Petition Seeking a Cancer Warning on Cosmetic Talc Powder Products

CHICAGO, May. 19 /PRNewswire/ --

CHICAGO, May 19 /PRNewswire-USNewswire/ -- On May 13, 2008, the Cancer Prevention Coalition, endorsed by leading national authorities, submitted this Petition to the FDA. This updates scientific information detailed in a November 17, 1994, Citizen Petition which was denied by the FDA. It also documents prior knowledge of the FDA and industry on the cancer risks of cosmetic talc.

The scientific basis of the 2008 Petition is detailed in 11 reports in leading national and international scientific journals. These document the increased risks of ovarian cancer, ranging from 30% to 60%, from genital dusting with talc powder. In view of the strength of this evidence, a 1999 publication by a leading national expert urged that "formal public health warnings" should be made against the genital use of talcum dusting powder. Of further relevance is well-documented scientific evidence that ligation of the fallopian tubes or hysterectomy is protective against the dangers of talc by preventing its access to the ovaries.

It should further be emphasized that cornstarch, an organic carbohydrate, powder is a safe and effective alternative to talcum powder products.

As the Petition states, FDA Commissioner Dr. Andrew C. von Eschenbach, former Director of the National Cancer Institute, is or should be aware, that 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. There are now about 15,300 deaths from ovarian cancer each year. This makes it the fourth commonest fatal cancer in women after colon, breast and lung. Yet Dr. von Eschenbach has failed to mandate a cancer warning label on talc powder, let alone ban its continued use.

Information on the cancer risks of talc dusting powder is not new to the FDA, nor to the industry.

As stated in the Petition, J. Mande, Acting Associate Commissioner for Legislative Affairs of the Department of Health and Human Services, admitted in August 1993 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."

More reckless is the admission, in an August 12, 1992 New York Times article by Johnson & Johnson, the manufacturer and retailer of talc dusting powder, that frequent genital dusting with talc increases risks of ovarian cancer by three-fold. This risk was belatedly admitted this year by the industry's Cosmetic Toiletry and Fragrance Association.

Finally, Senator Edward Kennedy, in a 1997 statement to the Senate, requested the FDA to place a cancer warning on the label of talc products, besides other products containing known carcinogens. Nevertheless, over a decade later this warning remains ignored.

Samuel S. Epstein, M.D.

Chairman, Cancer Prevention Coalition

Professor emeritus Environmental & Occupational Medicine

University of Illinois at Chicago School of Public Health

Chicago, Illinois

Past President, Rachel Carson Council, Inc.

epstein@uic.edu

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312.996.2297

Endorsed by: Quentin Young, M.D., Chairman, Health and Medicine Policy Research Group, Chicago, Past President, American Public Health Association; Peter Orris, M.D., Professor and Chief of Service, University of Illinois at Chicago Medical Center; Rosalie Bertell, PhD, International Association for Humanitarian Medicine; and Ronnie Cummins, National Director of the Organic Consumers Association.