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Subject:

Talc/Asbestos
Meeting with Commissioner Schmidt,

Brunswick,

NJ.

January 18, 1974
'

FDA

January H3, 1974
Memo

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Attendees:

for F DA ;

D r. V.
Dr. H.

Wodicka,Director, Bureau

of Foods
Division of Cosmetics

Director,
Technology.
Mr. J. Wenninger, Deputy Director, Division
Cosmetics Technology.

of

Later: Commissioner Schmidt and the above.
for J&J:

Dr. R. Fuller, Dr. G. Hildick-Smith, Dr.W.Nashed

A

p r e l i m i n a r y meeting w i t h D r. Wodicka and his staff was
held.
We t r a c e d the history of the
talc/asbestos problem: Kretchmer
letter; F DA Symposium, August, 1971,
where Mt. Sinai people
croscopy of our
product was wrong and that Johnson &
Johnson Baby Powder was
the best talc available; and we mentioned the
voluminous data which
we had shared with the FDA,
D r, Eierrnann and M r, Wenninger
corroborated our p r e s e n t a t i o n s to D r ;
Wodicka.

Dr. Eiermann then said that he has reviewed the CTFA
Round-Robin
test results with his microscopist,
Mr. Schulze, and said that
Mr. Schulze still thinks the method is valid. We pointed out that w e
believe that the method has some basic flaws as outlined in the C T FA
comment; however, we believe that a c o o p e r a t i v e
program between
FDA and industry should result in a
practical solution to the problem.

*

F o r m e r J’&J employee in

Brazil.

Plaintiff's
Exhibit
2456
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2045

We pointed out that we had developed a
DTA method capable of
measuring 1% chrysotile and we also believe that a step scan x - r a y
method can be used to detect 0. 2% trernolite-

Dr. Eiermann said that they have obtained DTA equipment and
x-ray equipment and that he has some reservation about allowing
1% chrysotile.
We volunteered to c o o p e r a t e with his
scientists in the development
of the method fo r DTA and p r o m i s e d to provide a copy of a
proposed
publication regarding this method.

Dr- Eiermann said that his main interest
what level of dust exposure occurs in the
and that they would like

a t this time is to find
p ro c e s s of dusting a baby

to use the data to calculate allowable
asbestos using 5 f i b e rs per ml (OSHA limit) for
safe exposure in
the mines.
We promised to provide a r e p o r t on the talc dust
ex p o s u r e of babies.
We pointed o u t that the data we have is based
on exaggerated dusting of a whole can of baby powder and that the
a m o u n t generated, namely 345 mg/ _
m3 may be excessive. We said
that we are currently attempting to make the same
calculation he
proposed to the data. Our very preliminary
calculation
indicates that substantial asbestos can be anowed. safely in a baby
Dowder.

Dr. Wodicka appeared skeptical of D r. Eierrnann's approach

to the
problem. He implied that what is safe for a miner may n o t be safe
for a baby.

E i e r m a n n also mentioned that they w e r e
carrying o u t some
studies in-house using an air sampler to
assess the dust exposure
and were having some difficulties in
determining it.

Dr. Hildick-Smith

reviewed the c u r r e n t knowledge on the
biology
of talc and indicated that talc had a low
order of toxicity when
evaluated in cell culture s y s t e m s , that animal studies had been
conducted which confirmed the cell culture studies, and that longrange inhalation studies in r a t s by MRC and in hamsters by .]’&.I
were being conducted in England and in the U,S_A_'. and that the
results will be available in 1975. It was pointed o u t that t w o s e p a r a t e
epidemiological studies had been conducted on talc miners,
one by
D r. Kleinfeld and the other by Dr. Green at the University of
Vermont
School of Medicine i n Burlington. The data
obtained from both studies
indicated that, where miners in the Kleinfeld study had been
exposed
to talc dust for an average of about 17 years and in
the Green study
for about 7 years, there a p p e a r e d to be no significant impairment
of
the miners’ health. Utilizing these data, the known information

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January 18, 1974

concerning the a m o u n t of tale to which infants were exposed and their
respiratory capacity, miners were exposed for a period of approximately
I, 000 times that of an infant. The
dose respired by the -miner is
approximately 11, 000 times that respired by the infant. It was brought
o u t that critical review of
all the world literature failed to show any
evidence of adverse health effects following the normal use of cosmetic
talcs.

{.

Dr. Hildick-Smith indicated

that he was writing a review ar ticle on talc
and that a copy of the manuscript would be sent to
the FDA for their

files.

F u l l e r stressed Johnson 8: Johnson's
policy of full cooperation with
FDA and that if the results of any
scientific studies show any question
of safety of talc, Johnson 8: Johnson will not
hesitate to take it off the

Dr.
2

market.

A meeting was then held in Dr. Schmidt's
office. The proceedings
were similar to that which took place in Dr. Wodicka's office
.

Dr. Schmidt asked for information on our Vermont mine: location
(Windsor, V t . ) , kind of talc (platey talc), processing ( f r o t h flotation
to maximize platey talc).
He wanted to know whether we s e l l our talc
to o t h e r companies (cosmetic beneficiated
grade is not sold to other
companies; other locations in the Windsor mine are used to supply

industrial grade talc).

Dr. Fuller pointed o u t that our meeting is not a "crisis" meeting.
The Commissioner appeared to appreciate
that. Dr. F u l l e r again
stressed Johnson 8: Johnson's pplicy of full cooperation
with the FDA
which preceded the Kretchrner incident, namely, the Tenovus r e p o r t
where Dr. Hildick-Smith had called
Dr. Simmons at the time we first
heard of it. We reviewed briefly the Tenovus data (unreliable
talc
par ticle identification technique, presence of mineral
particles in
the tissue-fixing baths, lack of formal
education of the p r i n c i p a l
investigator).

Dr. Hildick-Smith also commented briefly

on the ar ticle relating stomach
cancer in the Japanese and pointed out that this
was generally discredited
by scientists and that there was no information in the world literature
o r in animal studies completed to
indicate talc produced

cancer.

Dr. Schmidt said that the FDA could come under p r e s s u r e - f r o m
consumer
o r other groups and that they
were particularly vulnerable when there
were m i n i m a l , inadequate
no
or

had,

scientific data in a specific

area.

He

however, developed a tactic by which he publishes in the Federal
Register any scientific attack on the F DA in the hope that members of
the scientific community could provide data to assist the F DA ,

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January 13, 1974

He

a p p r e c i a t e d the
Johnson 8: Johnson visit and our e x p r e s s i o n of
interest to assist the FDA where possible.
He welcomed the opportunity
of having a
of scientific
source
on which he could rely if
information
the occasion
arose. He indicated the immediate interest of the FDA
in developing a method fo r
assessing asbestos in talc.. He pointed out
that additional information being developed
by Johnson 3: Johnson

KN’ N
W. Nashed
CW

cc:

Dr.
D r,

R , A. Fuller
A. Goudie

Dr. G. E-Iildick-Smith
Mr. D. D. Johnston

Mr.

Dr.
Mr.

G.
D.
S.
T.

Lee

Petterson

Smoyer
D r,
Shelley
M r. H. Stolzer

J8-J-0132011
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