Document pg7n3KJzG1Q5kj8VGDemyZNj

Cbu unit tee of the Pr ogr essive H air l/e Indust ry Ro o m 510-11, 60 E a s t 42n d St r e e t N e w Yo r k , N e w Yo r k 10017 M ember x Co m be Ch em ic a l . I n c. W hite Plains, N. V. H ess H a ir M il k L a r s. St. Paul, Minn. H o o d s H a i r Pr o d u c t s. I n c : M adrid, la. ' L a ser L a bo r a t o r ies M inneapolis, Minn. M a jest ic D r u c Co . New York, N. Y. Pea r so n Ph a r m a c a l Co . M iami, Fla. Ra y m o n d R e s e a r c h C o r e . New York, N. Y. Sc N R a y C o m p a n y Bronx, New York Pa u l W e st p h a l , I n c New York, N. Y. Kenneth A. Freean, Ph.D. Division of Color Certification and Evaluation . Department of Health, Education and Welfare Food and Drug Administration Washington, D.C. 2020^ January 9 1967 Dear Dr. Freenan: We greatly appreciate the attentive and considerate attitude displayed by you and your associates during oar visit to your office on December 5th. As a natter of record, our own group con sisted of the following I Ivan Combe, Combe Chemical, Inc., White Plains, H.Y. Jule Gordon, Hood's Hair Products, Inc., Mew York, H.Y. David Garlen, Haxel Bishop Inc., Union, H.J. W. Kedsie Teller, Coabe Chemical, Inc., White Plains, H.Y. As you requested we confirm our remarks which da.alt chiefly with points raised in your letter to us of October 20, 1966. Therein you expressed concern that the animal experiments de tailed in our presentation of September 1, 1965 appeared to oast doubt on the safety of lead-containing hair dyes. Apart from the question of comparability of cutaneous absorption, it would see that a possible aisunderstanding resulted in overlooking im portant factors so that the experiment did not follow huaan use. Also it did not allow for the elimination cycle following the ^ abnormal exposure. ' As explained to your group, these facts are important in judging the relation of the experiment to human use: Directions on all lead hair coloring products sold by our group call for daily application only until the desired hair oolor is acquired and thereafter once or twice a week to maintain that shade. Stash a roglsan will require application of about five fluid ounces of product over the first ninety day period and approximately an ounce per month thereafter Since the product is applied to the hair, there is probably not more than one half ounce viiioh reaches the skin during the ninety days of first use. That which is applied to the hair be comes insoluble through reaction with carbon dioxide and sulfur compounds. In the lowest dose animal experiment, 0*5 1./kg. was applied daily to the shaven skin, which area was incidentally Pi e Ivo l//i-n about one fifth of the body area, This is at a rate of one end one-sixth flui i ounces per day, or over tvo hundred times the amount rescuing the skin of a human during the ninety, day experiment. It is an accepted fact that lead acetate m&y penetrate the skin of certain animals, tut it is our position that the ninni experiments do not hear on nuraan use. e are fortunate that c record of the proceedings o.t the Symposium on Environmental Lead Exposure held in December 1965 received the attention of both your group and ourselves. Ve know of no more complete e treatise on the subject of lead toxicity and are grateful that ve can refer to the many pertinent opin ions and facts contained therein. Of prrticulxr importance are the statements of the Deputy attorney -.ene-ral, Dr. uehrig 1, and Dr. Ir-lon U. onith 10, If of Vsyr.e University, bn In of whom ooint out that lead is one toxic material about which we know more than scry other. 'Pertinent to our data on urine lead levels of U p regular loop fere uiK;~s of our products are the meny references > 1110 1 snow the acceptance o ' r m h fipuros as n basis for judging exposure and healthful status of subjects. r,xl,.. "gf L,f , 97,19,30,32 and 33. These proceedinrs also abound with ,,vtier nsubject. 3,1,10,12,13,16,17,10,1;,20 and 2L. a cu o or k ovuta u- ox the ' Adequate information or* toxicity is ;,n t-rr.i - d . 1/', O,!'*;net ft. Vital to nvr consideration are st:. te lentg or- .-,<L- aa-nor; tint dofinding our position. 9,22 and 13. In our sincere efforts to cooperate further in ectlying with, your wishes to learn more about our products, ve told of oi*r conversation;; viih Dr. fobert Kehoo, whom we all recognise as a foremost autnoricy on .reel toxicity, he has reviewed your letter of October 20th to us and arranged with Dr. Radford, present director of Kettering Laboratory, College of .iealcine, University ox Cincinnati, Cincinnati, Ohio, to carry out a human stud/ project on our products. Dr. Kehoe believes that animal studies are unnecessary, lie does not. relieve that lead scetete is absorbed through skin of humans and that if there is any up take, it mU3t come by ingestion. Further, he considers that blood and urine lead levels on a dozen individuals who use such tn heir dye will be sufficient to reveal the facts. In our preliminary planning with him it was believed tost generic formula would suffice to determine a base line of effects of exposure, Subsequent studies on very few subjects on each brand would reveal whether various wetting agents, emulsifiers ;.nd other ingredient.3 vitiated the base results. Ve sniicipete that quantitative compositions of our various products will be weeded by him. here in your Dr. Fitsitugh voiced the opinion that n program which satisfied Dr. Kehoe would seem quite definitive as answering any uncovered attestions on safety of' hair 0013195 Pac Thre 1/ 9/67 y*s, Dr. HLunenthal also said that turnan tost* woold bo eonrincing. Aecardingly, it i* car intontion to ask Br. Xehoa to noot with your gronp te diso tho doslga of a atody vhieh Xottaring L&boratory would uadertako ador his diroetion* la a reeont phono oonrersation with hin, it as loarnod that bo will subnit a onggested procrea to a* in Janaary* It is our plan to eoasdssion hi to neot with auch swMbers of your staff as you desgnate. Tho Chairnan of oar Coawittee, Mr. Jalo Gordo, has askod no to infom yon that tho aonbor listad o our lottorhoad a Rayaond Hosoareh Corp., has beoa aeqnired by Hasol Blshop Company, 3ac,, who will soon dotem i n o if thoy will par ticipato in our sprottp study or carry ont a rosoaroh projoet of thoir ewn. 3h oithar eyent yon will he inforned of thoir deeision. IsSTjs Vory truly your8, V. Kedaie Taller Technical Consultant 0 0 13 1 tJG