November 17, 1994

CITIZEN PETITION SEEKING CARCINOGENIC LABELING ON ALL

COSMETIC TALC PRODUCTS

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 Coaliton, 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 ATalcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area inceases 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 wrning such as ATalcum 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 tha tmay 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:

      A...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)