AHPA urges changes to cautionary labeling
U.S. Pharmacopoeia (USP) asking to stop the requirement cautionary
statements for quality black cohosh and powdered decaffeinated
green tea extract.
"USP should provide ingredient safety information that it believes is important to manufacturers," said Steven Dentali, 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." Developed by the USP's Dietary Supplement Information Expert Committee (DSI-EC), the current system classifies ingredients into one of three categories: 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). In a letter to USP, dated January 18, 2008, AHPA asked USP to 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. According to present requirements, USP Class 2 ingredients apply only to dietary ingredients claiming USP quality, which therefore limits the ability of manufacturers to appropriately advise consumers, said AHPA. "AHPA believes that better mechanisms exist to disseminate information regarding the safety concerns of dietary supplement ingredients and questions why the DSI-EC chose labeling as the only criteria for communicating the difference between safety classifications," states the letter to USP. "Labeling is not an adequate distillation of the scope and depth of information reviewed, conclusions reached or their degree of uncertainty. Herbal ingredient safety must be understood in context of other factors that affect product safety. Therefore, the implementation of a one-size-fits-all labeling requirement can never be right or adequate." AHPA suggested an alternative, based on 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. Independent support Commenting independently on AHPA's concerns, Mark Blumenthal, founder and executive directos of the American Botanical Council (ABC) told NutraIngredients-USA.com: "In principle, ABC believes that some of USP's methods for evaluation of the relative safety of botanical ingredients and finished products may be inadequate." Bumenthal continued: "At the end of Oct ABC published its comments to USP regarding its proposed caution on black cohosh products. "At that time, we raised the issue that the USP's DSI-EC - although it did include numerous persons with expertise in pharmacognosy, clinical medicine and other related fields - it did not include a medical toxicologist, nor an epidemiologist, nor possibly other disciplines which ABC deems necessary for the rational and appropriate evaluation of the relative safety of any botanical ingredient and/or finished product. "ABC was also concerned that USP released the news of its proposed cautions for black cohosh and green tea extract for public comment to the general public in such a way as to possibly generate confusion and/or misinformation among consumers, since the news of the proposed cautions was carried by various consumer publications. "In other words, prior to the DSI-EC's having the benefit of expert feedback in the public comment period, which, may have had the effect of modifying either of the proposed cautions, and/or rendering them null, i.e., depending on such public comment and the EC's response to such." Blumenthal noted that ABC started in 2002 its Safety Assessment Program to develop peer-reviewed safety reviews on about 24 popular herbs in the North American marketplace "In producing the Safety Assessment Program, ABC understood that in addition to label guidance, a broader, more general educational effort is necessary, i.e., educational materials that are geared towards manufacturers and health professionals, in addition to consumers," he said. "AHPA has raised numerous concerns in its letter of January 18, and, upon careful examination, Mr. McGuffin and Dr. Dentali's concerns appear to have merit and their suggestions seem reasonable," Blumenthal told this website. "The proposal to create a new section of safety information in USP monographs for those materials for which enhanced safety data may be warranted merits the USP's consideration," he concluded.
