The FDA Still Ignores the Lethal Risks of Talcum

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CHICAGO, IL - Up to 20 percent of U.S. pre-menopausal women regularly dust their genital area, sanitary pads or contraceptive diaphragms with cosmetic grade talcum powder. Manufactured by Johnson & Johnson, and widely distributed by Osco and Walgreens, besides other drug stores, women have been persuaded by advertisements to dust themselves to mask alleged genital odors. Not surprisingly, talcum powder has become a symbol of freshness and cleanliness for over five decades.

On November 17, 1994, the Chicago-based Cancer Prevention Coalition and the New York Center for Constitutional Rights submitted a Citizen Petition to the FDA, �Seeking Carcinogenic Labeling on all Cosmetic Talc Products.� The Petition was endorsed by Dr. Quentin Young, Chairman of The Health and Medicine Policy Research Group, by 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 this warning remains ignored.

Based on 15 publications in leading scientific journals dating back to the 1960�s, the Petition explicitly warned of �increased rates of ovarian cancer resulting from frequent exposure to cosmetic grade talc.� After over a year�s delay, the Petition was rejected by Dr. John Bailey, FDA�s past Director of the Office of Cosmetics and Colors, and currently Director of the industry�s The Personal Care Products Council. Since then, the strong relation between the genital use of talc powder and ovarian cancer has been endorsed by over 40 further scientific publications. These have reported increased risks ranging from 35% to 90%.

Of particular interest is a 1971 report on the identification of talc particles in ovarian cancers, a finding contested by Dr. G.Y. Hildick Smith, Johnson & Johnson�s medical Director. However, a subsequent publication in the prestigious The Lancet warned that �The potentially harmful effects of talc . . . in the ovary . . . should not be ignored.� This warning was further supported by a 2004 report on the major risk of ovarian cancer in talc users. However, there was no such risk in women whose fallopian tubes had been tied, blocking the access of talc dust to the ovaries.

Not surprisingly, the mortality of ovarian cancer for women over the age of 65, a relatively rare cancer at any age, has escalated dramatically over the last three decades, by 12% for white, and 32% for black women. It should further be noted that there are about 15,300 deaths from ovarian cancer each year. This makes it the fourth most common fatal cancer in women, after breast, colon and lung.

Nevertheless, the industry and, worse still the FDA, remain recklessly unresponsive to these dangers. The FDA has neither banned the genital use of talcum powder, nor required industry to label it with explicit warnings. This is all the more inexcusable since cosmetic grade starch powder is a readily available safe alternative.

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