Document g2jVkd02oNR3kV4BXqqZvmyqJ

i W. Ke dz ie Te l l e r 512 Ra n g er La n e Sa r a so t a , Fl o r i d a 33577 May 20, 1967 Robert A. Kehoe, M.D. Kettering Laboratories College of Medicine Eden Avenue Cincinnati, Ohio h%219 Dear Dr. Kehoe: I greatly appreciate the opportunity to renew discussion of the lead sul fur hair dye project with you and enjoyed meeting Drs. Kindel and Pfitzer. As promised, I amenclosing a copy of our original submission to FDA. You will note that this includes animal toxicity data on R.D. Hair Dressing which was chosen as representative of products in this field. It contains 2%lead acetate together with some fats, oils and emulsifiers and an adequate amount of sulfur. Although I have related to you in summary my arguments in defence of this submission after it was challenged by FDA, I amalso enclosing a copy of a let ter, (January 9, 1967), which I wrote Dr. Freeman of FDAconfirming ny oral arguments and FDA*s reactions thereto. Please note, too, his reply (March 27, 1967) which in substance agrees to waive animal data in lieu of the type of human data we are nowplanning. You will also recall that you and I agreed that it would be better to reserve any discussion of the elimination cycle to which Dr. Freeman took ex ception in his letter of March 27, 1967. Attached also is a list of the various unfamiliar ingredients which ap peared in some of the hair dye formulations. Opposite each is a definition or chemical equivalent. In addition there is a proposed generic formula carrying the maximum lead content found in the various products sold by members of our group. In cluded also are exact instructions for use which is typical of those accompany ing all trade packages. I amwriting Dr. Freeman that your protocol for this study is nowbeing finalized and that it will be submitted to Dr. Fitzhugh for his review quite soon. This seems in order following iry recent letter to himwherein I in dicated that this would probably be in May. I presume that we can do this in the next fewweeks? Will you do this in person or what will the procedure be? 1*11 look forward to receiving the proposal which Dr. Kindel will be sending to me and call you immediately thereafter. Romsx #600 - Could be Atlas Renex 600 - nonionic ethers from ethylene oxide with nonylphenol "uponal Apaste - sodium lauryl sulfate fromDuPont Lantrol - liquid lanolin oil derived from lanolin, Malmstrom Chemical Corporation Sulfidal - colloidal sulfur, pharmaceutical grade, Heyden Newport Chemical Company Seauestrene A.A. - ethylene diamine tetra-acetic acid 99%+ Geigy Chemical Corporation Arlacel 165 - glyceryl monostearate (acid stable self emulsi fying) Atlas Deity1 Extra - isopropyl myristate, Givauden Delawanna Inc. Potassium 3orbate - Probably a preservative of Pfizer polawax - principally stearyl alcohol with nonionic self emulsifying agent Methyl Chem. - methyl p-hydroxybenzoate U.S.P. XI7 Cudbear No. 1 powder - a natural lichen derived red coloring N14938.01