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November
17, 1994
David
A. Kessler, M.D.
Commissioner
Food and Drug Administration, Room 1- 23
12420 Parklawn Drive
Rockville, MD 20857
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 21 U.S.C. 321 (n), 361,
362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the
Federal Food, Drug, and Cosmetic Act to request the Commissioner
of Food and Drugs to require that all cosmetic talc products bear
labels with a warning such as Talcum powder causes cancer in laboratory
animals. Frequent talc application in the female genital area increases
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 powder causes cancer in laboratory
animals. Frequent talc 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
Ovarian
cancer is the fourth deadliest women's cancer in the U.S., striking
approximately 23,000 and killing approximately 14,000 women this
year. Ovarian cancer is very difficult to detect at the early stages
of the disease, making the survival rate very low. Only three percent
of ovarian cancer cases can be attributed to family history. (1)
One of the avoidable risk factors for ovarian cancer is the daily
use of talcum powder in the genital area. (2)
Research
done as early as 1961 has shown that particles, similar to talc
and asbestos particles, can translocate from the exterior genital
area to the ovaries in women. (3,4,5) These findings provide support
to the unexpected high rate of mortality from ovarian cancer in
female asbestos workers. (6,7,8) Minute particles, such as talc
are able to translocate through the female reproductive tract and
cause foreign body reactions in the ovary.
There
is a large body of scientific evidence, dating back thirty years,
on the toxicity and mineralogy of cosmetic talc products. As early
as 1968, Cralley et al. Concluded:
All
of the 22 talcum products analyzed have a ...fiber content...averaging
19%. The fibrous material was predominantly talc but probably
contained minor amounts of tremolite, anthophyllite, and chrysotile
[asbestos-like fibers] as these are often present in fibrous talc
mineral deposits...Unknown significant amounts of such materials
in products that may be used without precautions may create an
unsuspected problem. (9)
As
a follow-up to previous findings, Rohl, et al., examined 21 samples
of consumer talcums and powders, including baby powders, body powders,
facial powders and pharmaceutical powders between 1971-1975. The
study concluded:
...cosmetic
grade talc was not used exclusively. The presence in these products
of asbestiform anthophyllite and tremolite, chrysotile, and quartz
indicates the need for a regulatory standard for cosmetic talc...We
also recommend that evaluation be made to determine the possible
health hazards associated with the use of these products.(11,10)
Talc
is a carcinogen, with or without the presence of asbestos-like fibers.
In 1993, the National Toxicology Program published a study on the
toxicity of non-asbestiform talc and found clear evidence of carcinogenic
activity (11).
Recent
cancer research in the United States has found conclusively that
frequent talcum powder application in the genital area increases
a woman’s risk of developing ovarian cancer (12,13,14,15).
Cramer,
et al, suggested that talc application directly to the genital area
around the time of ovulation might lead to talc particles becoming
deeply imbedded in the substance of the ovary and perhaps causing
foreign body reaction (granulomas) capable of causing growth of
epithelial ovarian tissue (16,17).
Harlow,
et al, found that frequent talc use directly on the genital area
during ovulation increased a woman’s risk threefold .
That study also found:
“The
most frequent method of talc exposure was use as a dusting powder
directly to the perineum (genitals) . . . Brand or generic ‘baby
powder’ was used most frequently and was the category associated
with a statistically significant risk for ovarian cancer.”
In
Harlow’s report, arguably the most comprehensive study of talc use
and ovarian cancer to date, 235 ovarian cancer cases were identified
and compared to 239 controls, women with no sign of ovarian cancer
or related health problems. Through personal interviews, Harlow,
et al, found that 16.7% of the control group reported frequent talc
application to the perineum (18). This percentage is useful in estimating
the number of women in the general population exposed to cosmetic
talc in the genital area on a regular basis. Harlow, et al, concludes:
“.
. . given the poor prognosis for ovarian cancer, any potentially
harmful exposures should be avoided, particularly those with limited
benefits. For this reason, we discourage the use of talc
in
genital hygiene, particularly as a daily habit.”
Clearly,
large numbers of women—an estimated 17%—are using cosmetic talc
in the genital area and may not be adequately warned of the risk
of ovarian cancer from daily use.
C.
CLAIM FOR CATEGORICAL EXCLUSION
A
claim for categorical exclusion is asserted pursuant to 21 CFR 25.24
(a) (11).
D.
CERTIFICATION
The
undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views
on which the petition relies, and that it includes representative
data and information known to the petitioner which are unfavorable
to the petition.
This
petition is submitted by:
Jill
A. Cashen
Samuel
S. Epstein, M.D.
Cancer
Prevention Coalition
Michael
E. Deutsch, Legal Director
Center
for Constitutional Rights
REFERENCES
1.
SEER Cancer Statistics, 1973-1990.
2.
Harlow BL, Cramer DW, Bell DA, Welch WR. “Perineal exposure to talc
and ovarian cancer risk.” Obstet Gynecol 80:19-26, 1992.
3.
Egli GE, Newton M. “The transport of carbon particles in the human
female reproductive tract.” Fertility Sterility 12:151-155, 1961.
4.
Venter PF, Iturralde M. “Migration of particulate radioactive tracer
from the vagina to the peritoneal cavity and ovaries.” S African
Med J 55:917-919, 1979.
5.
Henderson WJ, Hamilton TC, Baylis MS, Pierrepoint CG, Griffiths
K. “The demonstration of migration of talc from the vagina and posterior
uterus to the ovary in the rat.” Environ Research 40:247-250, 1986.
6.
Newhouse ML, Berry G, Wagner JC, Turok ME. “A study of the mortality
of female asbestos workers.” Brit J Indust Med 29:134-141, 1972.
7.
Wignall BK, Fox AJ. “Mortality of female gas mask assemblers.” Brit
J Industrial Med 39:34-38, 1982.
8.
Acheson ED, Gardner MJ, Pippard E, Grime LP. “Mortality of two groups
of women who manufactured gas masks from chrysotile and crocidolite
asbestos: a 40-year follow-up.” Brit J Ind Med 39:344-348, 1982.
9.
Cralley LJ, Key MM, Groth DH, Lainhart WS, Ligo, RM. “Fibrous and
mineral content of cosmetic talcum products.” Am Industrial Hygiene
Assoc J. 29:350-354, 1968.
10.
Rohl AN, Langer AM, Selifoff IJ, Tordini A, Klimentidis R, Bowes
DR, Skinner DL. “Consumer talcums and powders: mineral and chemical
characterization.” J Toxicol Environ Health 2:255-284, 1976.
11.
National Toxicology Program. “Toxicology and carcinogenesis studies
of talc (CAS No 14807-96-6) in F344/N rats and B6C3F 1 mice (Inhalation
studies).” Technical Report Series No 421, September 1993.
12.
Hartge P, Hoover R, Lesher LP, McGowan L. “Talc and ovarian cancer.”
Letter. JAMA 250:1844, 1983.
13.
Rosenblatt KA, Szklo M, Rosenshein NB. “Mineral fiber exposure and
the development of ovarian cancer.” Gynecol Oncol 45:20-25, 1992.
14.
Whittemore AS, Wu ML, Paffenbarger, RS, Sarles DL, Kampert JB, Grosser
S, Jung DL, Ballon S, Hendrickson M. “Personal and environmental
characteristics related to epithelial ovarian cancer. II. Exposures
to talcum powder, tobacco, alcohol, and coffee.” Am J Epidemiol
1128:1228-1240, 1988.
15.
Harlow, 1992.
16.
Ibid.
17.
Cramer DW, Welch WR, Scully RE, Wojciechowski CA. “Ovarian cancer
and talc: a case control study.” Cancer 50:372-376, 1982.
18.
Harlow, 1992.
APPENDIX
I: Results for an informal survey of talc products in Chicago
drug stores.
BABY
POWDERS
Johnson
& Johnson Baby Powder. Contains: TALC, fragrance.
Osco
Brand Baby Powder. Contains: TALC, fragrance.
Jean
Nate Perfumed Talc. Contains: TALC, kaolin, magnesium
carbonate, fragrance.
Shower
to Shower. Contains: TALC, cornstarch, sodium bicarbonate,
fragrance, polysaccarides.
Ammens
Medicated Powder. Contains: Zinc oxide, cornstarch,
fragrance, isostearic acid, PPG-20, methyl glucose ether, TALC.
Cashmere
Bouquet Perfumed Powder. Contains: TALC, magnesium carbonate,
zinc stearate, fragrance.
Gold
Bond Medicated Powder. Contains: Menthol, zinc oxide,
boric acid, eucalyptol, methyl salicylate, salicylic acid, TALC,
thymol, zinc stearate.
FEMININE
PRODUCTS
Vagisil
Feminine Powder. Contains: Cornstarch, aloe, mineral
oil, magnesium stearate, silica, benzethonium chloride, fragrance.
Vaginex
Feminine Powder. Contains: Zinc oxide, cornstarch, fragrance,
6-hydroxquinoline, 8-hydroxquinoline sulfate, isostearic acid, PPG-20,
methyl glucose ether, TALC.
Summer's
Eve Feminine Powder. Contains: Cornstarch, tricalcium
phosphate, oxoxynol-9, benzethonium chloride, fragrance.
FDS
Feminine Deodorant Spray. Contains: Isobutane, isopropyl
myristate, cornstarch, mineral oil, fragrance, lanolin alcohol,
hydrated silica, magnesium stearate, benzyl alcohol.
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