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This article was originally published in The Tan Sheet

Executive Summary

THURSDAY PLANTATION's TEA TREE TOOTHPASTE WILL BEGIN SHIPPING TO THE TRADE on Sept. 21. The company said it expects the product to reach store shelves by early October. The toothpaste, available in five ounce tubes, contains tea tree oil .4% as a "natural germicide" as well as the tooth polish calcium carbonate, the cleansing agent sodium lauryl sulfate, and chlorophyll as a breath freshener. Promotions for the toothpaste will include spots on radio shows, such as "Natural Grocer" out of Florida, "Here's to Your Health," which is syndicated to 115 stations, and a regional New York show, "In the Doctor's Office." Thursday Plantation also is planning to support the launch with magazine ads in Whole Foods Business; Natural Health; Body, Mind and Spirit and Delicious. Thursday Plantation said the toothpaste will be available from drug wholesalers McKesson and Bergen-Brunswig as well as through natural health food distributors Stow Mills, Cornucopia and Nature's Best. Among the major retailers that will carry the product, Thursday Plantation said, are Long's, Good Neighbor, Value Right, Mrs. Gooch's, Bread and Circus and Fresh Fields. In a consumer promotion planned for the Christmas season, Thursday Plantation will be offering its five ounce tube with a Radius toothbrush for $ 9.95 under a promotional arrangement with Kutztown, Penn.-based Radius Corporation. Radius has developed a toothbrush in left- and right-handed models with an "anatomical" handle and an oversized head designed to place bristles to the teeth at the "dentist-recommended" 45 degree angle. Founded in 1975, Australia-based Thursday Plantation, Ltd. said that U.S. sales topped $ 1.5 mil. in 1992 and projected that sales in this country will reach $ 5-$ 10 mil. by 1995. Worldwide sales in 1992 were about $ 6 mil. Privately held, the company is considering a public offering some time in the future. President Michael Dean and VP Suzanne Dean head the company's U.S. office in Montecito, Calif. The company markets a line of tea tree oil products including an antiseptic cream, shampoos, lozenges, Easit for nasal congestion and Fasit acne treatment gel. The company's pure tea tree oils are marketed as a facial cleanser, a vaginal cleanser, for scalp, sore gums, canker sores, cold sores, bad breath, insect bites and athlete's foot. Thursday Plantation also is an active member of the American Tea Tree Oil Association. Formed in 1991, the group's principal function is to coordinate the efforts of the various member companies in an attempt to include tea tree oil (oil of melaleuca) in the OTC antimicrobial monograph as a first aid antiseptic ingredient. The association, based in Muskegon, Mich., notified FDA in January 1992 of its intent to establish monograph status for tea tree oil based, in part, on data from Australia. In April 1993, Pittsburgh-based Mitech Labs submitted a petition to include tea tree oil in the monograph as a first aid antiseptic ("The Tan Sheet" May 3, p. 10). Mitech requested feedback from FDA on the petition in July ("The Tan Sheet" July 26, p. 24). The Tea Tree Oil Association recently completed minimum inhibitory concentration (MIC) testing, which is used to determine the smallest concentration of an antibiotic that regularly inhibits growth of a bacterial strain, the company noted. The association is preparing to submit these results to FDA. Thursday Plantation said the association tested concentrations of O%- 6% and 9% and the group indicated that it will recommend including tea tree oil in the monograph at a concentration of 2% or less. Although the association's initial focus is on establishing monograph status for the ingredient as an antiseptic, the group also is working on including tea tree oil in other OTC monographs. Eventually, the association will attempt to have tea tree oil included in the antifungal, dandruff, decongestant and acne monographs, Thursday Plantation said. In the meantime, FDA continues to monitor products with the ingredient. Idaho Falls-based Melaleuca Inc. received a warning letter from the agency on Aug. 24 covering the company's anti- acne product Zap-it. When launched in 1990, the product included both benzoyl peroxide and tea tree oil as active ingredients. The company has subsequently relabeled the product to list tea tree oil as an inactive ingredient. However, FDA said in the warning letter that based on the use of tea tree oil as an active ingredient "from the product's inception" and the company's "continued use" of promotional material touting tea tree oil, the agency regards the use of the ingredient "to be active irrespective of any label claim to the contrary."

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