(January 11, 2008) — The American Herbal Products Association (AHPA) has submitted two sets of comments to the U.S. Pharmacopeia (USP), asking that they refrain from requiring cautionary statements on products containing USP black cohosh (Actaea racemosa syn. Cimicifuga racemosa) or USP powdered decaffeinated green tea (Camilla sinensis) extract. USP’s 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.

“AHPA believes that USP should not take on the regulatory duties of the U.S. Food and Drug Administration and the Federal Trade Commission. We also note that these USP proposals are inconsistent with their long-standing practice of not requiring similar cautions on drugs,” said Michael McGuffin, AHPA’s president. “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.”

Among its comments to USP regarding the black cohosh caution, AHPA notes:

• 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 labeling.

AHPA’s comments on proposed green tea extract labeling include:

• USP has disregarded the basic Paracelsian premise of toxicology, “The dosage makes it either a poison or a remedy.” The proposed labeling 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.

For further information on AHPA’s comments please contact Steven Dentali, PhD, AHPA’s V.P. of Scientific and Technical Affairs.