ToilHry and FragranceAssociation,Inc.
The Cosmetic,
";",.mu" H

/I..?

::rr:H

..

Pns

.. d·.-

..

,r

Norman F. r.·,lr;n Qh.O.
..

v-ee Pr,?, 'e.:

-

....

SI..;f'?I!.:(

March 15th, 1976
Heipz J. Eiermaml
Food and Drug Administration

.!olr.

200

C

street,

S. H

..
D.C. 20204

Was?ington,
On

March 11th, 1976, Mr. Eiermann

__

the CTFATalc Subcommittee

m?::

-to discuss

l:he

curr,=nt

st3.-

i:rinq

need exists
recognized that
tus ·oftalc. It was
f?r asbestos form
a
analyses
t?e
of
profile
to your attention
r odu c t i
p
on ,:,f cos;net!.cs
materials in talc used in the U.S.
and toiletry products.
a

t.o

I·
,

of i"1.J('.stry
resp,'msibil:'·'?:!
The attached letters demonstrate
"ill
We a r e cc>ct'lin that. the S'lIl'_'1-,ary
in. monitoring its talcs.
bI
c:'rrllTtC0nt2.miClatL',,·
freedom
giveyali assurance as to. theoo sme t.i.c t,'10 ptoducts.
asbestos form materials of
to disCllSS
Individ'>a1 companies ·aremorethan ,,,il1inq
dct.ailed data with you at your convenience-

t?le

Cordially, ?

cY;7???--%$.fl?f<f}?C:;;;::-·

.?

..

Norman
F. Estrin, Ph.D.
Scipnce
Vice President
-

NFE:jj·
Attachments

Plaintiffs'
Exhibit
2974

 BABY PRODUCTS COMPANY

NEW BRUNSW;CK.

.

;\/

J

OB??(l3

March 15, 1976

Dr. NormanF. Estrin
Science
Vice ,Pre,sident
-

Co sme t

i

c

,

TOiietrtes,,' and

Fragrance Association
1133 15th Str?eti rt:W:
Washington, D.C. 20005
Re:

Dear Dr.
The

its

for Asbestos

Examination

In Talc

Estrin:

used by Johnson &. Johnson is solely dEori ved. from
and
where the ore i,smined selecthely
own mine in Vermont,

ta Lc which is

then:benefi0iated
Shipments

of

t hi

by the process

shighly

our own lalJorato;t-yto

pur i.f'Led

verify the

of flot?tlon,

ex?min'?ct

talc are rOirtinely
ILDs<"nc,E'

b,V

rineral",

of asbestos

d
"hE'
e
Johnson has alwaysbr.i>n co nc ruv ab·)ut
e c i
sp
t a 10sand ev?n its, ea:rliE>st
mineralogical integrity of its,
for acicuJarpart.icul,itc>s,.
t
ficlltjonShave required theexamjil?tion
1971
t.na+ o u r powder con a.Lncd
in
When it was errollE'ouSly'reported
9 rid
t
c a I
f
r
a
n
log
nri ne
a
seien t Lf Lc R<cminar
asbestos, we, sponsored
not
cnnFDA to, prQVE- that our talc is
ana Ly t Lca.l oxpor-t s for the
we::-'r ou s
sn.!:mle",
At that tim" nurne
taminated with'ashest,os.
as '?kCrone' AssOCcat"R.
such
Lt
an
corisu
ts
s
analyzed by, experienced
Poo Le y (.;,f1: h'? Uni ve r it,:
Colorado School of Mines, Profestior F. n.
and PrQieSS0T

Historically,

Johnson,

&,

'

«

,

'

nCPWI1'1
Cardiff) ,Professor G. Brown (of Prj
X'-ray d1ffracTheseexaminatinnsittclu<:!e<:!
('?cctron
M,Buerger (of M.,LT.).
and
h'ansmission
tionanalysis,. differential' thermal analysis,
"

College,

'

'

.

microscopy.
t ndf.1972 toOctobf'T 1973, a3 lots WH"
During, the period Decemher
for the Pr"'SPrjce
by X-ray diffra?tometry
vidually sampled and examined
we ro
minerals
s()rpentine
No amphiboles or
of asbestos minerals.

detected'in

any

sample.-

I
.

,

 Dr. N. F. Estrin
C.T.F.A.

Beginning

to

in October 1973, differentiald

&;pecifi0d requirement;

our'

x-ray

and

Mar'ch

app

Both,

.thermal. anaLysrt s "as added
Lf f e r en t.La L thernml ana Lvs La

instituted for the r-ou t Lne E"xatJiin"t.idn
further 100 lots have since been exar.;inpd,

dd f f r-ac t.ome t r y
A

tial
of sequel!
l y I ng both

.

15, 1976

lots...

we-r-e

to

methods

e

a.ch sample.

Ag a Ln

,

no amph+bo J.e ''1' o."r-

beeft.detected.

pentirie mil!erals.have

are continuing to employ differentiaL·
arid X-ray diffrac t ome t r y in t.he examinat ion of
sequential lots for' the detection of amphibole andserptntine minwould like to
thermal. analysis

I

ad"i". that

we

erals.
t a t n a worldwi(te· n.on I taring
hou Ld be pointed out tha.twe a] ,;0 maf.n
& ;Johnson
affiliates, omp LovLng these
of tales used by otir Johne.on
same teChniques.

It

s

let me
Transmission

Fihn.lly,

for

always

It
to

is

verified

our'

we also suhmit
d
n
exarru
?lierosc.op6
at it'n an
Electron
o
the absence 0i' asbest Lf rm r.ri ner-a.Ls

add

t

P'Le

sub=s amp Le s

these

h

a v e

.

i
you would wi.s h to subm t vt.h i.s infc.rm&.tlon
s
regard thl lEitt(;r as IlOll-c.onfidt'ntiJ.1.

understanding

the FDA;

periodically,

ha t

a

s-e

t

na t

Sincerely ! yours.
,

',\."

George Lee

Direetor of Appli?d
GL/nun

ReSE.'CTCh