Criminal Conviction of Vitamin Products Company
and Its President Royal Lee, D.D.S.
Royal Lee, D.D.S. a nonpracticing dentist who died in 1967, owned and operated the Vitamin Products Company, which sold food supplements, and the Lee Foundation for Nutritional Research, which distributed literature on nutrition and health. One of the vitamin company's products was Catalyn, a patent medicine composed of milk sugar, wheat starch, wheat bran, and other plant material. During the early 1930s, a shipment of Catalyn was seized by the FDA and destroyed by court order because it had been marketed with false claims of effectiveness against serious diseases. In 1945, the FTC ordered Lee and his company to discontinue illegal claims for Catalyn and other products. In 1956, the Post Office Department charged Lee's foundation with fraudulent promotion of a book called Diet Prevents Polio. The foundation agreed to discontinue the challenged claims. In 1962, Lee and the Vitamin Products Company were convicted of misbranding 115 special dietary products by making false claims for the treatment of more than 500 diseases and conditions. Lee received a one-year suspended prison term and was fined $7,000. In 1963, a prominent FDA official said Lee was "probably the largest publisher of unreliable and false nutritional information in the world."The document below is the summary of the 1962 conviction from the FDA's Notices of Judgment under the Federal Food, Drug and Cosmetic Act. The company, still family owned and operated, is now called Standard Process, Inc.
7203. C-Y. 1717 Vitamin. G, C-Y 1710A Cyroplex wafers, C-Y 1715 Vitamin E, Phosfood C-Y 1718, Cataplex A and C V-P 711-13 tablets, C-Y 1729, Cyruta wafers, and Cardiotrophin. (F.D.C. No. 44931. S. Nos. 49-098/99 P, 53-896 P, 61-901 P, 61-904 P, 68-066 P, 68-069 P.)
INFORMATION FILED: 9-28-60, E. Dist. Wis., against Vitamin Products Co., a corporation, and Royal Lee, president, Milwaukee, Wis.
SHIPPED: Between 11-24-58 and 9-10-59, from Milwaukee, Wis., to Oakland, Calif., Wayne, Pa., and St. Louis, Mo.
LABEL IN PART: (Btls.) "C-Y 1717 Vitamin G Content of. Vitamin factors for which standards have been established: Riboflavin . . . 1 mg. Niacin . . . 12 mg. * * * With synergists and extracts from yeast, sprouted grain and calf brain * * * Therapeutic Foods Co., Milwaukee, Wisconsin"; "C-Y 1710A Cyroplex: Concentrates from alfalfa, carrot, beef and fish liver lipoids, yeast, wheat germ, rice bran, liver, mushroom, green peas (whole plant), biologically processed corn. CARRIER MATERIAL: milk solids, wheat and oat flours. Each wafer contains 400 U.S.P. units Vitamin A, 10 U.S.P. units Vit. B1 20 U.S.P. units Vit. C, 100 U.S.P. units Vit. D, 25 Sherman Borquin units (60 gamma) Vit. G (ribo-flavin), 10 milligrams unsaturated fatty acids with naturally occurring associated factors * * * Therapeutic Foods Co., Milwaukee, Wisconsin; "C-Y 1715 Vitamin E Concentrates of Vitamin factors from the juice of green peas (whole plant), and natural mixed tocopherols (Vitamin E) obtained from vegetable oils . . . 1 mg. of Chlorophyll, and 35 mgs. of Ribonucleic Acid. Carrier Materials: Liver powder, wheat germ and lettuce * * * Therapeutic Foods Co., Milwaukee, Wisconsin"; "Phosfood C-Y 1718. Active Ingredients: Ortho-phosphoric acid, Phytin from cereal sources. Carrier Material: Raw sugar, corn starch, and gum Arabic * * * Therapeutic Foods Company, Milwaukee, Wisconsin"; "Cataplex A and C Vitamins A and C V-P 711-13. Each tablet contains 750 U.S.P. units of Vitamin A and 100 U.S.P. units of Vitamin C. with naturally associated vitamin and enzyme factors from Alfalfa, Carrot, Mushroom, Green Buckwheat Leaf, Bone Marrow, Beef Kidney and Fish Liver Lipoids. Carrier Materials: Rice Bran, Oat Flour, Fresh Bone Flour, and Anhydrous Honey * * * Vitamin Products Co., Milwaukee, Wisconsin"; "C-Y 1729 Cyruta Dehydrated extract of buckwheat seed and green leaf. Each wafer contains 90 mgm. inositol * * * Therapeutic Foods Co., Milwaukee, Wisconsin"; "Cardiotrophin Cytotrophic Extract of Beef Heart * * * Standard Process Laboratories, Milwaukee, Wisconsin Made in U.S.A."
ACCOMPANYING LABELING: Looseleaf folder entitled, on cover, "Therapeutic Foods Company:" and, on first page, "Doctor's Books An Introduction to Clinical Nutrition" and looseleaf folder entitled "Therapeutic Food Manual"; booklets entitled "Schedule of Recommendations for Specific conditions of Malnutrition" and "Applied Trophology * * * 1958, Volume 2—numbers 1-12"; looseleaf folders entitled "Issues on Relations of Vitamins to Heart Disease and "Vitamin News"; booklet entitled, on cover, "Standard Process Laboratories" and, on first page, "Protomorphogens Non-Vitamin Food Factors"; looseleaf folder entitled, on cover, "Vitamin Products Company" and, on first page, "Product Information for Doctors"; and looseleaf folder entitled, on cover, "Therapeutic Foods Company" and, on first page, "Product Information for Doctors."
CHARGE: 502(a)—when shipped, the labeling contained false and misleading representations that the articles were adequate and effective for the prevention and treatment of the following diseases and conditions:
C-Y 1717 Vitamin G—alopecia, Anders' disease, angina pectoris, asthma, astigmatism, biliary stasis, brain concussion, Buerger's disease, cancer, cataracts, cerebral hemorrhage, cerebral palsy, cerebral thrombosis, chorea, cirrhosis of the liver, conjunctivitis, coronary insufficiency, diabetic retinitis, diabetes mellitus, enlarged heart, epilepsy, fibroid tumors, gastric ulcers, heart block, herpes simplex, herpes zoster, hypertension, hypertrophy of the heart, liver diseases, mastitis, mitral stenosis, multiple sclerosis, nephritis, neuritis, neuromuscular disorders, nose polyps, osteoarthritis, Paget's disease, palsy, Parkinson's disease, pernicious anemia, prevention of heart disease, Raynaud's disease, rheumatoid arthritis, sciatica, shock, sterility, stroke, and varicose veins;
C-Y 1710A Cyroplex wafers—abortion, adrenal insufficiency, amenorrhea, ascites, brain concussion, brain dysfunction, brucellosis, Buerger's disease, bursitis, cancer, cataracts, cerebral palsy, chorea, cirrhosis of the liver, conjunctivitis, cryptorchism, cystitis, deafness, diabetes mellitus, disc lesions, Dupuytren's disease, emphysema, endocervicitis, epilepsy, febrile diseases, fibroid tumors, gallbladder diseases, gastric ulcers, gingivitis, goiter, gout, gynecomastia, heart diseases and conditions, hemorrhoids, hernia, herpes simplex, herpes zoster; hypertension, hyperthyroidism, hypotension, intestinal worms, leg ulcers, leukopenia, leukoplakia, lymph node infections, malaria, mastitis, mucous colitis, multiple sclerosis, muscular dystrophy, myasthenia gravis, myocarditis, myositis ossificans, nephritis, osteoarthritis, palsy, Peyronie's disease, phlebitis, poliomyelitis, prostate disease, rheumatic fever, sciatica, shock, sinusitis, strictures, stroke, telangiectasis, tonsillitis, tuberculosis, varicose veins, Vincent's infection, and virus infections;
C-Y 1715 Vitamin E—abortion, acne, acute and subacute vascular obstructions, acute glomerulonephritis, arteriosclerosis, atrophic arthritis, Bell's palsy, Buerger's disease, bursitis, cancer, coronary occlusion, coronary thrombosis, Dupuytren's contracture, diabetes mellitus, exfoliative dermatitis, febrile diseases, fibroid tumors, gastric ulcers, grippe, heart failure, hernia, herpes zoster, influenza, leukoplakia, multiple sclerosis, muscular atrophy, muscular dystrophy, myocardial degeneration, neuritis, paralysis of young, peripheral thrombosis, Peyronie's disease, phlebitis, prevention of heart disease, sinusitis, sterility, Sydenham's chorea, thromboangiitis obliterans, thrombocytopenia, thrombophlebitis, urethral stricture, and varicose veins;
Phosfood C-Y 1718—Buerger's disease, bursitis, cataracts, cerebral apoplexy, deafness, diabetic ulcers, diarrhea, emphysema, gastric ulcers, gallbladder diseases, glaucoma, hyperthroidism, hypertension, hypotension, heart diseases and conditions (coronary disease, angina pectoris, bradycardia, myocarditis), kidney stones, leukocytosis, leukopenia, neuritis, osteoarthritis, phlebitis, varicose ulcers, and varicose veins;
Cataplex A and C V-P 711-13 tablets—angina pectoris, asthma, Buerger's disease, bronchitis, bursitis, cerebral hemorrhage, cataracts, fibroid tumors, glaucoma, glomerulonephritis, gastric ulcers, heart diseases. and conditions (bacterial endocarditis, stenosis due to scars from rheumatic fever), hypertension, influenza, leukopenia, Meniere's disease, mumps, nose polyps, nephritis, osteoarthritis, osteoporosis, ovarian tumors, Paget's disease, phlebitis, pyorrhea, rheumatic fever, staphylococcus infections, streptococcus infections, undulant fever, varicose veins, and Vincent's infection;
C-Y 1729 Cyruta wafers—Anders' disease, arteriosclerosis, blurred vision, cancer, cataracts, cirrhosis of the liver, diabetic retinitis, diabetes mellitus, erysipelas, glaucoma, gastric ulcers, hypertension, malignant hypertension, Paget's disease, prostate hypertrophy, paroxysmal tachycardia, and rheumatoid arthritis;
Cardiotrophin—adrenal insufficiency, all forms of heart disease, arteriosclerosis, asthma, diabetes mellitus, and hernia.
PLEA: Nolo contendere by Vitamin Products Co., to the counts involving all of the above-mentioned products and' by Royal Lee to the counts involving C-Y 1717 Vitamin G and C-¥ 1710A Cyroplex wafers.
DISPOSITION: 4-23-62. Royal Lee—imprisonment for 1 year (suspended), and probation for 3 years; Vitamin Products Co.—$7,000 fine.
This page was posted on April 16, 2006.