New Brunswick, N. J.
April 9, 1969

SubJect: Alternate Domestic Talc Sources
File No. 101

Dr. G. Hildick-Smith

Pete, we have to firm up the position the Company should have on the presence of the mineral
Tremolite in talc. Your staff will have to do
this for us since the objections to that mineral
have been mainly medical or clinical as opposed
to chemical or physical.
The reason we have to firm up our position is
that we have moved into high gear on some alternate talc sources and it is normal to find
different levels of Tremolite in many U.S. tales.
We are looking at some of those.
Historically, in our Company, Tremolite has been
bad because it has needle type crystals. Our
position has been that these can stand on end,
penetrate the skin! and cause irritation: consequently, talcse'x~ceetding)trace contents have
never been approved. Over the past year or two,
the medical literature has made reference to
potential hazards of talcs containing Tremolite
and I have seen some articles under the umbra
of environmental health agencies from here and
abroad which pinpoint severe objections to that
mineral in talcum powders.
Unfortunately, Tremolite has different varieties
and can be easily confused with other members of
the mineral class into which it falls. Chemically, it is mainly a calcium silicate with
varying amounts of magnesium silicate and sometimes it carries iron with it in minor amounts.
Some varieties of it match asbestos, and I gather there
has been a lot of attention given to the hazards
of inhaling minerals of that type lately.

Plaintiff's
Exhibit
J&J 202

Protected Document--Subject to Protective Order

JNJAZ55_000001073

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There is nothing we can do about the confused
state of affairs on Tremolite from the mineralogical and chemical points of view as far as
historic literature is concerned.
The question is .•. How bad is Tremolite medically,
and how much of it can safely be in a talc base
we might develop?

fAf-IIlJ
H. Ashton

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New 8runsw'clc, N. J.
SuIJ'ecf: ALTERNATE DOMESTIC TALC SOURCES

April 15, 1969

Project Code #101

Mr. W. H. Ashton:
Your inquiry of April 9th, 1969 addressed to Dr. G. Hildick... Smith has
been referred to my attention for reply.
Over the years, I have reviewed the literature on the hazards relating
to the inhalation of talc particles on several different occasions. In
your memorandum, you indicate that Tremolite does have needle-type
crystals and that our position has been that these could penetrate the
skin and cause irritation. Actually, to the best of my knowledge, we
have no factual information on this subject. It would seem logical that
it could occur, although whether or not it would be of clinical
significance would be conjectural.
We have been concerned to a much greater extent with regard to
possible dangers relative to the inhalation of the talc with a spicule or
needle-like crystalline structure as compared with the flat, platelet..
type of crystalline structure. There are reports in the literature
concerning talcosis which, as you know, is a form of pneumoconiosis
attributed to the inhalation of talc. Reported studies have suggested
that this does not occur in connection with the flat, platelet-type of
talc, but does occur in connection with the spiculeetype of crystalline
structure characteristic of Tremolite. The reported instances have
been extremely few but have, without exception, involved inhalations
of high concentrations on an occupational basis of many years duration.
Furthermore, we have occasionally received inquiries from various
individuals, including General Johnson and several pediatricians,
expressing concern over the possibility of the adverse effects on the
lungs of babies or mothers who might inhale any substantial amounts
of our talc formulations. In the past, we have replied to the effect
that since our talc is essentially all of the platelet-type of crystalline
structure, and is of a size which would not be likely to enter the
pulmonary alveoli, we would not regard the usage of our powders as
presenting any hazard. Obviously, if we do include Tremolite in more
than unavoidable trace amounts, this sort of negation of such inquiries
could no longer pertain.

Plaintiff's
Exhibit
J&J 195

Protected Document--Subject to Protective Order

JNJNL61_000001534

 I

.. 2 April 15th, 1969

Mr. W. H. Ashton

Upon various occasions we have discussed the possibility of carrying
out studies on animals which might provide factual information with
regard to whether or not variable exposures to talc suspended in the
environmental atmosphere might be productive of fibrotic and/ or
inflarrunatory reactions in lungs. For a variety of reasons, the se
have never been carried out here.
Since pulmonary diseases, including inflarrunatory, fibroplastic, and
neoplastic types, appear to be on the increase, it would seem to be
prudent to limit any possible content of Tremolite in our powder
formulations to an absolute minimum. To the best of Uly knowledge,
we have never been faced with any litigation involving either skin or
lung penetration by our talc formulations. Some years ago, we were
faced with a more or less serious problem resulting from what we
consider to have been an unjust accusation of danger due to the
presence of a small amount of boric acid in our talc. This created
such a furor that we were more or less compelled to remove boric
acid froUl the forUlulation. It is conceivable that a similar situation
might eventually arise if it became known that our talc formulations
contained any significant amount of Tremolite. Since the usage of
these products is so widespread, and the existence of pulmonary
disease is increasing, it is not inconceivable that we could become involved
in litigation in which pulmonary fibrosis or other changes might be
rightfully or wrongfully attributed to inhalation of our powder formulations.
It might be that someone in the Law Department should be consulted
with regard to the defensibility of our position in the event that such a
situation could ever arise.
It is Uly personal feeling that until we have at least substantial evidence,

based on animal work, to the effect that the presence of Tremolite in
our talc does not produce adverse effects, we should not extend its
usage beyond an absolute miniInmn previo7L:J;:tiOned.

T.

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M. D.

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R. A. Fuller
Gavin Hildick.. Smith
W. J. Ryan
G. H. Lord
J. E. Willson
J. Bothwell

Protected Document--Subject to Protective Order

JNJNL61_000001535