Can Talcum Powder Cause Ovarian Cancer?

“A coalition of public health experts, medical doctors and consumers organizations is petitioning the U.S. Department of Health and Human Services and the Food and Drug Administration for labels on talcum powder products warning that frequent use is linked to ovarian cancer.

The petition addresses Secretary of Health and Human Services Mike Leavitt, and Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., a former director of the National Cancer Institute.

The group seeks labels with a warning such as, ‘Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer,’ on all cosmetic talcum products. The petition also seeks a public hearing at which evidence can be presented that the genital application of talc can result in its translocation to the ovary.

The Citizen Petition is submitted on behalf of: Samuel S. Epstein, M.D., Chairman, Cancer Prevention Coalition (CPC), and Professor emeritus Occupational and Environmental Medicine, University of Illinois at Chicago School of Public Health; Peter Orris, M.D., Professor and Chief of Service, University of Illinois at Chicago Medical Center; Quentin Young, M.D., Chairman, Health and Medicine Policy Research Group, Chicago; Rosalie Bertell, Ph.D., International Association for Humanitarian Medicine, Scientific Advisor to the International Institute of Concern for Public Health, Toronto, and the International Science Oversight Board of the Organic Consumers Association, Washington, D.C.; and Ronnie Cummins, National Director of the Organic Consumers Association.

This is not the first petition seeking such warning labels. On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Right submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”

The scientific basis of the 1994 Petition was admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.

_______________________________________________________________________________________

PETITION SEEKING A CANCER WARNING ON COSMETIC TALC PRODUCTS

May 13, 2008

Mike Leavitt
Secretary of Health and Human Services
U.S. Department of Health and Human Services

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs

Dockets Management Branch
Food and Drug Administration, Room 1601
5630 Fishers Lane
Rockville, MD 20852

This Petition, submitted 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, requests the Commissioner of Food and Drugs to require that all cosmetic talc products bear labels with a warning such as, “Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer.”

A. AGENCY ACTION REQUESTED

This Petition requests FDA to take the following action:
(1) Immediately require cosmetic talcum powder products to bear labels with a prominent warning such as: “Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.”

(2) Pursuant to 21 CFR 10.30 (h) (2), a hearing which will be held at which time we can present scientific evidence in support of this Petition.

B. STATEMENT OF GROUNDS
On November 17, 1994, the Cancer Prevention Coalition and the New York Center for Constitutional Rights submitted a Citizen Petition to the Commissioner of the FDA, “Seeking Carcinogenic Labeling on all Cosmetic Talc Products.”

The Petition was endorsed by Quentin Young, M.D., Chairman of The Health and Medicine Policy Research Group, Peter Orris, M.D., Director of Health Hazard Evaluation, Cook County Hospital, and Professor of Medicine, University of Illinois Medical School, Chicago, Nancy Nelson, Chair of the Ovarian Cancer Early Detection and Prevention Foundation, and subsequently by Senator Edward Kennedy. In a 1997 statement to the Senate, he requested the FDA to place a cancer warning on the label of talc products, besides other products containing known carcinogens. However, over a decade later his warning remains ignored.

The 1994 Petition was supported by 15 scientific publications. These included nine, from 1983 to 1992, on the major risks of ovarian cancer from the frequent application of brand or generic talc “baby powder” to the genital area of women without any warning of the risks involved. Two of these publications also reported that the genital application of talc could result in its translocation to the ovary.

The scientific basis of the 1994 Petition was further supported by J. Mande, Acting Associate Commissioner for Legislative Affairs of the Department of Health and Human Services. On August 25, 1993, he admitted that “We are aware that there have been reports in the medical literature between frequent direct female perineal talc dusting over a protracted period of years, and an incremental increase in the statistical odds of subsequent development of certain ovarian cancers … (However) at the present time, the FDA is not considering to ban, restrict or require a warning statement on the label of talc containing products.”

The scientific basis of the 1994 Petition was also admitted by the industry. In an August 12, 1982, article in the New York Times, Johnson & Johnson, the manufacturer and retailer of talc dusting powder, stated it was aware of a publication which concluded that frequent genital application of talc was responsible for a three-fold increased risk of ovarian cancer.

Warnings of these risks were emphasized by the Cancer Prevention Coalition in November 19, 1994, in letters to Mr. Ralph Larsen, CEO of Johnson & Johnson, and Mr. C.R. Walgreen, Chairman and CEO of Walgreens. Johnson & Johnson was urged to substitute cornstarch, a safe organic carbohydrate, for talcum powder products, and also to label its products with a warning on cancer risks.

In spite of the scientific evidence, and admission by Johnson & Johnson, the Petition was denied by Dr. John Bailey, FDA’s Director of the Office of Cosmetics and Colors, on the basis of the “limited availability” (of Agency resources) and on alleged scientific grounds. Dr. Bailey is currently Director of the industry’s Personal Care Products Council.

Evidence for the May 2008 Petition is supported by Edward Kavanaugh, President of the industry’s Cosmetic Toiletry and Fragrance Association. In 2002, he admitted that talc is “toxic,” that it “can reach the human ovaries,” and that prior epidemiological investigations concluded that its genital application increased the risk of ovarian cancer.

Further evidence for this Petition is based on 12 publications since 1995, cited below. These confirm the causal relation between genital application of talc and ovarian cancer, and the protective effect of tubal ligation or hysterectomy, preventing the translocation of talc to the ovary.

As Dr. Andrew C. von Eschenbach, former Director of the National Cancer Institute, is aware, the mortality of ovarian cancer for women over the age of 65, has escalated dramatically since 1975, by 13% for white and 47% for black women (1). There are about 15,300 deaths from ovarian cancer each year. This makes it the fourth most common fatal cancer in women after colon, breast and lung.

A case-control study, the largest to date, confirmed the relation between the perineal use of talc and ovarian cancer (2). This has also been confirmed by other reports (3-7). In view of the strength of this evidence, “formal public health warnings” were urged in 1999 (8).

An analysis of 16 pooled studies confirmed a statistically significant 33% increased risk of ovarian cancer associated with the perineal use of talc (9). A report by 19 scientists in eight nations worldwide, under the auspices of the International Agency for Research on Cancer, concluded that eight publications confirmed a 30-60% increased risk of ovarian cancer following the perineal application of talc (10). This risk has been confirmed in other reports (11, 12).

The protective effects of tubal ligation or hysterectomy, preventing the translocation of talc from the perineum to the ovary, have also been confirmed (2, 3, 4, 7).

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 his best knowledge and belief, 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:
Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
Professor emeritus Occupational and Environmental Medicine
University of Illinois School of Public Health, Chicago

REFERENCES
1. National Cancer Institute. SEER Cancer Statistics Review, 2005 (posted 2008).

2. Purdie D, et al. Reproductive and other factors and risk of epithelial ovarian cancer: an Australian case-control study. Survey of Women’s Health Study Group. Int J Cancer Sep 15;62(6):678-684, 1995.

3. Kasper CS & Chandler PJ Jr. Possible morbidity in women from talc on condoms [letter]. JAMA March 15;273(11):846-847, 1995.

4. Cramer DW & Xu H. Epidemiologic evidence for uterine growth factors in the pathogenesis of ovarian cancer. Ann Epidemiol July;5(4):310-314, 1995.

5. Chang S & Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer June 15; 79(12):2396-2401, 1997.

6. Daly M & Obrams GI. Epidemiology and risk assessment for ovarian cancer. Semin Oncol June 25(3):255-264, 1998.

7. Green A, et al. Tubal sterilisation, hysterectomy and decreased risk of ovarian cancer. Survey of Women’s Health Study Group. Int J Cancer June 11;71(6):948-951, 1997.

8. Cramer DW, et al. Genital talc exposure and risk of ovarian cancer. Int J Cancer May 5;81(3):351-356, 1999.

9. Huncharek M, et al. Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta-analysis of 11,933 subjects from sixteen observational studies. Anticancer Res Mar-Apr;23(2C):1955-1960, 2003.

10. Baan R, et al. Carcinogenicity of carbon black, titanium dioxide, and talc. The Lancet Oncology April vol 7:295-296, 2006.

11. Langseth H, et al. Perineal use of talc and risk of ovarian cancer. J Epidemiol Community Health April 62(4):358-360, 2008.

12. Merritt MA, et al. Talcum powder, chronic pelvic inflammation and NSAIDS in relation to risk of epithelial ovarian cancer. Int J Cancer 122:170-176, 2008.

CONTACT:
Samuel S. Epstein, M.D.
UIC School of Public Health
MC 922 – 2121 W. Taylor St.
Chicago, IL 60612
312-996-2297
epstein@uic.edu
Chairman Cancer Prevention Coalition
http://www.preventcancer.com”

[Quoted Source: Petition Seeks a Cancer Warning on Cosmetic Talc Products, World Wire Press Release dated May 15, 2008.]

Additional Resources (including contrarian views):

Comment: Until additional information is available about the safety of talc use, women who use talcum powder may wish to consider avoiding these products or substituting cornstarch-based powders that contain no talc. There is no evidence at present linking cornstarch powders with any form of cancer.

5 thoughts on “Can Talcum Powder Cause Ovarian Cancer?

  1. Check out this link. It also confirms that there is no causal relationship between talc use and ovarian cancer:
    http://www.ncbi.nlm.nih.gov/pubmed/18287871?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
    Eur J Cancer Prev. 2008 Apr;17(2):139-46.
    Perineal talc use and ovarian cancer: a critical review.
    Muscat JE, Huncharek MS.
    Department of Health Evaluation Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA. jmuscat@psu.edu
    Talc, like asbestos, is a silicate that has been studied in relation to cancer risk. Several studies conducted over the past 25 years found an association between perineal talc powders and ovarian cancer. The summary relative risk is about 1.3 (95% confidence intervals 1.2-1.5) and these data have been interpreted as supporting a causal role. In this review article, we discuss the chemical and morphological features of talc and asbestos, and explain why despite their similar chemical classification talc does not possess asbestos-like carcinogenic properties. The heterogeneity in the perineal dusting studies has raised important concerns over the validity of the exposure measurements, and the lack of a consistent dose-response effect limits making causal inferences. Perhaps more importantly, whereas it is unknown whether external talc dust enters the female reproductive tract, measures of internal talc exposure such as talc-dusted diaphragms and latex condoms show no relationship with ovarian cancer risk. In addition, the therapeutic use of high dose cosmetic grade talc for pleurodesis has not been shown to cause cancer in patients receiving these treatment modalities.
    Talc is not genotoxic. Mechanistic, pathology and animal model studies have not found evidence for a carcinogenic effect. In summary, these data collectively do not indicate that cosmetic talc causes ovarian cancer.

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    • Hi Axel,

      Thank you for your comments. As you know, it is important to report the facts relating to both sides of any story. The original posting presents the petition sent to the U.S. Department of Health and Human Services and the Food and Drug Administration, which requests labels on talcum powder products warning that frequent use is linked to ovarian cancer. At the end of the post, several medical studies are cited as a “contrarian view” to the position presented in the petition. In fact, one of your comments cites one of the medical studies cited in the original posting.

      In all fairness, I think it improper to call any of these arguments — pro or con — “tenuous at best” at this point in time. As you know, in December 2009, Deane Berg of Sioux Falls, South Dakota, filed a law suit against Johnson and Johnson and two mining companies for failing to warn consumers about the possibility of contracting ovarian cancer from talcum power. To my knowledge, that law suit is still pending. If the position in that law suit is “tenuous at best,” it will be dismissed on summary judgment, thereby disposing of the case. I think the concern is not so-called “pure talc,” rather, it is the possibility of talc contaminated with asbestos which can naturally happen in the ground prior to mining. It is my understanding that mining sites where talc is or may be contaminated with asbestos are not mined for consumer or cosmetic products. A rigorous scientific evidence-based evaluation should be performed to resolve the issue one way or another.

      Again, thank you for the comments. Best, Paul

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  2. While I understand your concerns, there are so many possible factors that might cause ovarian cancer so why single out talc? The link with talc use is tenuous at best! All J&J have done is admit that they are aware of a publication that makes such a claim linking talc and ovarian cancer. This doesn’t validate the claim or represent any admission of fault on their part!

    It seems a bit difficult to believe that the softest mineral known to man that is inert, insoluble in water or solvents and immune to acid or alkali attack is alleged to be toxic. If it is why is it used in chewing gum?

    The only reason preventing the FDA from taking any action against talc is the lack of clear evidence that talc is carcinogenic. That is why the American Conference of Governmental Industrial Hygienists (ACGIH) classifies talc (containing no asbestos fibers)in Group A4: Not classifiable as a human carcinogen. (Classes A1-A3 are for substances known to be carcinogenic to animals or humans).

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  3. my mom died of ovarian cancer 15 years ago, she used baby powder every day for more than 10 years.
    She came from a large family of woman and she was the only who had cancer. I truly believe that the cause of her ovarian cancer was due to the use of talc powder in the genital area.

    Like

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