2915. Misbranding of Super Potency Ferro-Plus Liver, Iron, and Vitamin B Complex Capsules, Lackzoom's Garlic & Parsley Capsules in Cold Pressed Wheat Germ Oil, Lackzoom Pure Soybean Lecithin Capsules, Wheat Germ Oil Capsules, Amo-Tabs Amino Acid Tablets (Special Tablets), Lackzoom's "Supreme-A" Food Supplement Capsules, Lackzoom's Super C Tablets, Lackzoom's New Blue Label Hi-B Complex Tablets and Special Capsules. U. S. v. 142 Bottles, etc (F. D. C. No. 27004. Sample Nos. 46655-K to 46662-K, Incl.) LIBEL FILED : April 19,1949, Western District of Pennsylvania. ALLEGED SHIPMENT : The Savoy Drug & Chemical Co. shipped on or about August 24, 1948, from Chicago, 111., a number of tablets in bulk which were labeled "Special Tablets * * * Yeast Amino Acids," a portion of which were re- packed after receipt in Pittsburgh, Pa., into bottles labeled "Amo-Tabs Amino Acid Tablets." The Strong, Cobb & Co., Inc., shipped on or about September 3, 1948, from Cleveland, Ohio, a number of tablets in bulk which were labeled "Special Cap- sules," a portion of which were repacked into bottles labeled "Tablets Lack- zoom's New Blue Label Hi-B Complex." The other above-named products were shipped by various firms between the approximate dates of November 10, 1948, and March 7, 1949, from New York, N. Y., Detroit, Mich., Cleveland, Ohio, and St. Louis, Mo. PEODTJCT : 171 bottles of Super Potency Ferro-Plus Liver, Iron, and Vitamin B Complex Capsules; 164 bottles of Lackzoom's Garlic and Parsley Capsules in Cold Pressed Wheat Germ Oil; 37 packages of Lackzoom Pure Soybean Lecithin Capsules; 300 bottles of Wheat Germ Oil Capsules; 40,800 tablets, from which 15,800 tablets had been repackaged into 265 bottles labeled "Amo-Tabs Amino Acid Tablets," and from which 25,000 tablets were remaining in a drum labeled "Special Tablets * * * Yeast Amino Acids"; 295 bottles of Lackzoom's "Supreme-A" Food Supplement Capsules; 260 bottles of Lackzoom's Super C Tablets; and 18,100 tablets, from which 4,100 tablets had been repackaged into 41 bottles labeled "Tablets Lackzoom's New Blue Label Hi-B Complex," and from which 14,000 tablets were remaining in a drum labeled "Special Capsules." The products were in the possession of the Lackzoom Health Stores, also known as Lackzoom Stores, at Pittsburgh, Pa. The bottles and packages were in various sizes ranging from 35 to 400 capsules or tablets. There were a number of copies of a folder entitled "Keep Healthy" and a booklet entitled "Lackzoom Hi-Lites" on display at a number of the Lackzoom Health Stores. LABEL, IN PAET : "Super Potency Ferro-Plus Liver, Iron and Vitamin B Complex Capsules Each Capsule contains the equivalent of Liver Substance 1:7 7 Grains, Iron (Ferrous) Sulfate 5.2 Grains, Vitamin Bi 1665 U. S. P. Units (Thiamin Chloride-5 Mg.), Vitamin B^ (Riboflavin) 4000 Meg. (1.0 Mg.), Vitamin B? (Pyridoxine Hydrochloride) 50 Meg. (0.05 Mg.), Calcium Panto- thenate 2000 Meg. (2.0 Mg.), Niacinamide 30 Mg."; "Capsules Lackzoom's Garlic & Parsley in Cold Pressed Wheat Germ Oil Each capsule contains approx. 2500 Mg. of clean fresh parsley and peeled garlic (moisture removed) suspended in approx. 155 Mg. of cold pressed wheat germ oil"; "Lackzoom Pure Soybean Lecithin * * * Each Capsule Contains 4 Grains Lecithin"; "Wheat Germ Oil Capsules"; "Amo-Tabs Amino Acid Tablets Three Tablets Contain: Arginine (1-hydrochloride) 1.0 Mg., Cystine (1-hydrochloride) 0.1 Mg., Histidine (1-hydrochloride) 0.1 Mg., Leucine (L-) 1.0 Mg., Isoleucine (dl) 1.0 Mg., Lysine (1-hydrochloride) 0.5 Mg., Methionine (dl) 1.0 Mg., Phenylalanine (dl) 0.1 Mg., Threonine (dl) 0.1 Mg., Tryptophane (dl) 0.1 Mg., Valine (dl) 0.1 Mg. in a base of high-protein brewer's yeast and excipients necessary to prepare"; "Special Tablets * * * Yeast Amino Acids"; "Cap- sules Lackzoom's 'Supreme-A' Food Supplement' Each Capsule Contains not less than 25,000 USP Units Vitamin A"; "Tablets Lackzoom's Super C Each tablet contains not less than 2000 U. S. P. Units Vitamin C (100 Mg. Ascorbic Acid)"; "Tablets Lackzoom's New Blue Label Hi-B Complex Each tablet con- tains : Vitamin Bi 500 USP Units, Vitamin B2 (G) 1000 Micrograms, Vitamin B? 125 Micrograms, Calcium Pantothenate 250 Micrograms, Niacin 10000 Micrograms and such other factors of the Vitamin B Complex as are found in the concentrates of liver and yeast contained in these tablets"; and "Special Capsules Vitamin Bi (thiamin chloride) 1.5 Mg., Vitamin B? (pyridoxine hydrochloride) .125 Mg., Niacin 10.00 Mg., Calcium Pantothenate .25 Mg., Liver & Yeast Base." NATXJBB OP CHARGE: Misbranding, Section 502 (a), the following statements in the folder and booklet with respect to the articles, other than the 25,000- and the 14,000-tablet lots remaining in the drums, were false and misleading since the articles were not effective for the purposes stated and implied: "Can't Sleep Nights? Lackzoom Ferro-Plus. Many people can't sleep nights, are always tired, weak or pale because they are not getting enough iron to build rich red blood. They may be suffering victims of nerves because they are deficient in Thiamin * * * Nervousness, Sleeplessness, Anemia and Indi- gestion, authorities say, often spring from a deficiency of either iron, Thiamin or other B-Complex Vitamins. Here is an easy way to insure a sufficient supply of these factors." Lackzoom's Garlic & Parsley Capsules in Cold Pressed Wheat Germ Oil.- "High Blood Pressure Ills Lackzoom Garlic and Parsley Proves Great Bene- fit. For centuries the vital role of garlic in the treatment of High Blood Pres- sure has been recognized by many people. Garlic is- also recommended as affording marked relief in many cases of varicose veins, infections and intesti- nal poisoning. Parsley is especially rich in the organic iron which is necessary for making red blood, and also as a source of Vitamin A." Lackzoom Pure Soybean Lecithin Capsules.-"Drowsiness Nervousness Lack of Pep May Be Due to Lack of Lecithin! Lackzoom Lecithin. Leci- thin is * * * important to the health of the brain and nerves. It is also believed to increase the production of red corpuscles and is therefore largely used in the treatment of anemia." Wheat Germ Oil Capsules.-"More Pep and Energy Lackzoom Wheat Germ Oil Elixir of Life * * * the 'anti-sterility' vitamin * * * has an effect on the assimilation of lime and magnesium for bones and teeth and also apparently on the reproductive functions of both male and female. Helps to promote vigor and growth, stimulates various glandular functions, sharpens intelligence and promotes mental alertness. A recent national magazine article reports relief in test cases of heart ailment sufferers." Amo-Tabs Amino Acid Tablets.-"When one or more of these 10 'essential' Amino Acids are left out of our diet we suffer certain 'deficiency' symptoms; lowered vitality, poor blood circulation, lack of pep and energy and poor resistance against infection, colds and other respiratory diseases. If the diet is permitted to be lacking in Amino Acids for a prolonged time, serious mental and nervous disorders can result. Certain amino acids are known to have an effect on the function of both male and female sex organs in the body. Serious lack is believed in some cases to be responsible for cataract, failure of hair growth and premature old age. Deficiency in children can interfere with proper growth and bone formation, teeth development or to be the cause of rickets. The only way to be absolutely sure the body is not being deprived of any of these ten essential amino acids is to take them daily in concentrated tablet form." Lackzoom's "Supreme-A" Food Supplement Capsules.-"Colds, Sinus Troubles, Poor Eyesight, Bad Complexion If You Have These Symptoms You Need More Vitamin A-says Walter Eddy, famous vitamin authority * * * A is the vitamin most directly important to good eyesight * * * Also it height- ens resistance to colds and sinus infections and favors growth in young chil- dren * * * Lackzoom Supreme-A Concentrate Vitamin A is described above. When a marked deficiency is known to exist and quick improvement is hoped for, much more than the normal intake of Vitamin A can be used with good results. Lackzoom Supreme-A Concentrate is valuable in such cases." Lackzoom's Super C Tablets.-"Infections Slow Healing Varicose Veins Arthritis May Be Caused by Vitamin C Deficiency Lackzoom Vitamin C * * * slow healing of minor wounds, and too easy infection may be symptoms of deficiency." Lackzoom's New Blue Label Hi-B Complete Tablets.-"Nervousness Irrita- bility. Loss of Pep Kun Down Lackzoom Hi-B Complex Formerly * * * distinguished as the nerve and brain-food vitamin * * * Nervousness, loss of energy, constipation, indigestion, and neuritis are among the symptoms that may indicate Vitamin-B deficiency." The above articles were misbranded while held for sale after shipment in interstate commerce. Further misbranding, Section 502 (f) (1), the labeling of the 14,000-tablet lot of the Special Capsules failed to bear adequate directions for use for the purposes for which the tablets were intended since the labeling failed to bear adequate directions for use for the conditions and diseases for which the tablets were offered in the booklet entitled "Lackzoom Hi-Lites," namely, nervousness, irritability, loss of pep, run-down condition, loss of energy, constipation, indigestion, and neuritis. The 14,000-tablet lot of the Special Capsules was misbranded when introduced into and while in interstate commerce. The 25,000-tablet lot in the drum labeled "Special Tablets * * * Yeast Amino Acids" was alleged to be misbranded under the provisions of the law applicable to foods, as reported in notices of judgment on foods. DISPOSITION : April 26, 1949. David B. Shakarian, claimant, having admitted that the allegations of the libel were true, judgment was entered ordering that the products be released under bond for relabeling under the supervision of the Federal Security Agency. DRUGS ACTIONABLE BECAUSE OF THE PRESENCE OF A HABIT- FORMING NARCOTIC WITHOUT WARNING STATEMENT*