28998. Hilcoa food supplements. (F.D.C. No. 45527. S. Nos. 85-682/4 R.) QUANTITY: 28 ctns., each containing 10 450-tablet pkgs. of protein with lecithin tablets and 146 ctns., each containing 336 vitamin-mineral tablets and 120 protein with lecithin tablets, at North Kansas City, Mo. SHIPPED; On 2-16-61 and 3-7-61, the 146-etn. lot was shipped in part from Oak- land, Calif., by Hilcoa Co., of San Jose, Calif., and in part from Los Angeles, Calif., by Toland Labs., of Burbank, Calif., and the 28-ctn. lot was shipped from Oakland, Calif., by Hilcoa Co. LABEL IN PART: (Ctn.) "Hilcoa Improved Food Supplement PROTEIN WITH LECITHIN Meatless * * * Soya bean powder defatted, isolated soya bean protein concentrate, edible casein, casein hydrolysate and protein concen- trates, of wheat, corn and cottonseed. Flavored with natural powdered orange juice and sweetened with 1.3% sodium cyclamate * * * Formulated for and Distributed by The Hilcoa Company, 195 East Taylor Street, San Jose, Cali- fornia," and "Hilcoa Improved Food Supplement Natural or Organic Vitamins and Minerals including Protein with Lecithin Bonus Paks * * * Formulated for and Distributed by The Hilcoa Co." ACCOMPANYING LABELING: Leaflets entitled "Hilcoa Highlights Special Edi- tion Principle Takes Precedence," "Hilcoa Highlights Nov-Dec 1960 Season's Greetings," "Hilcoa takes the lead," and "Food Comes First"; circulars en- titled "Is Hilcoa for You?" and "Bank on Hilcoa for Your future"; a distrib- utor's "Handbook" ("Hilcoa" on black cover), and a distributor's "Sales Manual" ("Hilcoa" on red cover), and form letter on a "Hilcoa" letterhead beginning, "It was a pleasure. . . ." LIBELED : 3-27-61, W. Dist. Mo.; amended libel 5-18-61. CHARGE: Both lots of articles, 403(a)—when shipped, the label statement "Protein with Lecithin Food Supplement" suggested and implied that the protein and lecithin in the articles were present in significant amounts for special dietary use; which statement was misleading, since the protein in the articles was present in insignificant amounts for such purpose; and lecithin had no special nutritional significance; 403(a)—when shipped, the label state- ment "Twice, three times, or even more than the recommended daily intake may be desirable to augment your normal diet," was false and misleading, since it suggested and implied that a daily intake of over 108 tablets of the articles was nutritionally desirable and that the normal diet required supple- mentation with protein and lecithin; which suggestion and implication were contrary to fact; and the label statements "The recommended intake of 12 tablets will provide 720 mg. lecithin (soya bean) plus 62% protein * * * plus arginine 28 Eggs. * * * Tyrosine 15.7 mgs." suggested and implied that the articles under the recommended directions for use would supply 62% of the minimum daily requirement for protein, and would supply amino acids in addition to protein; which statements were false and misleading, since they were contrary to fact; and 403(a)—when shipped, the accompanying labeling contained false and misleading representations that the "vitamin and mineral" product was significantly more effective for special dietary use when con- sumed with the "protein with lecithin," and that the combination of both products resulted in a complete program for special dietary use; that the articles, under the directions for use, would supply the minimum daily re- quirement for proteins; that most individuals did not get enough proper whole- some food due to nutritional losses resulting from storage, processing, cooking, and selection practices; that the articles supplied an abundance of high quality protein to correct improper protein intake; that the average consumption of protein was less than 50 percent of the minimum daily requirement; and that the lecithin in the articles would supply for special dietary use a signifi- cant amount of essential unsaturated fatty acids and an abundance of impor- , tant elements found in all living cells. 28-carton lot of protein with lecithin tablets, 403(a)—when shipped, the label statements "an important food in normalizing and maintaining body weight" and "every cell tissue and organ in the human body is essentially pro- tein," were false and misleading, since they were contrary to fact. 146-carton lot of the articles, 403(a)—when shipped, the label bore false and misleading statements and representations, namely, the statements "vitamins and minerals," "L-lysine monohydrochloride * * * need in human nutrition has not been established," "Natural or Organic," and the representations that the ingredients sodium, chlorine, sulfur, potassium, magnesium, zinc, man- ganese, copper, unsaturated fatty acids from safflower and lecithin, wheat germ, biotin, choline, citrus bioflavonoids, hesperidin complex, inositol, l-lysine monohydrochloride, chlorophyll, bladderwrack, dulse, and Irish moss are present in significant amounts or are of special nutritional significance in the article for special dietary use; 403(a), the accompanying labeling contained false and misleading representations that all ingredients of the article were natural or organic and were balanced; that all the micronutrient food factors in the article were lacking in our modern diets; that the unsaturated fatty acids in the article were recognized as vitamin F; that the article with "Pro- tein with Lecithin" represented an amazing, complete combination which makes other double-tablet supplements obsolete; that the article met the re- quirements of applicable Federal laws and regulations and was based on U.S. Government standards; that the article supplied all the essential elements for proper and complete nutrition; and that everyone needed a complete, balanced, natural and organic food supplement. The articles were alleged also to be misbranded under the provisions of the law applicable to drugs as reported in notices of judgment on drugs and devices, No. 7207. DISPOSITION : 4-25-62. Default—destruction.