..

~~

BABY PRODUCTS COMPANY
RARITAN. N.J. 08869

August 29, 1977

SUBJECT:

TO:

Status Report - Defense

of

Talc Safety

Mr. D. D. Johnston

Summary
There is apparent increasing opinion from independent
sources that normal consumer inhalation exposure to
cosmetic grade tales are unlikely to present a health
hazard. Authorities are recognizing compositional
differences between cosmetic and industrial tales.
The FDA-Cosmetics Division still expects to promulgate
future regulations for cosmetic tales.
brief status review of the talc safety defense program
is presented.

A

(). -

George Lee... / )
/by

Attachment

\

"

,:' ,
I ~
\./

Plaintiff's
Exhibit
J&J 73

J&J-0146266
Protected Document--Subject to Protective Order

JNJMX68_000013482

 Status Report -

Defens~ b~

Talc Safety

The past two months have seen no disruptive influences and
to the 'contrary, the cosmetic tales have enjoyed confirming
reassurance from several independent authoritative sources
that they are assessed to be free of hazard for normal consumer
use.
We attribute this growing opinion to the fact that (1) the
existence of CTFA's self-regulating cosmetic grade talc
specification has become common knowledge and that (2) favorable data from the variOUS J & J sponsored studies have been
disseminated effectively to the scientific and medical
communities in the U.K. and U.S.
Recent notable and important opinions relating to cosmetic
talc safety were the follOWing:
(1) NIOSH acknowledged the compositional differences
between cosmetic and industrial tales and reported
the presently mined Vermont tales to be free of
asbestos fibers.
(2) The OTe Misc. External Panel reaffirmed a Category I
. position for talc for safety and efficacy.
(3) Mr. J. Wenniger, Assoc. Director of Cosmetics
Technology, FDA, expressed his opinion at the NIOSH/
OSHA Asbestos Workshop that CTFA's self-regulating
action and the prevailing data lead him to conclude
that there are no problems with present cosmetic
talcum powders.
(4) A Lancet editorial reviewed talc inhalation and
concluded tha.t "there is no reason to believe that
normal consumer exposure to cosmetic talc has in
the past led either to cancer at any site or to
measurable loss of lung function.
It seems unlikely
that future exposure to cosmetic talc of the specifications now agreed to by major manufacturers. will
present a health hazard". .
The following represent current status of ongoing activities:
I. J & J Talc Data Generation
1. The Battelle in-vitro lung macrophage study has
progressed well and we expect their final report
in September.

J&J-0146267

Protected Document··Subject to Protective Order

JNJMX68_000013483

 -2-

Status Report - Defense of Talc Safety
D. D. Johnston
- - - - - - - - - - - - - - - - - -

-

-

2. The CTFA Round Robin retest of major powder brands
is incomplete.
operated.

3.

Mt. Sinai Laboratory has not co-

Windsor Minerals has initiated an employee health
monitoring program which will provide pulmonary
data for an ongoing prospective study.

II. Talc Scientific Publications
"Talc - Recent Epidemiological Studies"
by G. Hildick-Smith was pUblished in the proceedings,
"Inhaled Particles IV".
I I I . Non-J

1.

& J Talc Studies

Lovelace Foundation
The last quarterly report stated that no adverse
pathology has been observed, but that a very slightly
shorter, but statistically significant life span
has been noted with the talc exposed hamsters.

2. NIOSH Vermont Talc Workers
Still no reports forthcoming on their Mortality
and Morbidity studies.
3. OSHA-Vanderbilt Industrial Talcs

NIOSH have positively identified asbestos fibers
in the Vanderbilt tales.
Distinction between
industrial and cosmetic talc was emphasized at
the Asbestos Workshop.
FDA-Wenniger stated that
FDA still expects to promulgate cosmetic talc
regulations for the pur.pose of excluding the use
of industrial tales.

IV. BPC Product Strategy
1.

Product testing is still in progress with aged,
PEG-treated JBP and PEG-treated demicronized talc.

2.

The "living hinge cap" in the 9 oz. container has
been received for consumer testing.
Test will be
initiated shortly.

3.

Corn starch market test is still underway. Consumer attitude to corn starch is highly favorable,
with stated overall preference f(~tarch.

/by

y~

George Lee "

J&J-0146268
Protected Document··Subject to Protective Order

JNJMX68_000013484

 DISTRIBUTION

TO:

D. D. Johnston

Cc:

B. M. Deavenport
D. R. Petterson
R. C. Stites
E. West
R. S. Fine
B. Semple
J. R. Runnells
J. R. Marshall
S. P. Falk
R. N. Miller
H. Kramer
C----La.--Ros"a

"..

.:

.

-. -

P. Lonergan

J&J-0146269
Protected Document--Subject to Protective Order

JNJMX68_000013485