Recalls & Warnings
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Posted June 27, 2007
Warning Labels to be Required for Green Tea and Black Cohosh Products
The new labeling requirements came about after the USP DSI-EC reviewed numerous case reports suggesting a potential link between ingestion of products containing green tea extracts and black cohosh and liver damage. The original rating did not require cautionary statements.
“The cautionary statements are designed to alert the public and healthcare practitioners of potential adverse effects to reduce the risks associated with ingesting dietary supplements,” said Gabriel Giancaspro, Ph.D., USP Director of Dietary Supplements. “After reviewing the updated safety information collected for these ingredients, the committee determined that when these articles are used and formulated appropriately, the committee is unaware of significant safety issues, provided a warning statement is included in the labeling section.”
The cautionary statement required on dietary supplements with green tea extracts will read:
Caution: Must take with a meal. In rare cases extracts from green tea have been reported to adversely affect the liver. Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.
The cautionary statement required on dietary supplements with black cohosh will read:
Caution: In rare cases black cohosh has been reported to affect the liver. Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.
The USP DSI-EC is currently preparing case details, criteria of evaluation and discussion on the green tea extracts and black cohosh safety reviews to be published in peer-reviewed journals.
The cautionary statement for green tea extracts will appear in Pharmacopeial Forum for public comment as a revision to the initial USP proposal of the monograph “Powdered Decaffeinated Green Tea Extract.” The cautionary statement for black cohosh is scheduled to appear in September 2007 as a proposed Interim Revision Announcement in Pharmacopeial Forum 33 (5) for 60-day public comment.