Unabhngige pharmazeutische Zeitschrift fr Wissenschaft und Praxis Sonderdruck aus Heft 22 112.

SY 941 PA December 19, 1973 Hearing Clerk Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville, Maryland 20852 .

UNITED SIERRN B O X 1201 T R E N T O N , NEW J E R S E Y 08606 DIVISION CYPRUS MINES CORPORATION T E L E P H O N E 609*883-5111 TWX 510*685-9585 December 21, 1973 Hearing Clerk Food & Drug Administration Room 6-86 5600 Fishers Lane Rockville, Md. 20852 Subject: Asbestos particles in Food and Drugs, the subject of proposed rulemaking of the Food and Drug Administration, Federal Register, Vol. 38, No. 168, 9/28/73, (21 CFR P arts 121, 128 and 133) Dear Sir: As a. major talc producer, this division is vitally concerned with this subject.

THE UPJOHN KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 COMPANY May 20, I976 OHfAfiRcReYofR ALLEN, M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-65 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In compliance with the Federal Register Notice, Volume Lo, Number 51, March lL, 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenteral Injection", we are supplying the attached memo as an updated report for replacement of asbestos filters.

COLGATE-PALMOLIVE COMPANY 909 River Road Piscataway, N.J. 08854 Norman F.

MEMORANDUM oe . _^<- DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION T O George H.

ifetrch 5, 1973 M$* liarjorie &*K* Inservice Education Coordinator Edgamoor Geriatric hospital Horth Mgemoor Drive Santee, California 92071 Dear He* Briggsi Vour letter o February 6, 1973 to the attention of the Food and Drug Administration hm been referred Iso me for reply* We are at present cxapilta$ information on various talc products, but this is not yet ready for release* Inhalation of large rraomat of eshastee, a# in occupational exposure, is kno&tt to increase the incidence of lung cancer and pwseothelfossa, e&peeially in heavy sobers of cigarettes* Aabeafcos is often found- as a. natural contaminont of talc; both are magnesium silicates, end aro geochemicalXy Infcercoarvcriifele* Taleoei* if seaa only tmder conditions of heavy exposure and talc has not been demonstrated of itself to bo careino^onic* the levels of the various types of asbestos found in talc vary depending upon the source frm. which the talc comas, and: the use for Which it is intended, i.s* ties in heavy Industry, food UqpmUmdt, cosmetic* Generally* the bat-tar grades of commtc and food talcs are reportedly free of ae~ bastes* Iveadlcss to- ay, the suppliers and cotaaercial users of talc are aware of the potential problems presented cad in the last year or so the industry lias made an effort to reduce or eliminate asbestos in talc as required* Two statements from 1971 report on Asbestos by the national Acatoay of Sciences are of interest there are levels of asbestos exposure that will not he associated vlth any detectable risk.

INSTRUCTIONS FOR INSERTION OF "COSMETIC TALC" STANDARD INTO CTFA STANDARDS Attached are: 1.

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C olorado School of M ines R esearch P.O.

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FILE NAME: Talc (TALC) DATE: 1972 Apr 13 DOC#: TALC062 DOCUMENT DESCRIPTION: Letter to FDA from Barry Castleman April 13. 1972 Division of Colors and Cosmetics Office of Product Technology Food end Drug Administration Washington.

FILE NAME: Talc (TALC) DATE: 1972 Apr 25 DOC#: TALC065 DOCUMENT DESCRIPTION: Letter to FDA from Barry Castleman AptiX SJ 3$n m m M* $ ( # .a.

- -rl VjL ,iVi / A rAi lT\nT DEPARTMENT OF HEALTH, EDUCATION, AND WELFAR PUBLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION TO : Henry E.