94 Fulton.

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SECTION II.A

Report Entry No, 96 Sample No.

M IC R O - TALC IT EXTRA A verage T ech n ica l Data TB 185 E- 20 C h e m ical Analysis: S i0 2 Al2 0 3 6 2,6 % 0,2 % Fe2 0 3 0,1 % FeO 0,2 % CaO 0 ,3 % M gO 3 1 ,4 % CO2 0 ,4 % H2 O + 105C 4 , 8 % M atter v o la tile < 0,5% P a rtic le size d is trib u tio n by sed im e n ta tio n analysis: < 20 pm < 10 pm < 5 pm < 2 pm M ic ro - T alc IT Extra 100 % 99 % 85 % 40% TB 185 E- 21 P h /s ic o l dota Mean p a rtic le diam eter, pm 2 S pecific surface, N -a d s ., m / g W hiteness, tris tim u lu s f ilte r : amber F M X /C , % green F M Y /C , % b lu e F M Z /C , % Infrared re fle xio n , % O il absorption, g o i 1/100 g PH M a tte r so lu b le in w ater, % R e fra c tiv e index Hardness D ensity, g/ml Tam ped apparent density, g /m l Tamped volum e, m l.

- o * rtEAtt y DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration College Park, MD 20740 CAERS Disclaimer FDA's Center for Food Safety and Applied Nutrition's (CFSAN's) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse and product complaints that are allegedly related to CFSAN-regulated products.

101 1 buying a pig in a poke, you have to believe in the basic 2 integrity of the thing and in the observations and all kinds 3 of things, which you never do get to check, which is sort of 4 why the robustness of the findings and anything that can 5 make it seem less dependent on day-to-day differences adds 6 to the persuasiveness for me, and the things you cited, the 7 evidence of control group, the knowledge that there is 8 quality control in the system that generated the data, all 9 those things certainly help us. 10 CHAIRMAN BUNN: For the consumers on the 11 Committee, one of the things when the FDA approves an agent, 12 it allbws a manufacturer to market or advertise, you know, 13 their product, whereas, they are not allowed to do that 14 without the FDA approval. 15 Most of the time when a company comes in with an 16 extra indication, it is because they feel it is important to 17 advertise or market, and that has been the case in the past. 18 Now we have these new things where companies are just 19 denying drugs, saying, well, the FDA hasn't approved it, 20 therefore, we are not going to pay for it, and that is an 21 unfortunate thing that I think consumers and physicians, 22 even the FDA, as we have just heard, is really not in favor 23 of that type of approach to medical care. 24 DR.

HOW TO USE THESE SEPARATORS Use one page fo r each sep aration .

Pall offers users of process fluids in all parts of the world the broadest range of filter media available for solving fluid clarification problems.

32 Asbestos Air Pollution o Laboratory.

V-^ .v "Ti/C COSMETIC TALC Minerals of Interest The asbestiforrn minerals of primary concern in regard to cosmetic talc are fibrous serpentine (chrysotile) and fibrous amphiboles (tremolite and anthophyllite).

V-^ .v "Ti/C COSMETIC TALC Minerals of Interest The asbestiforrn minerals of primary concern in regard to cosmetic talc are fibrous serpentine (chrysotile) and fibrous amphiboles (tremolite and anthophyllite).

f DETECTION OF ASBESTIFORM AMPHIBOLE MINERALS IN COSMETIC GRADE TALC Introduction The method which has been adopted for the detection of amphi bole minerals in cosmetic talc is the generally accepted method of x-ray diffraction.

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 (15012) 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?

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