The Maryland-based American Herbal Products Association has submitted a formal request to the US Pharmacopoeia, the official American supplements industry quality standards setter and tester, asking it to abort plans for cautionary statements on products containing black cohosh (Actaea racemosa syn. Cimicifuga racemosa) or powdered decaffeinated green tea (Camilla sinensis) extract.
"AHPA believes that USP should not take on the regulatory duties of the US Food and Drug Administration and the Federal Trade Commission," said AHPA president, Michael McGuffin. "We also note that these USP proposals are inconsistent with their long-standing practice of not requiring similar cautions on drugs. If they do go forward with this practice, then it should be based on sufficient scientific evidence, for specific products at specific doses, duration and frequencies of use."
In its submission to USP, AHPA said of proposed black cohosh labelling requirements:
USP's proposed statements are:
Black cohosh 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.
For further information on AHPA's comments please contact Steven Dentali, PhD, AHPA's VP of Scientific and Technical Affairs. [email protected].