Document Y0ybo4ObNQwKGXvz1Rd0wZNn

MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD .AND DRUG ADMINISTRATION TO Robert M. Schaffner, Ph.D., Director Office of Technology, HFF-400 DATE: December 12, 1973 FROM Acting Director, HFF-440 Division of Cosmetics Technology SUBJECT: Letter by Dr. W. Nashed of Johnson & Johnson to Dr. Robert Schaffner, Ph.D., dated 11-20-73 Enclosed is the background information you requested in regard to Dr. Nashed's letter of November 20, in which he requested a meeting of Johnson & Johnson officials with the Commissioner. The following copies are attached: Notice of Proposed Rule Making Asbestos Particles in Food and Drugs. Memorandum by S . Z. Lewin to G. Thompson of July 10, 1973, Final Analytical Report by S. Z. Lewin on Determination of Asbestos in Talc by X-ray Diffraction Key to Samples of Cosmetic Talc Products analyzed by S . Z . Lewin Summary and Comments on Analyses for Asbestos in Cosmetic Talc Products by H. J. Eiermann Results of Analysis of Johnson & Johnson Talc Products Evaluated by DCST Excerpts of Reports on Asbestos Studies Conducted on Johnson & Johnson Talc Products The only Johnson & Johnson sample that was implicated by Dr. Lewin in the asbestos controversy was #131, Medicated Powder. DCST could not confirm this finding in its analysis by optical microscopy. None of the J&J samples evaluated by Dr. Lewin demonstrated asbestos by this method. However, one sample which was apparently not tested by Dr. Lewin, Shower to Shower Powder, contained less than one per cent tremolite according to DCST analysis// Attachments Hemnz J. Eiermann December 12, 1973 RESULTS OF ANALYSIS OF JOHNSON & JOHNSON TALC PRODUCTS Analysis carried out by optical microscopy as described in Notice of Proposed Rule Making - Asbestos Particles in Food and Drugs (38 FR 27076) SAMPLE NO. 29 30 131 132 133 134 135 136 137 138 (1501Z) Code # PRODUCT Baby Powder Sample missing Medicated Powder Baby Powder Baby Powder Baby Powder Medicated Powder Shower to Shower Shower to Shower Shower to Shower Shower to Shower RESULTS Carbonate <1%; No Asbestos Carbonate <1%; No Asbestos Sample missing Carbonate <1%; No Asbestos Carbonate <1%; No Asbestos Carbonate <1%; No Asbestos Carbonate <1%; No Asbestos ; <1% Hematite? Carbonate <1%; No Asbestos ; <1% Hematite? Carbonate <1%, No Asbestos ; <1% Quartz <1% Carbonate; <1% Tremolite Il L John Stuart, Physical Scientist Special Investigations Section Product Composition Branch, DCST DCST T7 *i r m"T'C1 C s a n n ; xrl z. 1 2 / 7 3