Document dQZa5Ge5e8YKdLBr9p3BReLZ9

buniiittee of the Progressive Hair Dye Industry Ro o m 510-11, 60 Ea s t 42n d St r e e t Ne w Yo r k , New Yo r k 10017 Members Co mb e Ch e mic a l . Iw. White Plains, N. V. He s s Ha ir Mil k L\a . St. Paul, Minn. Ho o d s Ha ir Pr o d u c t s . In c . Madrid, la. La s e r La b o r a t o r ie s Minneapolis, Minn. Ma j e s t ic Dr u c Co . New York, N. Y. Pe a r s o n Ph a r ma c a l Co . Miami, FW. Ra y mo n d Re s e a r c h Co r e . New' York, N. Y. St n Ra y Co mp a n y 3ronx, New York Pa u l We s t p h a l , In c New York, N. Y. January 9 1967 Kenneth A. Freeman, Ph.D. Division of Color Certification and Evaluation Department of Health, Education and Wall'are Food and Drug Administration Washington, D.C. 20204 Dear Dr. Freeman: 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 matter of record, our own group con sisted of the following* Ivan Combe, Combe Chemical, Inc., White Plains, 11.1. Jule Gordon, Hood's Hair Products, lac., Bew York, H.Y. David Garlen, Hazel Bishop Inc., Union, H.J. W. Kedsie Telifer. Combe Chemical, Inc., White Plains, BUY. As you requested we confirm our remarks which dealt 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 ef September 1, 1965 appeared to oast doubt on the safety of lead-containing hair dyes. Apart from the question of comparability ef cutaneous absorption, it would seem that a possible misunderstanding resulted in overlooking im portant factors so that the experiment did not follow human 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 color is acquired and thereafter once or twice a week to maintain that shade. Bach a regimen 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 wiiioh reaches the skin during the ninety days of first use. That which is applied to the hair be comes insoluble through reaction with carbon dicocide and sulfur compounds. In the lowest dose animal experiment, 0*5 ml./kg. was applied daily to the shaven skin, which area was Incidentally ?t e Ivo l/i/i-r ucout one fifth of the body urea. This is * a rate of one end one-sixth fluid ounces per day, or over tvo hundred fi :.es the amount rescuing the skin of a human during the ninety, day experiment. It is an accepted fact that lead acetate may penetrate the skin of certain animals, tut it is our position that the animal experiments do not hear on nuaan use. e are fortunate that a record of the proceedings o.t the Symposium on Environmental Lead Exposure held in December 1965 received the attention of both your grouo and ourselves. Ve know of no more complete treatise on the subject of lead tori city 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 -erieral, Dr. uehrig 1, and Dr. hnlph U. Smith 10, If of Vsyr.e University, bn In of whom ooini out that lead is one toxic material about which we know more than arty other. '.Pertinent to our data on urine lead levels of lop regular lorp tcrt rot.":' of our products are the many references which snow the acceptance o" urea fi prts as n basis for judging exposure and heslthfui status of subjects. r ,xl,.L,f > 97,19,30,32 and 33. These proceed in rs also abound with o-'her re .ir-:a cn o :r kr ovutrpe ot the subject. 3,/,10,12,13,16,17,10,1:,20 and 2L. Adequate information or. toxicity is pr z-rr.i -d. i/% O,!'* ; tui Vital to our cor, side rtf ion are st.:. fe xerts or- . ,< L - a a- son; t.ior r-funding our position. 9,22 and 13. In our sincere efforts to cooperate further in c: uxlylng with. your wishes to ieorn more about our products, ve told of our conversations vlih Dr. fobert Kehoo, whom we all recognise as a foremost t.utnority on need toxicity, he has reviewed your letter of October 20th to us and arranged with Dr. Radford, present director of Kettering Laboratory, College of /lealcine, University ox Cincinnati, Cincinnati, Ohio, to carry out a human stud/ project on out* products. Dr. Kehoe believes that animal studies are unnecessary, tie does not. believe 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 i.h?:.t blood and urine lead levels on a dozen individuals who use such an heir dye will be sufficient to reveal the facts. In our preliminary planning with hia it was believed tbst r- generic formula would suffice to determine e, 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 needed 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 questions on sefety of hair 0013195 Pa m Three 1/9/67 dyes* Dr. HLumenthal also said that hsraan tests woold be convincing. Accordingly, it is our intention to ask Dr. Kehoa to seet with your group to discuss the design of a study which Kettering Laboratory would undertake under his direction. In a recent phone conversation with him, it was learned that he will subnit a suggested program to u* in January. It is our plan to consdssion him to meet with such ambers of your staff as you designate. The Chairman of our Cowaittee, Mr. Jule Gordon, has asked ne to inform you that the amber listed on our letterhead an Raymond Research Corp., has been acquired by Basel Bishop Company, lac. who will soon determine if they will par ticipate in our group study or carry out a research project of their own. In either event, you will be informed of their decision. Very truly yours. MKT*js V. Kedtie Teller Technical Consultant