Document qmDyBg3aKZNXQMjweprnnVLmx
FILE NAME Talc TALC
DATE 1994 Nov 17
DOC TALC094 DOCUMENT DESCRIPTION Cancer Prevention Coalition Press
Release - Dusting with Cancer
CANCER PREVENTION COALITION
520 NORTH MICHIGAN AVENUE
SUITE 410
CHICAGO IL 60611
312-467-0600 ' FAX 312-467-0599
BOARD OF DIRECTORS
Ira Adook
Judith Brady Irwin Bross Ph.D Samuel Eastern M.D
Chairman Joy Feldman
Jock Geiger MD
Gillion Goodmon William Lijinsky Ph.D Thomas Mancuso M.D Perer Orns D
Ernest Sternglass Ph.D.
STAFF
Keith Ashdown Communications
Jill Cashen
Research Jan Kralovec
Director
Embargoed for Release
November 17 1994
Contact Keith Ashdown 312-467-0600
DUSTING WITH CANCER
COALITION URGES CHICAGO DRUG STORES TO LABEL TALC
Chicago - According to the Cancer Prevention Coalition the regular use of talc increases the risk of ovarian cancer The Cancer Prevention Coalition CPC will announce its plans for talcum powder labeling initiative here in Chicago at a Thursday November 17 1994 press
briefing
Speakers at the press briefing will include CPC Chair Dr. Samuel Epstein CPC board members Dr. Quentin Young and Dr. Peter Orris and an ovarian cancer survivor The speakers will explain why a labeling initiative is important to residents of Chicago and will also answer questions from the press
Recently CPC sent letters to the Chicago corporate offices of Osco and Walgreen drug stores urging that they provide customers with information on the dangers associated with the use of talc Additionally CPC is filing a petition with the FDA requesting that talc products be explicitly labeled
The use of talc poses a serious risk of ovarian cancer Estimates are that up to 17 % of
American women regularly use talc in the genital area Women have been compelled through advertisements of the cosmetic industry to dust themselves to mask odors Talcum powder has historically been a symbol of freshness cleanliness and purity is even more commonly used on infants
Ovarian cancer is a silent killer It causes 38 deaths daily among American women - totalling 14,000 deaths annually It is the fourth highest women's cancer death rate in the U.S. Over
60 of ovarian cancer victims die within five years of diagnosis
~
more
Cancer prevention throuthgrough h reduction of carcinogens in air water food consumer prevention
products and the workplace workplace
Studies seem to indicate that talc poses an increased risk factor for Ovarian Cancer thus I would support a warning label to alert women to this possible risk stated Diane Farrell a Chicago resident who has been fighting ovarian cancer for the last two years
According to Dr. Samuel Epstein of the Cancer Prevention Coalition A wide range of scientific studies over the last three decades have clearly linked regular talc use by women and
ovarian cancer
The talc labeling project is the first phase of a Consumer Labeling Initiative that will inform citizens of the presence of undisclosed carcinogenic ingredients and contaminants in cosmetics other consumer products and food and how to avoid them
WHEN Thursday November 17 1994 at 10:30 a.m.
WHAT Press briefing to announce the talc labeling initiative
WHERE Cancer Prevention Coalition 520 North Michigan Suite 410
PHOTO OPPORTUNITY CPC Board members ovarian cancer survivor products that contain talc and a poster size version of a proposed label
##
The Cancer Prevention Coalition is a Chicago national organization of leading independent experts on cancer prevention and public health together with citizen activists organized labor public interest and women's cancer groups
The New based Center for Constitutional Rights one of the nation's leading public interest legal organizations in the country will be acting as CPC's legal counsel
Citizen Petition Seeking Carcinogenic Labeling on all
Cosmetic Talc Products
17 November 1994
David A. Kessler M.D. Commissioner Food and Drug Administration 12420 Parklawn Drive Rockville MD 20857
Room 1-23
The undersigned submits on behalf of the Cancer Prevention
Coalition Inc. CPC Samuel S. Epstein M.D. Chair and National
Advisor of the Ovarian Cancer Early Detection and Prevention
Foundation OCEDPF Nancy Nehls Nelson member of the Ovarian
Cancer Early Detection and Prevention Foundation Peter Orris M.D.
and Quentin Young M.D.
This citizen petition is based on
scientific papers dating back to the 1960s which warn of increased
cancer rates resulting from frequent exposure to cosmetic grade
talc
The undersigned submits this petition under
361 362 and 371 a and 21 CFR 740.1 740.2
the Federal Food
Drug
and Cosmetic Act
Commissioner of Food and Drugs to require that
21 U.S.C. 321 n of 21 CFR 10.30 of
to request the all cosmetic talc
products bear labels with a warning such
cancer in laboratory animals
Frequent
as Talcum powder talc application
causes
in the
female genital area increases the risk of ovarian cancer
A. AGENCY ACTION REQUESTED
This petition requests that FDA take the following action
1
Immediately require cosmetic talcum powder products to
bear labels with a warning such as Talcum
cancer in laboratory animals
Frequent talc
powder causes application in
the female genital area increases the risk of ovarian cancer
2
Pursuant to 21 CFR 10.30 h 2 a hearing at which time
we can present our scientific evidence
B. Statement of Grounds
fourth deadliest women's cancer in the
Ovarian cancer is the
and killing approximately
striking approximately 23,000
difficult to detect
U.S.
Ovarian cancer is very
14,000 women this year
of the disease
making the
survival rate very be attributed
at the early stages
of ovarian cancer cases can
low Only three percent
risk factors for ovarian
to family history
One of the avoidable
area.
talcum powder in the genital
is the daily use of
cancer
6,7,8 1961 has shown that particles
Research done as early as
translocate from the
and asbestos particles can
similar to talc
in women
ovaries
These findings
exterior genital area to the
rate of mortality from
provide
support
to the unexpected high female asbestos workers
Minute particles
female
ovarian cancer in
translocate through the
talc
are
able
to
in the ovary
such as
tract
and
cause
foreign body reactions evidence
dating back
reprodTuhcetrieveis a large body of scientific
of cosmetic talc
the toxicity and mineralogy
on
thirty years
et al concluded
As early as 1968 Cralley
products
analyzed have
All of the 22 talcum products
19
The
fiber averaging
talc but
material was predominantly
fibrous
amounts of tremolite
contained minor
probably
and chrysotile asbestos
anthophyllite
in fibrous
fibers as these are often present significant
talc mineral deposits
that may
of such materials in products
amounts
may create an
be used without precautions
SEER Obstet Gynecol Cancer Statistics 1973-1990
cancer risk
to tale and ovarian
Welch WR Perineal exposure
2
BL Cramer DW Bell DA
80 19-
Harlow Ferrility Sterility 26 1992
tract
in the human female reproductive
The transport of carbon particles
GE Newton ..
Egli African Med I. particulate ovaries 12 151-155 1961
to the peritoneal cavity and
tracer from the vagina
radioactive
4 PF Iturralde M. Migration of
1979
Venter
55 917-919
demonstration
of tale from
The demonstration of migration
CG Griffiths K.
5
Hamilton TC Baylis MS Pierrepoint
40 247-250 1986 Research ,
WJ
in the rat Envizon
Henderson uterus to the ovary
vagina and posterior
workers Brit 1 Indust_Med the mortality of female asbestos
JC Turok ME A study of
6
ML Berry G. Wagner
/
Newhouse 29 134-141 1972
Industrial
Med 39 34-38 1982
Brit
the
Indust_Med
mask assemblers BK Fox AJ Mortality of female - gas 4
Hignall two E. Grime LP Mortality of
8
KD Gardner MJ Pippard
follow
Acheson and crocidolite asbestos a year
chrysotile
groups Brit J Ind
of women
Med 39
who manufactured 344-348 1982
gas
masks
from
2
unsuspected problem
Rohl et al examined 21
As a follow to previous findings including baby powders
samples
of
consumer
talcums
and powders
and pharmaceutical
powders
between
facial powders
body powders
I The study concluded
1971-1975 See Appendix
was
not
used
"
cosmetic
grade talc
...
in these products
exclusively The presence
and tremolite
of asbestiform anthophyilnldiitceates the need for
chrysotile and quartz
talc
standard for cosmetic
a regulatory
be made to
also
recommend
that
evaluation health
hazards
determine
the possible
with the use of these products
associated
the presence of
with or without
Talc is a carcinogen
National Toxicology Program
fibers
In 1993 the
talc and found
asbestos
the toxicity of asbestiform
published a study on
activity
clear evidence of carcinogenic
12,13,14,15 United States has found
research in the
in the genital
Recent cancer
talcum powder application
conclusively that frequent
woman's risk of
developing
ovarian cancer directly to
the
area
increases a al
suggested that talc application
lead to talc
Cramer et
time of ovulation mmight ight
genital area around the
of the ovary in the substance
parparttiiclcesles
becoming deeply imbedded reaction
granulomas
capable of
causing foreign body
and and perhaps
ovarian tissue
causing growth of epithelial
directly on the
that frequent talc use
Harlow et al found
W Kay MM Groch
Cralley I IndusetaInldusetal vane Assoc
DH 29
_ 10
AN Langer AM
Pohl characterization mineral and chemical
Selifoft
Lainhart WS Ligo RM
mineral content of cosmetic talcum
Fibrous and
350-354 1968
IJ
Tordini A Klimentidis _Toxical _Toxical Bova
R. Bowes DR Skinner Ol. Health 2 255-254 1976
studies of cale CAS
Consumer alcums
NM 14807-96-6 in
products Am and powders
F344 rats and
dearcinogenesis 5
Toxicology an
s
Toxicology Program
1993
N 42 September
Nacional studies Ical Ical por Seri
1983
Inhalation B6C3F mice
cancer letter A 250 1444
L. Tale and ovarian R. Lesher L. McGowan
cancer Synecal
7. Hoover
of ovarian
Hartze and the development
NB Mineral fiber exposure
KA Szklo M. Rosenshein
13Rosenblatt
M.
Personal 45 20-25 1992
Grosser S.
Jung DC
Ballon S. Hendrickson
tobacco
talcum powder
RS Sarles DL Kampert Ja
to
II Exposures
a Whittemore 14 AS Wu ML Pafferbergreerlated to epithelial ovarian cancer
and environmental characteristics
1118 1228-1240 1988
a Am J Spidemial alcohol and coffee
Harlow 1992
So 17 Cramer DW
:
4
376 1982
Welch wa
Scully RE
Wojciechowski Wojciechowski CA.
Ovarian cancer and
tale
50 372-
a case control study Cancer
increased a woman's risk threefold
area during ovulation
genital
That
study also
found frequent
method of
talc exposure was
the
The most
directly to
a dusting powder
use
as
Brand or generic baby
perineum genitals
and was the
used most frequently
powder was
with a statistically
associated
category
risk for ovarian cancer
significant
perineum.18 most comprehensive study of
In Harlow's report
arguably the
date 235
ovarian cancer cases
were
and ovarian cancer to
with no sign of
talc use
and compared to
239
controls
women
Through
personal
identified
related health problems
ovarian cancer or
found that 16.7 of the control group
Harlow et al
This
interviews
to the
frequent talc application
of women in the
reported
in estimating the number
is useful
percentage
cosmetic talc in the genital area on
general population Heaxrplooswed etto al concludes
a regular basis
prognosis for ovarian
" given the poor
harmful exposures
cancer any potentially
those with
should be avoided paFrotricultahirsly reason we
limited
benefits
hygiene
the use of talc in genital
discourage
as a daily habit
particularly
Clearly large numbers of women - an
the genital area and may
cosmetic talc in
from daily
of the risk of ovarian cancer
estimated 17 - are using
not be adequately warned
use
C. Claim for Categorical Exclusion
asserted pursuant to 21
exclusion is
A claim for categorical
CFR 25.24 a 11
that
to the best knowledge and
information
The undersigned certifies
includes all
of the undersigned this petition
and that it includes
belief
relies
views on which the petition
which
to the petitioner
and
and information known
data
representative
unfavorable to the petition
are
Harlow 1992
This petition is submitted by
520
Jill A. Cashen
Samuel S. Epstein M.D.
Cancer Prevention Coalition North Michigan Avenue Suite
Chicago Illinois 60611 312.467.0600 - phone 312.467.0599 - fax
410
of petitioner
ffiilllvall Signature of petitioner
11D/1a7t/e94l11/17/94
11-17-94 11-17-94
Date
Council to
Center for
Michael E.
the Cancer Prevention Coalition Constitutional Rights Deutsch Legal Director
666 New
Broadway York NY
10012
212-614-6427
APPENDIX I
of talc products in Chicago
Results from an informal survey drug stores
Baby Powders
Johnson & Johnson Baby Powder Johnson & Johnson Contains TALC fragrance
Skillman
NJ
Osco
Brand Baby Contains
Powder Osco Drug TALC fragrance
Oak Brook
IL
Body Powders
Jean
Nate Perfumed Talc Revlon New York NY
Contains TALC kaolin magnesium carbonate
fragrance
& Johnson Skillman NJ Shower to Shower Johnson
Contains TALC cornstarch sodium bicarbonate
polysaccarides
fragrance
Osco
Brand Body Contains
Powder Osco Drug Oak Brook IL
TALC cornstarch sodium bicarbonate
fragrance
polysaccarides
Medicated Powder Bristol Squibb New
Ammens
Contains Zinc oxide cornstarch fragrance
acid PPG methyl glucose ether TALC
York NY isostearic
Cashmere Bouquet Perfumed Powder Colgate
Contains TALC magnesium carbonate
fragrance
New York NY zinc stearate
Gold
Bond Medicated Powder Martin Himmel Hypoluxo FL
Contains
Menthol
Zinc oxide
boric acid eucalyptol thymol zinc
methyl salicylate salicylic acid TALC
stearate
Feminine products
Feminine Powder COMBE White Plains NY
Vagisil
Contains
Cornstarch aloe mineral oil magnesium
stearete silica benzethonium chloride fragrance
~
as.
-
Powder Schmid Laboratories Sarasota FL
Vaginex Feminine
6-
Contains Zinc oxide cornstarch fragrance
hydroxquinoline hydroxquinoline sulfate isostearic
PPG methyl glucose ether TALC
acid
Summer's Eve Feminine Powder CB Fleet Contains Cornstarch tricalcium
Lynchburg VA phosphate oxoxynol
benzethonium chloride fragraence
FDS
Feminine Deodorant Deodorant Spray Alberto Culver Melrose Park IL
Contains isobutane isopropyl myristate cornstarch mineral oil fragrance lanolin alcohol hydrated silica
magnesium stearate benzyl alcohol