30298. 40 Plus and Vita-Bio dietary supplements. (F.D.C. No. 50697. S. Nos. 19-439/40 A.) QUANTITY: 1,582 60-tablet btls. of 40 Plus vitamin tablets, 1,510 60-tablet btls. of 40 Plus enzyme tablets, 1,510 60-tablet btls. of 40 Plus mineral tablets, 1,438 60-tablet btls. of Vita-Bio vitamin tablets, and 1,510 60-tablet btls. of Vita-Bio mineral tablets, at Pittsburgh, Pa. SHIPPED: Between 12-14-61 and 2-9-62, from Newark, N.J., by Lit Drug Co. (Lit Sales Co., Inc.). LABEL IN PART: (Btls.) "Nu-Life Natural Organic 40 Plus Vitamin Tablets 30 Day Supply * * * High Potency Vitamins * * * Each two tablets furnish * * * Liver Stomach Concentrate with Intrinsic Factor Concentrate 100 mg." ; (btl.) "Nu-Life Natural Organic 40 Plus Enzyme [or "Mineral"] Tablets * * * Distributed by Nu-Life Company * * * Pittsburgh 20, Pa."; (btl.) "Nu-Life Natural Organic Vita-Bio Vitamins 30 Day Supply * * * Each two vitamin tablets contain * * * Liver Complex Concentrate with Intrinsic Factor 30 mg."; and (btl.) "Nu-Life * '* * Vita-Bio Minerals 30 Day Supply * * * Distributed by Nu-Life Company." ACCOMPANYING LABELING: Empty combination boxes for the three 40 Plus articles labeled in part "Nu-Life Natural—Organic 40 Plus Vitamin+Min- eral-f Enzyme Food Supplement For Folks Over 40"; and empty combination boxes for Vita-Bio articles labeled in part "Natural—Organic Vita-Bio A 30 Day Supply 60 Vitamin Tablets Nu-Life 120 Mineral Tablets A Vitamin and Mineral Dietary Supplement For Your Most Active Years." LIBELED : 11-9-64, W. Dist. Pa. CHARGE: 402(a) (2)'(C)—while held for sale, the 40 Plus vitamin tablets and the Vita-Bio vitamin tablets contained intrinsic factor, a food additive, which was unsafe within the meaning of 409, since it and its use and intended use were not in conformity with a regulation or exemption; 403(a)—:when shipped and while held for sale, the labeling of the 40 Plus vitamin tablets, 40 Plus mineral tablets, and 40 Plus enzyme tablets was false and misleading in that the listing and references to the inclusion in the articles of the ingredients para-aminobenzoic acid, choline, inositol, biotin, vitamin K, lemon bioflavonoid complex, rutin, glutamic acid, nucleic acid, unstaturated fatty acids, yeast protein enzymatic hydrolysate, soya bean lecithin, liver-stomach concentrate with intrinsic factor concentrate, papain, pepsin, malt, duodenal substance, hesperidin complex, 1-lysine, wheat germ, rose hips, black strap molasses, bone meal, young cereal grass, alfalfa, Pacific and Nova Scotia kelp, water- cress, parsley, carrot tops, proteins, red bone marrow, beef peptone, mylase enzyme, prolase enzyme, cellace enzyme, magnesium, copper, manganese, and potassium, represented and suggested, contrary to fact, that the nutritional value of the article was enhanced by the presence therein of these ingredients; in that the name of the article "40 Plus," the name of the firm "Nu-Life," and . other statements in the labeling represented, suggested and implied, contrary to fact, that persons over 40 years of age had special vitamin-mineral enzyme requirements; that they required dietary supplementation; that the articles would impart new life to a person over 40; and that the articles would add vigor and energy to a person over 40; and in that the statement "Need in human nutrition not established" as applied to pantothenic acid, copper, and manga- nese was false and misleading, since the need in human nutrition for these ingredients had been established; 403(a)—when shipped and'while held for sale, the labeling of the Vita-Bio vitamin tablets and the Vita-Bio mineral tablets, was false and misleading in that the listing and references as to the inclusion in the articles of the ingredients para-aminobenzoic acid, choline, inositol, biotin, whole liver (desiccated and defatted), liver complex con- centrate and intrinsic factor, citrus bioflavonoid complex, soya bean lecithin, sunflower seed oil (containing unsaturated fatty acids), yeast protein enzy- matic hydrolysate, nucleic acid, glutamic acid, rice brand concentrate, red bone marrow, papain, peppermint leaves, rutin, wheat germ powder, vitamin K, malt, magnesium, copper, and manganese, represented and suggested, contrary to fact, that the nutritional value of the article was enhanced by the presence therein of these ingredients; in that the statement "Need in human nutrition not established," as applied to pantothenic acid and manganese, was false and misleading, since the need in human nutrition had been established for these ingredients; and in that the name of the firm "Nu-Life," the name of the article "Vita-Bio," and other statements in the labeling represented, suggested and implied, contrary to fact, that the article would impart life and vitality to a person and that active persons required additional vitamin-mineral supplementation. DISPOSITION : 12-16-64. Default—destruction.