Thursday Plantation
This article was originally published in The Tan Sheet
Executive Summary
Company requests exemption from OTC labeling final rule for 15% Pure Tea Tree Oil Antiseptic (1/3 fl. oz.). "Label size is too small to fit bar lines and all the wording in the font size required," Australia-based firm states in Oct. 29 letter to FDA. Company's proposed labeling for "Drug Facts" panel excludes bar lines, box. Thursday Plantation still is awaiting agency decision on similar exemption request submitted in March for 2 oz. 100% Pure Tea Tree Oil; firm has submitted several versions of proposed labeling for that product (1"The Tan Sheet" April 30, In Brief)...
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Thursday Plantation labeling request
Proposed labeling for Thursday Plantation 100% Pure Tea Tree Oil contains unnecessary information in "Drug Facts" box, FDA advises in Jan. 25 letter. Statement about type of bottle used in packaging "is not required in the 'Other Information' section of the Drug Facts labeling and should be placed elsewhere," agency says. In addition, proposed labeling for 1/3 fl. oz. size uses type size smaller than required 6 point, which "is not acceptable." Thursday Plantation has submitted several labeling exemption requests for its tea tree oil products, asserting package size is too small to fit required bar lines, font size (1"The Tan Sheet" Nov. 26, 2001, In Brief)...
Thursday Plantation
Australia-based tea tree manufacturer requests exemption from OTC labeling final rule for 2 oz. 100% Pure Tea Tree Oil, saying compliance is "impracticable" because "label size is too small to fit bar lines and all the wording in the font size required." Moreover, "should the font size be decreased, the letters bleed slightly, which may cause deterioration of text legibility," company maintains in March 23 letter to FDA. Antiseptic is sold in health food stores worldwide under Thursday Plantation brand
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