Thursday Plantation labeling request
This article was originally published in The Tan Sheet
Executive Summary
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)...
You may also be interested in...
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)...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.