13481. Misbranding of Hyland's Natural B Complex Tablets. U. S. v. Standard Homeopathic Co. Plea of guilty. Fine, $300. (F. D. C. No. 22071. Sam- ple No. 31283-H.) INFORMATION FILED : September 25,1947, Southern District of California, against the Standard Homeopathic Co., a corporation, Los Angeles, Calif. INTERSTATE SHIPMENT:- On or about June 18, 1945, from Cincinnati, Ohio to Los Angeles, Calif. LABEL, WHEN SHIPPED: "Tablets Special Formula S1414 Each tablet repre- sents: Thiamine (Bi) . . . 55 U. S. P. Units Vitamin D ... 100 U. S. P. Units Riboflavin (G) . . . 0.166 mg. Pyridoxine (B8) . . . 0.28 mg. Pan- tothenic Acid . . . 0.083 mg. Niacin . . . 0.166 mg together with all other members of the Vitamin B Complex natural to yeast. Alfalfa . . . 0.325 Gm. (For Repackaging Purposes Only) John T. Lloyd Laboratories, Inc. 1414 Cin- cinnati, Ohio." ALLEGED VIOLATION : Between June 30,1945, and August 1,1946, while the tablets were being held for sale after shipment in interstate commerce, the defendant caused a number of the tablets to be removed from the container in which they had been shipped, repacked them into bottles, and caused a number of circulars and placards to be displayed and placed in proximity to the re- packaged tablets, which acts of the defendant resulted in the tablets being misbranded. The repackaged tablets were labeled in part "Hyland's Natural B Complex Tablets." The circulars were headed "Lack of . . . Vitamin B Complex May Cause," and the placards were entitled "Deficiency of Vitamin B2," "Deficiency of Vitamin D," "Deficiency of Vitamin Bi," "Deficiency of Vitamin A," "Deficiency of Vitamin Calcium Pantothenate," "Deficiency of Vitamin Nicotinic Acid," and "Deficiency of Vitamin C." NATURE OF CHARGE: Misbranding, Section 403 (a), the following statements on the label of the repackaged tablets were false and misleading: "Alfalfa 0.325 Gm. together with all the other members of the Vitamin B Complex natural to yeast * * * With the object of more natural vitamin fortification, natural yeast and alfalfa have been utilized" and "Requirements for Pyri- doxine, Pantothenic Acid * * * have not been determined." These state- ments represented and suggested that the tablets contained nutritionally significant amounts of alfalfa and yeast and that the need for pyridoxine and pantothenic acid in. human nutrition has been established, whereas the tablets did not contain nutritionally significant amounts of alfalfa and yeast and the need for pyridoxine and pantothenic acid in human nutrition has not been established. Further misbranding, Section 403 (j), the repackaged tablets purported to be, and were represented for special dietary uses by man by reason of their vitamin properties in respect to vitamins A, C, E, and K; and the label did not bear, as required by the regulations, statements of the pro- portion of the minimum daily requirements of vitamins A and C and statements of the quantity of vitamins E and K "which would be supplied by the tablets when consumed in a specified quantity during a period of one day, or a quantity reasonably suitable for consumption in such periods; and the label of the tablets failed also to bear a statement that the need for vitamins E and K in human nutrition has not been established. Further Misbranding, Section 403 (a), certain statements in the circulars and placards were false and misleading. These statements represented and suggested that there were widespread deficiencies of vitamin B complex; that the tablets contained significant amounts of all known factors in vitamin B complex; that they contained substantial and nutritionally significant amounts of vitamins A, C, E, and K; and that they would be efficacious in the cure, mitigation, treatment, and prevention of constipation, digestive disturbances, extreme nervousness, insomnia, loss of appetite, skin diseases, inflammation of the eyes, loss of weight, "run down" conditions, muscular weakness, im- paired growth, cataract, nervousness, loss of hair, canker sore mouth, redness and swelling of tongue, sensitiveness to bright light, bow legs, teeth cavities, rickets, poor growth, lack of vigor, restlessness, misshapen bones, retarded growth, loss of "pep," flabby condition of stomach and intestines, heart and blood vessel disturbances, nervous irritability, neuritis, loss of muscle tone, impaired digestion, night blindness, skin eruptions, lowered resistance, dry- ness of eyelids, stomach and intestinal disturbances, nerve degeneration, poor assimilation of other vitamins, gray hair, headache, dizziness, confusion, in- somnia, indigestion, nausea, defective teeth, scurvy, gum diseases, fragile bones, soreness of joints, edema (swelling), and stomach ulcers. There are not widespread deficiencies of vitamin B complex; the tablets did not contain significant amounts of all known factors in the vitamin B complex; they did not contain substantial and nutritionally significant amounts of vitamins A, C, E, and K; and they would not be efficacious in the cure, mitigation, treatment, and prevention of the above-mentioned disease conditions. DISPOSITION: December 10, 1947. A plea of guilty having been entered, the court imposed a fine of $150 on each of the two counts of the information.