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Tea tree oil inclusion in OTC antiseptic monograph may require additional studies -- FDA.

This article was originally published in The Rose Sheet

Executive Summary

TEA TREE OIL INCLUSION IN OTC ANTISEPTIC MONOGRAPH will probably require additional clinical studies, FDA staff indicated at a July 24 "OTC feedback" meeting with representatives of Thursday Plantation and the American Tea Tree Association. An increasingly popular ingredient in the cosmetic industry, tea tree oil has recently appeared in several face and body care lines. In June, The Body Shop launched its 12-SKU tea tree oil skin, body and hair care line, which includes a three-step facial regimen, a blemish stick and a shampoo for "itchy scalp" ("The Rose Sheet" May 1, p. 4).
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