Document o9JaLG0awwvNGJkK3k8k7rymr
D EC 1982
Raymond J . Russell 121 Riverede Road Lincoln Park Hew Jersey C7035
Dear Hr. R u sse ll:
This replies to your le tte r dated October 15, concerning the presence o f needle-like p a rticles 1n ta lc containing baby powder and face powder which you believe may present a hasard sim ilar to one which exists fro the in halation o f asbestos fib e r s . You indicated 1n your le tte r that a micro scopic examination o f ta lc revealed that approximately 5 to 10 percent o f the p a rticles have a 10 to 20 micron, needle-H ke structu re, sim ilar to that o f asbestos.
The matter o f contamination o f ta lc with fibrous asbestos was extensively studied by both the Food and Drug Administration and industry in the sid e to la te 1970*$. Ve have no knowledge o f any cosmetic ta lc product on the market that contains fibrous asbestos. Hor do we have information or data which Indicates that presently marketed cosmetic t a lc preparations are un safe when used as directed. While we are well aware that t a lc is chem ically, clo se ly related to asbestos, we believe th at the needle-like p a rticle s that you have b r ie fly described in your le t t e r are ta lc needles, not fibrous asbestos. Talc needles are not known to cause bar or to present a hazard to health when t a l c containing baby powder and face powder are used under customary conditions o f use or as directed on th e ir la b e l. I f you have any s c ie n t ific evidence that the p a rticle s are not ta lc needles or that a hazard e x is t s , we would appreciate receivin g such information.
For your perusal, we are enclosing amimher o f documents which r e v f ewstthe
current sta te of otm knowledge r e la tin g to the health e ffe c ts o f t a l c and
asbestos, these 'documents' are a s fo llo w s:
, > !. L e tte r dated 1/11/79 Kennedy/Wol fe
;/2- "S a fe ty o f Consumer Cosmetic Talc Products* Journal o f Toxicology and Environmental Health 2:1221-1222 1977.
3. *Mineralogies! Characterization o f Cosmetic Talc Products* Journal o f Toxicology and Environmental Health 2:1223-1225, 1977.
4, 21 CFR 73.1550 - Talc
[/5. Federal Register document o f April 4 , 1975 Part 8.
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'Je thank you for your concents since i t Is often through observations made by concerned citize n s such as yourself that potential areas of concern are brought to our attention.
You can be assured that i f any cosmetic product offered for sale in th is country is found to be inherently in ju rio u s, the FDA w ill take appropriate regulatory action to remove such products frees consumer channels.
I f we can be o f any further assistan ce, please feel free to contact us.
Sincerely yours,
Enclosures: as stated above
Allen P . Hal per Assistant to the Director Division o f Regulatory Suidance
Bureau o f Foods
(b) (5)
Optical Microscopy: To determine fibrous tremolite, anthophyllite, and chrysotile.
Health Hazards
'
Asbestos: diffuse, nonmalignant scaring-of lungs.
Bronchogenic carcinoma:. malignancy of interior of lungs.
Mesothelioma: malignancy of lining of chest cavity (pleural) or abdomen (peritoneal).
Cancer of stomach, colon, rectum.
5-7 fold increase in lung cancer in asbestos workers, beginning 10-14 years after first exposure and significant after 20 years.