WIXLIB

.JANSSEN--WO2-4171U, S. DEPARTMENTOFHEALTH,EDUCATION,ANDWELFAREFood and Drug AdministrationWashington 25, D, C.FOR IMMEDIATERELEASEMonday, November 27, 1961HEW RBOThe Food and Drug AdministrationWashington,productsfalsec.,D.of Nutri-Bioof the Nutri Bioand misleadingNutri-BioProteinBio Naturalwere in violationclaims,it chargedThe otherand Proteinin the Federalof the Federalin, and whileLabelingInstantDistrictFridayand threeotherto be promoted byproductsseizedwereMix, and Nutri-BioBaby held for saleliteratureNutri BioCorporation;Nutri BioSales Manuals;and variousotheraftera "General'sSalesand Recruitingplan,FDA chargedthe variousof the arteries,nervousness,lossrheumatism,of weight,reprints,labelingTabletsfor the preventionthe productsin interstatethe misleadingconunerce.claimsManual" used by top-leveland books,the Vitamin and Mineralthatby Bob Cummings, a vice-presidentused in the salespromotionand effectiveshipmentcharged to containleafletsthatCourt allegedFood, Drug and Cosmetic Act when shipped,the book, "St ay Young and Vital,"thatthatTabletslastor Organic Vitamins-Minerals-Protein.Papers filedwhileVitamin and MineralCorporationlabelingTabletstoday announced seizureKits;Nutri-Biorecordsitems "representrespiratoryinfections,loss of appetite,(More) .of heartanemia,of thedistributors;Program Kits;and filmstripsand the Baby-Bio articleor treatmentincludedand suggestare ity,chronicin

HEW-R80 2 (diarrhea,death,palpitationarthritis,diabetes,of the heart,eczema, virusand athleticto feeland have a zest for living,juvenileiiIdelinquency,and g and fullconditions,:presencerutin,thereinbiotin,which representdietarybio ids,complex, hesperidinalfalfajuicezinc,nutritivefactorsand tracethatallingredientsthe articlesthatthe articlesdietarysupplementationnaturalor organicthey are contraryfor suchthey are of significantuse by reasoncholine;elements;are essentialand balancedpeopleare of special(More)andand (Baby Bio)vitamineveryone needs food supplements,to fact."acid,magnesium, mont in the articlesthatinandthein the world even thoughsignificanceuse becausewhich statementsof theparaminobenzoiccomplex,manganese,are completeor therapeuticorigin;thatarticlesand powder concentrate,copper,thatof theseinositol,chlorine,food supplements,and thatpreventare f lseand effectiveor therapeuticAmerican people are the most under-nourishedover-fed,promote growth,which statementsand suggestfattyTablets)(both lots)human nutrition,strength,to be calm and vibrantthe labelingsupplementationof unsaturated(Vitamin and Mineralpotassium,growth,and purposes."statementsvalue for specialof pep,are not adequateThe Government also charged thatIkidney diseases,living,to stay yowtg and vital,the articlesprematurelack of normal intelligence,and for other purposes,sincesenility,lung cancer,tuberculosis,to promote health,ability,imbalance,infections,high blood pressure,for reducing,mentalfor specialthe ingredientsare falseand misleading,are ofsince

J ,HEW R80- 3 -It was also charged that(!Protein(meatless)Tabletsadequate and effectivepressure,poor digestion,and well being,blood and organs strongand healthy;tomalnutritionproteinis near universal;and requiresreq irementis increased(meatless)organic;for proteinby physicalTablets)thatthat the articleis of fornia,which statementsElk Grove Village,of Washington,Ill.D.c.,pointsare naturaland thatorthe articleand for thera are falseand misleading,for such diseases,contraryto fact."Corporation,Beverlyin Californiaand a warehouse inThey were seized in possessiona distributorthe minimum dailysupplementationor since they are otherwisefrom variousinFood Supplement Proteinall protein;The products were shipped by the Nutri Bioand thatthe need for proteinthe articledietarytissues,and maintainis deficientthatthatare not adequate and effectiveand purposes,ability,and for other purposes;and (Nutri Biopeutic use as a source of protein;conditionsto attainwith protein;is practicallyand to beathleticdietareof abnormal bloodto keep muscles,that the ordinaryvalue for specialsince the articleslong life,has been established;allvigor,Mix andthe articlesand preventionbe alert;supplementationInstantmental deterioration,energy, growth, healthfor zestfulfor Proteinand suggest thatof pep, promote vim, vitality,normal body weight;("representfor the treatmentconstipation,young and fullthe labelingof R. B. Andrews,of Nutri Bio.Ill)

286FOOD, DRUG, AND COSMETIC ACT[D.D.N.J.poisonous insect bite, simple head-ache, neuralgia, wrenches, children's minorinjuries, and toothache.Squaw Paw Herbs, 502(a)-whileheld for sale, the labeling of the articlecontained false and misleading representationsthat it was adequate andeffective as a treatment for biliousness, colds, piles, pain in back, neck,shoulders or hips, heartburn, heart palpitation, biliousness or sick headache,sour or sick stomach, belching, bloating, gas on stomach, rheumatism, lumbago,female complaints, bladder trouble, kidney trouble, asthma, indigestion, colitis,blood disease, various skin diseases, ulcers, liver trouble, and appendicitis.DISPOSITION: 12-13-61. Default-destruction.(6945. Special dietary foods. .(F.D.C. No. 45946. S. Nos. 68-585 R, 68-589 R.)QUANTITY: 11 250-tablet btls. of Alli1,er and 1 300-tablet l: tl. of Pap-Okra,at Tulsa, Okla.SHIPPED: 1-27-61, from Santa Rosa, Calif., by Randal Nutritional Laboratories.LABELIN PART: (Btl.) "Randal's .A.lliver Tablets * * This product containsthe finest of Livers from healthy Reindeer * * * Manufactured by RandalNutritional Products, Santa Rosa, California" and "Randal's Pap-Okra TabletsContains: Papaya (entire)Cabbage (juice)Okra (entire).Alfalfa (juice)Comfrey (entire)PhytolaccaManufactured by Randal Nutritional Laboratories Santa Rosa, Calif."LIBELED: 13-61; amended libel 8-22-61, N. Dist. Okla.shipped(Allivertablets),the label statementsCHARGE: 502 ( a )-when"valuable in all cases when a raw liver is indicated" and "retaining enzymevalues" were false and misleading; and (Pap-Okra tablets), the label contained false and misleading representations that the article was adequate andeffective to promote digestion and elimination.The libel alleged also that certain other products were misbranded underthe provisions of the law applicable to foods, as reported in notices ofjudgment on foods.DISPOSITION: On 8-23---61, the case was transferred to the Southern Districtof California.1-25-62. Default-destruction.6946. Nutri-Bio food supplements. 1(F.D.C. No. 46753. S. No. 3-519 T.)QUANTITY: 99 pkgs. of vitamin and mineral tablets, 100 pkgs. of Protein tablets(meatless),177 pkgs. of Baby-Bio 26 pkgs. of Protein Instant-Miw,atWashington, D.C., in possession of R. B. .Andrews, distributor.SHIPPED: Between 10--2-61 and 11-8-61, from Elk Grove Village, Ill., Los .Angeles and El Segundo, Calif., by Nutri-Bio Corp.LABEL IN PART: (Pkg.) "Nutri-Bio Vitamin and Mineral Tablets * * * fromnatural food sources * * * Each Carry-Pak Contains a 7-day adult supply* * * contains 26 Nutri-Paks * * * 364 Vitamin Tablets * * * 728 MineralTablets better NUTRition thru BIOchemistry";(pkg.) "Nutri-Bio * * * Protein (meatless) Lemon Flavor [or "Chocolate Flavor"] * * * Each CarryPak contains 45 protein tablets * * * in Ready-To-Eat Tasty ConcentratedTablets * * * 1080 Tablets"; (pkg.) "Nutri-Bio * * * baby-bio natural or organic Vitamins-Minerals-Proteins* * * 60 :fivegram Baby-Paks 300 gramsnet wt. * * * Each 'Baby-Pak' contains a one-day supply * * * This packagecontains 60 'Baby-Paks'";and (pkg.) "Nutri-Bio * * * Protein ready-to-useinstant mixVanilla Flavor * * * 1 lb. ,net wt. [or "3 lb. net wt."]."(

6901-6960]NOTICESOF JUDGMENT287ACCOMPANYINGLABELING: Nutri-Bio Sales Manuals; Nutri-Bio Program Kits;films and record sets entitled "You and Your Future with Nutri-Bio"; recordsentitled "Give Yourself a Break," "Special Release, Meet Bob Cummings,""Nutri-Bio Presents: FLASH, The L. Lew Henry Story," and "Special Release,Take Care of You For Me"; books entitled "Stay Y.oung & Vital" by Bob Cummings, "Overfed But Undernourished" 8th Edition, by H. Curtis Wood, Jr.,"Let's Eat Right To Keep Fit" by Adelle Davis, "The National Malnutrition"by D. T. Quigley, "Feel Like a Million" by Catharyn Elwood, and "Mirror,Mirror on the Wall" by Gayelord Hauser; booklets entitled "Modern MiracleMen" an article by Rex Beech and "The Organic Revolution in Nutrition" ;leaflets entitled "Are We Starving at Full Dinner Tables," "Faulty Diet isBlamed for Youth Delinquency," and "Malnutrition affects 999 out of 1000";booklets entitled "Capsuled Vitamins when do we need them"; leafletsentitled "Nutri-Bio News, August 1001," "Nutri-Bio News, October 1961,""Southern Association," "For Balanced Nutrition * * * Basic Foods," "ANutri-Bio Product for Everyone/Do You Know," "The Nutri-Bio Programfor Better Living," "Baby-Bio by Nutri-Bio," and "Many of You Have SeenMy Movies"; reprints of advertisements "Parents Magazine, October 1960,""Parents Magazine, November 1001," and "Life Magazine May 25, 1959'';booklets entitled "Nutri-Bio Protein Recipes" and "Why a food supplement?";pamphlets entitled "For More Radiant Living" and "Nutri-Bio Sources";copies of "Nutri-Bio Questionnaire"; cards "Better Nutrition Through Biochemistry" ; sales and recruiting kit; order forms; starting kit and Geneml'sManual; and reprints of "Newsweek July 1961."LIBELED: 11-24-6!1, Dist. Columbia.CHARGE: 502 ( a )-when shipped and while held for sale, the labeling containedfalse and misleading representations that the articles ( vitamin and mineraltablets and Baby-Bio)were adequate and effective for the treatment andprevention of heart trouble, hardening of the arteries, rheumatism, respiratory infections, impotency, frigidity, nervousness, loss of weight, loss of appetite, anemia, pyorrhea, chronic diarrhea, .palpitation of the heart, mental imbalance, senility, premature death, reduced resistance to disease and infection,paralysis, undulant fever, arthritis, eczema, virus infections, lung cancer, kidney diseases, diabetes, high blood pressure, tuberculosis, and lack of normalintelligence, for reducing, to promote health, beauty, radiant living, growth,strength, and athletic aibility ; to feel young and full of pep ; to be calm andvibrant and have a zest for living; to stay young and vital; promote growth;prevent juvenile delinquency; and .for other purposes; and that the articleswere of significant value for special dietary supplementation or therapeuticuse by reason of the presence therein of unsaturated fatty acids, inositol,para-aminobenzoic acid, rutin, biotin, bioflavonoid complex, hesperidin complex, and choline; -and ( vitamin and mineral tablets) alfalfa juice and powderconcentrate, potassium, sulfur, chlorine, copper, zinc, manganese, magnesium,montmorillonite, other nutritive factors and trace elements; and (Baby-Bio)protein; (both lots) that all ingredients in the ·articles -were essential inhuman nutrition; that the articles were complete and ·balanced vitamin andmineral food supplements; that everyone needs food supplements; that theAmerican people are the most undernourished people in the world even thoughoverfed; and that the articles ,are of special significance for special dietar;rsupplementation or therapeutic use because the ingredients were of natural ororganic origin; and (Protein Instant-Mia: and Protevn (meatless) tablets)