(June 26, 2007) — The U.S. Pharmacopeia (USP) is proposing to require cautionary statements on the labels of dietary supplements that claim to contain USP-grade black cohosh (Actaea racemosa syn. Cimicifuga racemosa) or green tea (Camellia sinensis) extract. The proposed statements are:
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.
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.
Comments will be accepted for 60 days after publication of these proposals in USP’s Pharmacopeial Forum. The black cohosh proposal is to be published in September; no date was announced for publication of the green tea extract proposal.
The new labeling proposals came about after the USP Dietary Supplements Information Expert Committee (DSI-EC) reviewed case reports suggesting a potential link between ingestion of products containing green tea extracts and black cohosh and liver damage.
“It would be helpful if the safety reviews that led to the committee’s decisions were available to the public so that comments on the proposed cautionary statements could be better informed,” said Steven Dentali, PhD, AHPA’s VP of Scientific and Technical Affairs. Case details, criteria of evaluation and discussion on the green tea extracts and black cohosh safety reviews are to be published in peer-reviewed journals, according to USP.
The full text of USP’s announcement is online at: http://vocuspr.vocus.com/vocuspr30/Temp/Sites/2605/b81a7b3275a54d2899f0ecbe3aa93dd8/FY0725%20USP%20Issues%20Caution%20Statements.pdf.