AHPA Suggests Another Tack to USP on Dietary Supplement Ingredient Safety Information

(January 29, 2008) — The American Herbal Products Association (AHPA) has suggested an alternative to an ingredient safety classification system adopted by the U.S. Pharmacopoeia (USP). That system, developed by the USP’s Dietary Supplement Information Expert Committee (DSI-EC), classifies ingredients into one of three categories that can be described as: Class 1 (safe with no labeling statement), Class 2 (safe only with a suitable labeling statement), or Class 3 (not safe irrespective of label statements).

AHPA recently submitted comments to USP, asking that they refrain from requiring cautionary statements on products containing USP-quality black cohosh (Actaea racemosa syn. Cimicifuga racemosa) articles or USP powdered decaffeinated green tea (Camilla sinensis) extract. Subsequent to this process AHPA recognized a greater concern regarding the presentation of safety information (required cautionary labeling) than dissemination in more appropriate ways. The present requirement for USP Class 2 ingredients applies only to dietary ingredients claiming USP quality, and limits the ability of manufacturers to appropriately advise consumers.

“USP should provide ingredient safety information that it believes is important to manufacturers,” said Steven Dentali, PhD, AHPA vice president for scientific and technical affairs. “However, USP’s proposed cautionary labeling statements are directed at consumers while ignoring manufacturers’ responsibility to produce safe products.”

The alternate suggested by AHPA would employ a safety information section in USP supplement ingredient monographs that presents the findings of the DSI-EC. AHPA believes that the information generated by this committee can serve the interest of public health by allowing manufactures to intelligently apply the findings of the DSI-EC as is appropriate on a product-byproduct basis.

Click here for AHPA’s letter to USP. (http://www.ahpa.org/portals/0/pdfs/08_0118_AHPAComments_USP.pdf)



The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.

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