NEllORAWXIl·i OF HEET ING
---------~

July 8 , 1 971

..•
Representatives of Johnson & Johnsorr
Research Division., t~m.;r B:r.tn'i.:mick, N.Jo

Betv:een:

and
The Food arid Drug Aomini.stration
Asbestos Particles in Talc

SubJect:

The me.eting \vas h eld in Dr . Schaffner 's offiC'e in FB-8, 200 "C" Street,
··-S.\·1. ,-l<lashington, D.C. Nashed of Johrtson & Johnson

op <"~ned

the n•eeting by briefly reveiwing

recent events on the subject of asb estos particles in talc.

He in-

·dicated that the group present at the meeting from Johnson & Johnson
'

,would like to revie·.v the ana-l yt·i.cal .rrt.e.th.o.GcJ o.gy ou.

t....~e

det ection and

i
1

determination of asbestos particles in talc.

He indicated they would be

Jhappy to artS1¥er . any questions we had concerning methodology.
Dr. Shelly indicated that talc used in Johnson 1 s Baby Pov7der "ivas Ve rmont
talc obtained from their o1-m mines.
ation.

The mined talc is purified by flot-

This talc is incorporated into baby pm1der which h as the following

composition:
Tal c
Calcium Carbonate (a const:i.tuentof talc)
Sodium Citrate

0. 2% ( a buffe:r)

Perfu..'1le

0 .2%

l

Dr. Rolle showed photogre.pbs of ta lc obtained by use of an electron micro~·

Plaintiff's
Exhibit TP 83A
Kazan_FDA_FOIA 000149

 Page

scope at

soo~~

nt2gnificatic:1.

L1 thc::>l2 photograpbsJ corr;par.iscms

,,
4

\7er~ I<i.:tG·~

between Vermont talc used in Johnson'& products and samples of talc con-

taining 1, 5, 25 and 50% asbestos particles..
these photographs l ended additional

than 1%, i f G:ny, asbestos.

It '.;as their opinion that

~vidence

thct their talc contains less

Dr. Rolle was quick to point out that this

technique was not very reliable analytically.

Dr Nashed provided Dr. Schaffner w·ith th>:ee (3) copies of a report on the
analyses of Johnson 1 s Baby PDi.;rder and various se~les of VetT.10nt talc used

_ .in ...Tohnson 1 s Baby Po\·lder.

1.

This repoxt contained the following 3 parts.

June 2.4 1 1971, Report on Particle

Si <..~ <'~Lld

Shap e

Distributions of Grantha.'11, Italian, and Vermont
Talc Final Products for Johnson
Colo .~- ado

2.

& Johnson by

School of N.;.c1es Rese.c>.tch L .• stiLute.

July 7, 1971 1 X-ray analynes report on JOHNSON'S
Baby Pov]der sample 344-L, end six samples of
Verm:)nt Talc by Colorado School of H).nes Research
Institute.

3.

June 28, 1971, Report of x-r.ay exruaination of Talc
Products by Dr. R. C. Reynolds, Jr., Geology DGpt.,

Dartw.outh College, Hanover, New Hampshire.

Dr. :t\ashed noted that the information <md dat2 sub:rd. tted contains trade
secrets and is confidential and that FDA may not n.ake. it public without

written permission from th e

comp~lY•

Dr. Ca.nee'!:' then briefly discussed the contents of the repo rts submitted
and dl?.scriged the various nnalyticc:.l l.:oc!m5.ques u <-2d to cbtM_n the r eresults.
ported. The techniques us,;;d '"ere rui..r:::roscopic exm"lin2.tion (point counts
I\

Kazan_FDA_FOIA 000150

 P2ge
were made c;t 500x) and X-ray diffrac.:tion.
~ould

Dr. Caneer

h~dicated

3

th.:1t he

send the details of the procedures used to Dr. Schaffner in the

near future.

Dr. Caneer then described the result s from X- ray diffraction examina tion
of Vermont tal c .

These results indicated th2t. this talc contains essen-

tially no anthophyllite and only minor atnounts (belmv 17~) of tremoli.te
and actinolite, or i n other i-Jords contains less than 1'7,, if any, asbestos

pe:rticles.

Dr. Caneer \..ras confident that X-ray diffract ion would

de~::ect

mo st mineral foL:mS of asb estos at a level of 1%.
Dr. Shelly i ndicated that vJithin the next f ew >·7eelcs Johnson and .Johnson
-.;.;ill have analyses of Vermont to.lc from an additional 3 or 4 independent

laboratories.
Dr. Snuth then reviewed some of the medical ·reports in the literatu r e

about asbestos.

He irtdicated that the presence of asbe stos to th e ex-

tent of 5% by weight gave rise to medical problems in industrial u orkers.
He then outlined the type of future testing t hat -.;.;auld be c a rried out by

Johnson and Johnson.
Those attending from i ndu stry were :

R.F. Rolle, Ph.D.

Laboratory Supervisor

Johnson & Johnson
Resea rch Division
He'<l Brunswick, N.J.

089 03

Division of Science
Information
JJ
T. H. She1. ley} Ph.D.
~-

G. H. Smith, li.D.

Director, Researcl1
Dept.
JJ

Director o£ Clini.cal
Re.se'"rc h
JJ

Kazan_FDA_FOIA 000151

 . r·-.,..

Page

4

. . ._,
'J~

T. Caneer
Asst. Hanger, Hining Division
(Consultant for J. and J.) Colorado School of Hines
Research Institute
Golden, Colorado 80401

From FDA:

R. N. Schaffner, Ph.D.
C.

3;

Kokoski, Ph.D.

Director
Office of Technology
Division of Toxicology

H. R. Gittes

Division of To::.:icology

S. H. Newburger, Ph.D.

Division of Colors & Cosmetics
Technology

J. A. Henninger

Division of Colors & Cosmetics
Technology

'I}. V. Eisenberg

Division of Hicrobiology

R. E. Newberry

Division Case Guidance

//) / ..,

7

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j.! -r :/ .:c.-r,.,·Y'"'-1'/c..;---

--·

I'

'

1

John A. Wenninger
'
'fossistant Chief, Cosmetics Branch
/ Division of Colors & Cosmetics

~-

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