US black cohosh and green tea label warnings unnecessary, says AHPA

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 has not considered the full range of products that may contain a variety of different forms of black cohosh or that the proposed caution is actually warranted for all dosages and use patterns.
  • That the need for a cautionary statement was based on an inappropriately narrow review of case reports, which without supportive data are insufficient to justify the proposed cautionary labelling.
  • Of green tea extract it said:
  • USP has disregarded the basic Paracelsian premise of toxicology, "The dosage makes it either a poison or a remedy." The proposed labelling would be required for instances where it is clearly not warranted (for example, preparations containing USP powdered decaffeinated green tea extract in dosage forms that closely approximate, and would perhaps be indistinguishable from, traditional green tea beverages).
  • USP has failed to describe needed additional research that would adequately address uncertainties, and has not identified criteria by which their codified cautionary statements would reasonably be removed.
  • 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.

    Green tea
    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].

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