Thursday Plantation
This article was originally published in The Tan Sheet
Executive Summary
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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Thursday Plantation
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)...
Thursday Plantation
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)...
Thursday Plantation
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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