl 400 mg. Providing: Inositol Containing Phosphatides 400 mg. Rice Bran Concentrate 120 mg. Unsaturated Fatty Acids (Principally Linoleic) 180 mg. Vitamin B12 Activity (cobalamin concentrate) 4.5 mcg. Distributed by Vita Well Products Co., Harbert, Mich." ACCOMPANYING LABELING: Catalogs entitled "Catalog of Vita Well Vitamins" which were printed on order of Vita Well Products Co. LIBELED: 3-23-60, W. Dist. Mich. CHARGE: 502 (a)-when shipped and while held for sale, the name of the article "Anti-Cholesterol Tablets," and statements in its labeling, namely, bottle label and catalog entitled "Catalog of Vita Well Vitamins," contained false and misleading representations and suggestions that the article was adequate and effective for the prevention of the accumulation of cholesterol in the blood vessels; heart disease; hardening of the arteries; clogging of blood vessels; and strokes. DISPOSITION: 5-6-60. Default-destruction. 6196. Arman's Nail-Kare Gelatin capsules, Arman's Kurbatine Chewing Gum tablets, and Arman's Stoma-Kons tablets. (F.D.C. No. 43542. S. Nos. 22-523/5 P.) QUANTITY: 512 36-capsule btls. of Arman's Nail-Kare, 519 20-tablet btls. of Arman's Kurbatine Chewing Gum, and 358 50-tablet btls. of Arman's StomaKons, at Omaha, Nebr., in possession of Arman Drug Co., Inc. |