May 1998

FDA has been notified of a case of neonatal tetanus associated with the use of a cosmetic facial clay as a dressing on an umbilical cord stump. The product "Indian Healing Clay" is marketed by Aztec Beauty Products as a facial mask. However, other uses of this product have been publicized, including the use of this product as a healing salve by midwives, as discussed on an Internet site on "cordcare." This site also discussed the uses of this product as a dressing on insect bites, splinters, cuts, scrapes, rashes, and as a drawing agent for cysts and boils. Interestingly, the website does question the sterility of this product for these uses, and specifically mentions tetanus.

Although this particular case occurred in an infant of a mother who did not have adequate protection against tetanus (the mother was apparently not vaccinated), others (infants, the elderly or immunocompromised) may be at risk because of poor protective antibody titers against tetanus. Infection with other microorganisms present in soil is also possible. Prudent health practices dictate that care be exercised in the use of any topical agent which is applied to a wound or otherwise abnormal skin surface because of the potential for contamination, infection or systemic absorption. This advice is particularly relevant to those with a weakened immune system who are at increased risk for such infections.

For further information, contact John E. Bailey, Ph.D., Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, at (202) 205-4530.

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