Document NNB0k7mGdzakGMaBGDVv7Bk1w

W. Ke d z ie Te l l e r 512 Ra n g e r La n e Sa r a s o t a , Fl o r id a 33577 January 9, 1967 Robert A. Kehoe, M.D. 947 Green Street, Apartment #3 San Francisco, California 94133 Dear Dr. Kehoe: After much delay which resulted from the necessity for consolidating the thoughts of several, I have finally mailed a letter to the FDA as per the at tached copy. Your very welcome and detailed letter of January 3 was received the day before and I feel that in it you have beautifully covered a procedure that will carry our mission forward. In order to further preserve the confidentiality of the several private formulae sold by members of our industry, I am proposing that each brand own er mail information on his products (in some instances a manufacturer sells two) directly to you. From the meager data at hand, I have determined that the lead acetate content of these several brand compositions runs from 0.60$ to 2.0$. From my experience in compounding lead sulfur hair dyes, I have learned that simple unemulsified lotion type products require as little as 0.6$ lead acetate while a cream or pourable emulsion must contain up to 2.0$ to give satisfaction. Since the simple lotion type is a solution of lead aceta.te in -water with small amounts of glycerin and alcohol and suspended sulfur, it was ins'- thought that the basic information on safety could be acquired through testing such a product. I say this because the creams and emulsified lotions contain such a variety of fats, oils and wetting agents, that the compounding of a generic would in itself be a major project. Furthermore, if it can be demonstrated that the simple lotion type is safe, then the more limited study on each manufacturers' formula from its trade package should bring out any variables. You ask about the urgency of this problem, and I must say that we should aim to have your plan in our hands reasonably soon so that a meeting date can be set up for you with Dr. Fitzhugh some time in February, if possible. In this regard, if you can estimate about when such a meeting would suit your convenience. I'll write Dr. Freeman so that he can restrain his group from any precipitate action. Strange to say, after waiting a year to acknowledge our original submission, they now insist that we hurry. If you should find that a phone conversation with me will in any way facilitate matters, please call me collect. I'm usually sure to be at this number after 7 PM. (313-388-3219) Sincerely- you m( N14814