Rockville, Md., June 26, 2007— The U.S. Pharmacopeia (USP) Dietary Supplements Information Expert Committee (DSI-EC) has voted to require cautionary statements on the labels for green tea extracts and black cohosh dietary supplements.
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.
As part of its mission to protect the public health, the USP DSI-EC reviews the safety profile for dietary ingredients and monitors adverse reports from diverse sources, including published case reports or reviews, safety data from clinical trials, pharmacokinetic studies, and animal studies. The committee also reviews reports from the European Medicines Agency, Health Canada’s Canadian Adverse Drug Reaction Monitoring Program, Australian Therapeutic Goods Administration, British Medicines and Healthcare Products Regulatory Agency, USP MEDMARX, and the U.S. Food and Drug Administration MedWatch program.
For more information, please send an email to [email protected].
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The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its four public health programs, visit www.usp.org/newscenter.