sumption of the article would insure a diet high in vital food elements; that it was a magic food which would balance the family diet and provide a completely healthful diet; that it was a splendid source of the vitamin B complex; that consumption of the article as directed would insure an abundance of the Bgroup vitamins; that, when used as directed, it would contribute in an important respect to the requirements of the body for vitamin A and calcium; that the contents of one of the jars, 11 ounces of the article, was equivalent to 3 pounds of wheat germ; that each ounce of the article contained 2.02 milligrams of copper; that the minimum daily requirement for riboflavin for adults was 1.8 milligrams; and that the minimum daily requirements for niacin and copper have been established. The article was not a splendid source of the vitamin B complex and would not accomplish the results claimed; the contents of one of the jars, 11 ounces of the article, was not equivalent to 3 pounds of wheat germ, inasmuch as two of the vitamin constituents of wheat germ, Vitamin D and riboflavin, were present in the article in essentially the same amount as are present in wheat germ; each ounce of the article contained a smaller amount of copper than was represented; the minimum daily requirement for riboflavin for adults is not 1.8 milligrams but is 2 milligrams; and the minimum daily requirements for niacin and copper have not been established. Both products: Misbranding, Section 403 (j), the articles purported to be and were represented as foods for special dietary uses by man by reason of their content of vitamin B1, vitamin E, vitamin A, and vitamin B2, and their mineral content of iron, copper, calcium, phosphorus, and (Wheatmix only) iodine, but their labels failed to bear, as the regulations require, statements of the proportion of the minimum daily requirements for vitamin B1, vitamin A, and vitamin B2, iron, calcium, phosphorus, and (in the case of the Wheatmix) iodine which would be supplied by the articles when consumed in a specified quantity during a period of 1 day; and they failed to bear a statement that the need for vitamin E in human nutrition has not been established, or a statement of the quantity of copper which was contained in a specified quantity of the articles. The articles were also alleged to be misbranded under the provisions of the law applicable to drugs, as reported in notices of judgment on drugs and devices, No. 1119. DISPOSITION: On January 25, 1944, the defendant having entered a plea of guilty, the court imposed a total fine of $225 and costs, the fine on the counts charging violation of the food sections of the Act amounting to $150. 6794. Misbranding of Helio Minerals. U. S. v. 3 Dozen Bottles and 3 Dozen Bottles of Helio Minerals. Default decree of condemnation and destruction. (F. D. C. No. 10360. Sample No. 33849-F.) LIBEL FILED: August 6, 1943, Western District of New York. ALLEGED SHIPMENT: On or about June 7 and July 30, 1943, from Detroit, Mich., by the Gordon Service, Inc. PRODUCT: Helio Minerals: 3 dozen 500-tablet bottles and 3 dozen 160-tablet bottles at Buffalo, N. Y. Examination disclosed that the article consisted essentially of seaweed, alfalfa, and parsley leaves; and that 6 tablets, the number directed to be taken in 1 day, would provide only about is of the minimum daily adult requirement for calcium, %o of the minimum daily adult requirement for phosphorus, and of the minimum daily adult requirement of iron for adults and children over 6 years of age, and of the minimum daily requirement of iron for children under 6 years of age. The amount of copper provided was essentially inconsequential. VIOLATIONS CHARGED: Misbranding, Section 403 (a), the designation "Helio Minerals," in the labeling of the article, was false and misleading as applied to a product which consisted essentially of seaweed, alfalfa, and parsley leaves; the statements on its label, "(Dietary Supplement) Contain in Organic (natural) form all of the minerals now known to be essential to nutrition, especially rich in iron, copper," were false and misleading since the article, when taken in accordance with the directions on the label, "3 tablets after breakfast and 3 tablets after evening meal * * Children over three can be given same amount," would provide but a small fraction of the requirements of adults or children for calcium, phosphorus, and iron, minerals which are known to be essential to nutrition, and but an inconsequential trace of copper; and the following statements on its label, "Helio Minerals are prepared in the laboratories of an internationally recognized scientist from his own selection of Macrosystis Pyrifera (Giant Kelp) so as to retain their amazing content of minerals," and "Helio Minerals were prepared to supply minerals in large enough amounts to be of real value," were false and misleading since the article was prepared from seaweed (kelp), alfalfa, and parsley leaves, products which do not contain an unusual proportion of mineral constituents, and, when taken as directed, it would supply but a small fraction of the minerals now known to be essential to nutrition. Further misbranding, Section 403 (a), the statements in an accompanying circular entitled "Feel Better Look Better Helio Minerals and Helio Natural B-Complex" were false and misleading since they represented and suggested that the article was effective, either alone or in combination with vitamin B-complex, to fulfill the promises of benefits stated and implied therein, that is, that the article would enrich the blood, soothe the nerves, add energy, and repair the body; that it would make the user feel better and look better; and that it would increase resistance to disease, protect the bones and teeth, strengthen the heart and nerves, insure good digestion, keep tissues flexible and active, prevent poor muscular control, neutralize excess acids, produce internal cleanliness, aid in the treatment of rheumatism, skin, and other diseases, help one to sleep better, stimulate the appetite, regulate constipation, prevent neuritis, premature aging, cracking of lips, loss of hair, atrophy of oil glands, and loss of weight, promote growth, strengthen vision, courage, and morale, restore color to graying hair, and reduce dark coloring in birthmarks and freckles, whereas, the article was not so effective; and, Section 403 (i), the article was fabricated from two or more ingredients and its label failed to bear the common or usual name of each such ingredient. The article was also alleged to be misbranded under the provisions of the law applicable to drugs, as reported in notices of judgment on drugs and devices, No. 1131. DISPOSITION: September 20, 1943. No claimant having appeared, judgment of condemnation was entered and the product was ordered destroyed. 6795. Adulteration and misbranding of Minavit No. 1. U. S. v. 65 Bottles of Minavit No. 1. Default decree of condemnation and destruction. (F. D. C. No. 11582. Sample No. 39764-F.) LIBEL FILED: January 14, 1944, District of Arizona. ALLEGED SHIPMENT: On or about August 2, 1943, by the Soltan Corporation, Los Angeles, Calif. PRODUCT: 65 bottles of Minavit No. 1 at Tucson, Ariz. Examination of a sample showed that the article contained not more than 750 units of vitamin A, not more than 600 units of vitamin D, and not more than 52 gamma of iodine per tablet. LABEL, IN PART: "Minavit No. 1 Each tablet contains approximately: Vitamin A 1500 U. S. P. Units*** Vitamin D 1000 U. S. P. Units *** Iodine 365 gamma. VIOLATIONS CHARGED: Adulteration, Section 402(b) (1), valuable constituents, vitamin A, vitamin D, and iodine, had been in part omitted from the article. Misbranding, Section 403(a), the label statements, "Each tablet contains approximately: Vitamin A 1500 U. S. P. Units*** Vitamin D 1000 U.S.P. Units*** Iodine 365 gamma," were false and misleading since the article did not contain the declared amounts of vitamins and iodine; and, Section 403 (j), the article purported to be and was represented as a food for special dietary uses by man by reason of its vitamin and mineral content, and its label did not bear, as required by the regulations, a statement of the proportion of the minimum daily requirements of vitamin A, vitamin C, vitamin D, thiamine hydrochloride, riboflavin, calcium, iron, and iodine, supplied by the article when consumed in a specified quantity during the period of 1 day; and the statement that the need for vitamin B and vitamin E in human nutrition has not been established. DISPOSITION: February 21, 1944. No claimant having appeared, judgment of condemnation was entered and the product was ordered destroyed. 6796. Misbranding of Macu Brand Papaya Concentrate. U. S. v. 12 Bottles and 4 Bottles of Papaya Concentrate. Default decree of destruction. (F. D. C. No. 10142. Sample No. 43991-F.) LIBEL FILED: On or about June 28, 1943, Western District of Missouri. ALLEGED SHIPMENT: On or about April 19, 1943, by Macu Fruit Products, from Chicago, Ill. PRODUCT: Papaya Concentrate: 12 1-quart bottles and 4 1-gallon bottles at Kansas City, Mo. LABEL, IN PART: "Macu Brand Papaya Concentrate." VIOLATION CHARGED: Misbranding, Section 403(a), the name "Papaya Concentrate" was false as applied to the article, which consisted of a mixture of papaya pulp, crushed seeds, fruit acids, flavoring, and sugar; and certain statements appearing on its label and in the circular entitled "Drink Papaya (Fruta Bomba)" were false and misleading since they represented and suggested that the article, when used as directed, was a rich source of vitamins; that it was a valuable aid to digestion; and that it would be of value in such conditions as gastritis, diphtheria, ulcers, bowel disorders, dyspepsia, croup, cancer, and gastric fermentation, whereas the article, when used as directed, was not a rich source of vitamins, a valuable aid to digestion, or of value in the conditions mentioned. The article was also alleged to be misbranded under the provisions of the law applicable to drugs, as reported in the notices of judgment on drugs and devices, No. 1126. DISPOSITION: July 30, 1943. No claimant having appeared, judgment was entered ordering that the product be destroyed. 6797. Misbranding of Pretorius Nezets and Pretorius Virvets. U. S. v. 36 Bottles of Pretorius Nezets, 18 Bottles of Pretorius Virvets, and 6 Display Charts. Default decree of condemnation and destruction. (F. D. C. No. 12138. Sample Nos. 57838-F, 57839-F.) LIBEL FILED: April 4, 1944, District of Colorado. ALLEGED SHIPMENT: On or about January 26 and February 22, 1944, by Pretorius Approved Products, from Los Angeles, Calif. PRODUCT: 36 bottles, each containing 180 tablets, of Pretorius Nezets, 18 bottles, each containing 250 tablets, of Pretorius Virvets, and 6 display charts entitled "The Pretorius 'Improve Your Health System' Food Chart for Balancing Meals," at Denver, Colo. LABEL, IN PART: "Pretorius Nezets A Natural Source of Food Minerals," or "Pretorius Virvets A Natural Source of Food Vitamins." VIOLATION CHARGED: Misbranding, Section 403 (a), because of false and misleading statements on the charts, which represented and suggested that it was necessary to supplement the ordinary food intake with Nezets and Virvets in order to insure adequate vitamin and mineral intake, and that if this was done improved health would follow. DISPOSITION: May 26, 1944. No claimant having appeared, judgment of condemnation was entered and the products were ordered destroyed. 6798. Misbranding of Vitalert. U. S. v. 334 Boxes of Vitalert. Default decree of condemnation. Product ordered delivered to a government hospital. (F. D. C. No. 11194. Sample No. 57114-F.) LIBEL FILED: November 30, 1943, Eastern District of New York. ALLEGED SHIPMENT: On or about August 31, 1943, by J. E. Trautman & Associates, Inc., Columbus, Ohio. PRODUCT: 334 boxes of Vitalert at Brooklyn, N. Y. Each box contained 6 small, round pills, fixed in place between 2 strips of cellophane. The box could have held approximately 50 unwrapped pills, and could easily have held at least 18 pills in folded cellophane strips. The statement "6 Vitalerts" was inconspicuously placed on the ends of the box. LABEL, IN PART: "Super Seal Vitamins High Potency Brand Vitalert * Vitamin A 5000 U.S. P. Units Vitamin B, (Thiamin HCL) 3 Mgm. Vitamin B, (Riboflavin) 2 Mgm. Vitamin B. (Pyridoxine) .25 Mgm. Vitamin C (Ascorbic Acid) 30 Mgm. Vitamin D (Viosterol) 500 U. S. P. Units Calcium Pantothenate 1 Mgm. Niacin Amide 20 Mgm." VIOLATIONS CHARGED: Misbranding, Section 403 (d), the container was so filled as to be misleading since its size would indicate that many more pills were contained therein than there actually were; Section 403 (a) because of false and misleading statements on the label, which represented and suggested that use of the article would insure vim, vigor, vital alertness, and health; and that it would balance the dietary intake of the individual when used as a supplement; Section 403 (f), the statement of the quantity of the contents of the article and the statement of the proportion of the minimum daily requirements of the vitamins present in the article were not prominently placed on the label with such conspicuousness (as compared with other words, statements, designs, or devices) and in such terms as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use; and, Section 403 (j), the article purported to be and was represented as a food for special dietary uses by reason of its vitamin content, and its label failed to bear, as required by the regulations, a statement that the need for calcium pantothenate and pyridoxine in human nutrition has not been established. DISPOSITION: February 25, 1944. No claimant having appeared, judgment of condemnation was entered and the product was ordered delivered to a government hospital. 6799. Misbranding of Vitapan Tablets. U. S. v. 1,000 Bottles of Vitapan Tablets. Default decree of condemnation and destruction. (F. D. C. No. 11616. Sample No. 58460-F.) LIBEL FILED: January 11, 1944, District of Columbia. ALLEGED SHIPMENT: On or about October 21, 1943, by the Purity Drug Co., Inc., from Passaic, N. J. PRODUCT: 1,000 bottles, each containing 100 Vitapan Tablets, at Washington, D. C. The article was represented on the label as containing, per tablet, 10 milligrams of calcium pantothenate and 333 U. S. P. units of vitamin B1, in a base of brewers' yeast. LABEL, IN PART: "Improved 'Vitapan' Calcium Pantothenate with Vitamin B1." VIOLATION CHARGED: Misbranding, Section 403 (a), the statements on the label which represented and suggested that the article was effective to prevent the graying of hair and to restore to gray hair its original color were false and misleading since it was not effective for such purposes. DISPOSITION: February 9, 1944. No claimant having appeared, judgment of condemnation was entered and the product was ordered destroyed. 6800. Misbranding of Vigor-Ettes (whole wheat wafers). U. S. v. 102 Cases of Whole Wheat Wafers. Decree of condemnation. Product ordered re leased under bond. (F. D. C. No. 11759. Sample No. 51850-F.) LIBEL FILED: February 10, 1944, District of New Hampshire. ALLEGED SHIPMENT: On or about October 11, 1943. by the Aperion Products Co., from Boston, Mass. PRODUCT: 102 cases, each containing 2 dozen 12-ounce cartons, of whole wheat wafers at Manchester, N. H. LABEL, IN PART: "Vigor-Ettes." VIOLATIONS CHARGED: Misbranding, Section 403 (a), because of false and misleading statements on the label, which represented and suggested that the article was of special nutritional significance by reason of the presence of sodium, magnesium, manganese, sulfur, chlorine, silica (SiO2), and potassium; that it was non-fattening; that use of the article would provide vim and vigor; and that there is a generally recognized quantity of sodium, magnesium, sulfur, manganese, and chlorine needed daily in order to maintain normal nutrition; Section 403 (j), the article was represented as a food for special dietary uses by man by reason of its vitamin A, B, C, D, and E content, and its label failed to bear, as required by the regulations, a statement of the proportion of the minimum daily requirements of vitamins A, B, C, and D, and the quantity of vitamin E, supplied by a specified quantity of the article when consumed during a period of 1 day; and it failed to bear a statement that the need in human nutrition for vitamin E has not been established. DISPOSITION: April 5, 1944. The Aperion Products Co., claimant, having admitted the allegations of the libel, judgment of condemnation was entered and the product was ordered released under bond to be brought into compliance with the law, under the supervision of an employee designated by the Federal Security Administrator. |