Document MJOXKV5amY68L13jVnbLEZBoM

W. K e d z i e Te l l e r 512 R a n g e r L a n e S a r a s o t a , F l o r i d a 33577 October 31, I960 Robert A. Kehoe, M.D. Kettering Laboratories College of Medicine Eden Avenue Cincinnati, Ohio 4-5219 Dear Dr. Kehoe: In a phone conversation with Miss Peaslee of jour office, I learned that jou will be out of town until next Monday, and in consequence promised to write you about ny problem in hopes that you might give it some consideration. I am a consulting chemist and for a number of years operated the Columbus Laboratories in Chicago dealing with foods, drugs and cosmetics, and in pert toxicological problems connected therewith. Currently I am semi-retired but because of my past experience in the -field have been retained by a group of lead sulfur hair dye manufacturers to advise them in connection with a submis sion to the FDA concerning the safety of these items. After about two years laboratory and clinical work done by extremely competent persons, we submitted to the FDA in September 1965 the following da te: 1. A carefully controlled study of the effects on rabbits which have been tree-ted with mas sive doses of one of the widely sold lead sul fur hair dyes which shows nothing alarming. Herein the rabbits have been exposed to many times the amount of product that humans use in normal hair coloring. 2. A compilation of urine lead data from one hun dred and five persons who have regularly used the commercial products currently under considera tion. 3. A literature survey which shows the opinions of experts regarding the relatively low absorption of lead through the unbroken skin, the levels of blood and urine lead under various conditions, normal and pathological, and other pertinent in formation. At this time I won't burden you with details on the rabbit studies except ing to say, as expected there was lead uptake in soft tissues and bones, this because the excessively high dosages caused changes in the normal skin barrier. The human lead data showed urine; levels to be within the normal limits expres sed by yourself. N14816 Dr. Kehoe Octob er 31, i9 6 0 Ve have just received a reply from Mr. Freeman of the Color Division of FDA advising us that the data submitted shovs that the products under con sideration are unsafe. This despite the fact that the human data is negative and the rabbit uptake is explainabiy high. I am fully aware of the literature on this subject and in particular your veiy valuable contributions thereto and have a copy of the Symposium on Environmental Lead Contamination, December 13-15, 1965. Mr. Freeman refers to this compilation of proceedings as condemning our cause, while my inter pretation is exactly to the contrary. He is asking for an enormous amount of work, the cost of which is completely out of keeping with the dollar vol ume of business done by this industry. It is my sincere belief that if you could give this problem some study, you could advise me on an approach that might change the attitude of the FDA officials and make it favorable to continuance of this industry". Accordingly, I shall hope that when I call you the first of next week it will be possible for you to agree to let me visit you in Cincinnati to discuss details surrounding the above, with the hope that you may find it possible to gui.de us towards a prevailing position. VKT/vt 00KZ 0 ^ u-* O ", p i