7345. Adulteration and misbranding of Ocean-Lax and Sea-Soi, and misbranding of other special dietary products. U. S. v. 91 Bottles of West's Imported Sea Vegetable Tablets, etc. Consent decree of condemnation. Products ordered released under bond for relabeling. (F. D. C. Nos. 9608, 9900. Sample Nos. 13926-F to 13935-F, incl., 14804-F, 14811-F to 14816-F, incl., 14820-F to 14827-F, incl.) LIBELS FILED: March 29 and May 12, 1943, Southern District of California. ALLEGED SHIPMENT : From on or about February 17, 1942, to January 23, 1943, by Mineralized Foods, Inc., Baltimore, Md. PRODUCT: 130 bottles of West's, Imported Sea Vegetables Tablets, 223 bottles of Sea Vegecene (Powder), 226 bottles of Ocean-Lax Tablets, 140 bottles of Sodeom Tablets, 63 bottles of Sea-V-Aid Tablets, 118 bottles of Sea-Vo-Kra, 116 bottles of Imported Sea Vegetables Vitaminized with added Vitamin "A," 99 bottles of F Y A Tablets, 201 bottles of D-X Tablets, 16 bottles of Sea-Soi, and 78 bottles of Kalseom. The bottles containing these products were of various sizes, and were located at Los Angeles, Calif. These products consisted essentially of sea weed to which had been added various substances. For details of composition see drugs and devices notices of judgment, No. 1246. VIOLATIONS CHARGED: West's Imported Sea Vegetables Tablets, misbranding, Section 403 (a), because of false and misleading statements on the bottle label and in a circular entitled, " 'West's' Imported Sea Vegetables," which represented, suggested, and implied that there exists in the ordinary foods consumed a substantial deficiency in the mineral elements supplied by the article, which deficiency would result in the various disease conditions named and suggested in the labeling; that use of the article would prevent or correct such disease conditions; and that it was of nutritional and therapeutic value because of the presence of sodium, potassium, and magnesium. Sea Vegecene (Powder), misbranding, Section 403 (a), because of false and misleading statements in the labeling which represented and suggested that the article was of nutritional significance because of the presence of iron, sodium, and phosphorus, as well as other unnamed minerals. Ocean-Lax, adulteration, Section 402 (a) (1), the article contained dele- terious substances, i. e., laxative drugs, including rhubarb, which may have rendered it injurious to health. Misbranding, Section 403 (a), the statements on the jar label and in a circular entitled, "Are You Occasionally Consti- pated?", which represented, suggested, and implied that the article was ap- propriate for food purposes; that the laxative ingredients in the article were derived from the ocean; that the alkalinity and amount of minerals supplied by the article were consequential; and that the use of the article as directed would be effective in producing the results claimed in the labeling, were false and misleading since the article, because of its content of cathartic drugs, was not appropriate for food purposes; the laxative drugs it contained were not derived from the ocean; the alkalinity and the amount of minerals supplied by the article were inconsequential; and the label failed to reveal the material fact that the sea plants and peppermint leaves in the article did not contribute to its laxative effects, and that its use as directed would not be effective in producing the results claimed or suggested. Sodeom, misbranding, Section 403 (a), because of false and misleading .. statements on the jar label and in a circular entitled, "Introducing Sodeom' from the Ocean," which represented, suggested, and implied that the article was of nutritional significance because of the presence of sodium; and that it was of value in treating and preventing the conditions and diseases mentioned in the circular. Sea-V-Aid, misbranding, Section 403 (a), because of false and misleading statements on the bottle label and in a circular entitled, "Are You A Victim of Nerves?", which represented, suggested, and implied that the article was of nutritional value because of the presence of minerals; that it would prevent or correct the diseases and conditions mentioned and suggested; and that the principal ingredients were derived from the sea; and, Section 403 (f); the informati'on with respect to the proportion of the minimum daily requirement of vitamin Bi appeared inconspicuously upon the back panel. Sea-Vo-Kra, misbranding, Section 403 (a), the statements on the jar label and in a circular entitled, "Even Though You Have Ulcers of the Stomach or Intestines," which represented, suggested, and implied that the article was of value in the prevention or treatment of ulcers, and that it was of nutritional value as a source of food minerals and vitamins A, B, C, and D, were false and misleading since the article was not of value in the prevention or treatment, of ulcers; it was not of value as a source of food minerals, with the exception of the extent to which it may have provided a supplementary source of iodine; and it was not a consequential source of vitamins A, B, C, and D. Imported Sea Vegetables Vitaminized with added Vitamin "A," misbranding,. Section 403 (a), the statements on the jar label and in the circular entitled, "Watch Out! Beware of Night Blindness!," which represented, suggested, and implied that there exists in the ordinary foods consumed a substantial deficency in the mineral and vitamin elements supplied by the article, which deficiency would result in the various disease conditions named and suggested, and that use of the article would prevent or correct such disease conditions, were false and misleading since the nutritional elements supplied by the article are easily, available from ordinary foods, and use of the article Would not prevent or correct the various disease conditions named and suggested; and, Section 403 (f), the information with respect to the proportion of the minimum daily requirement of vitamin A appeared inconspicuously upon the back panel F Y A Tablets, misbranding, Section 403 (a), the statements on the jar label and in a circular entitled, "Invitation to the waltz* F Y A For Men and Women past 40," which represented, suggested, and implied that there exists in the ordinary foods consumed a substantial deficiency in the mineral elements supplied by the article, which deficiency would result in the various conditions named and suggested, and that use of the article would prevent or correct such disease conditions, were false and misleading since the nutritional elements supplied by the article are easily available from ordinary foods, and use of the article would not prevent or correct the various disease conditions named and suggested; and, Section 403 (f), the information with respect to the pro- portion of the minimum daily requirements of vitamin Bi appeared incon- spicuously upon the back panel. D-X Tablets, misbranding, Section 403 (a), the statements on the bottle label and in a circular entitled, "Diabetes?," which represented, suggested and implied that inadequacies in the mineral content of foods ordinarily consumed are responsible for the development of diabetes, and that use of the product would prevent or cure this disease, were false and misleading since diabetes is not a deficiency disease resulting from inadequacies in mineral intake, and consumption of the article would not effect the results stated or implied in the labeling. Sea-Soi, adulteration, Section 402 (b) (1), a valuable constituent, iron, had been in whole or in part omitted or abstracted from the article. Misbranding, Section 403 (a), because of false and misleading statements on the bottle label and in a circular, "Nervous . . . Anemic? Sea-Soi?," which represented, scented, suggested, and implied that use of the article in accordance with the directions would prevent or correct the diseases and conditions named and suggested, and that the principal ingredients of the article were derived from the sea; and, Section 403 (f), the information with respect to the proportion of the minimum daily requirements of vitamins A, B, «C, and D, and of iron and phosphorus, appeared inconspicuously upon the back panel. Kalseom, misbranding, Section 403 (a), the statements on the bottle label and in a circular entitled, "Can This Be True?", which represented, suggested, and implied that theie exists in the ordinary foods consumed a substantial deficiency in the mineral elements supplied by the article, which deficiency would result in the various disease conditions named and suggested, were false and misleading since the nutritional elements supplied by the article are easily available from ordinary foods, and use of the product would not prevent or correct the various diseases or conditions named and suggested; and, Sec- tion 403 (f), the information with respect to the proportion of the minimum daily requirements of calcium, phosphorus, and vitamins C and D appeared inconspicuously upon the back panel. x Section 403 (.1), further Misbranding of the West's Imported Sea Vegetable Tablets, Sea Vegecene (Powder), Sodeom, Sea-V-Aid, Sea-Vo-Kra, Sea Vege- tables Vitaminized, F Y A Tablets, D-X Tablets, Sea-Soi, and Kalseom, in that they purported to be and were represented as foods for special dietary uses by reason of their mineral content and, in some instances, their vitamin con- tent also, and the labels failed to bear, as the regulations require, statements of the proportion of the minimum 'daily requirements of the minerals and vitamins which would be furnished by specified quantities of the articles when consumed as directed during a period of 1 day, and, in the cases of the Sea-Vo- Kra, Sea Vegetables Vitaminized, F Y A Tablets, and D-X Tablets, the names of the particular food minerals other than iodine upon which use of the food was based. Misbranding of all of the articles and Adulteration of the Sea-Soi were also alleged under the provisions of the law applicable to drugs, as reported in the notices of judgment on drugs and devices, No. 1246. DISPOSITION : On August 10,1943, Mineralized Foods, Inc., claimant, was granted its motion for the removal of the libel proceedings to a district of rea- sonable proximity to the city of Baltimore, Md. On October 7, 1943, the cases having been transferred to the District of Columbia and an order entered for the consolidation of the cases, and the claimant having consented to the entry of - a decree, judgment of condemnation was entered and the products were ordered released under bond for relabeling under the supervision of the Food and Drug Administration.