HERBAL PRODUCT VOUCHER SPECIMENS FOR EACH PLANT BATCH RECOMMENDED

HERBAL PRODUCT VOUCHER SPECIMENS FOR EACH PLANT BATCH RECOMMENDED by pharmacologist Ryan Huxtable, PhD, University of Arizona, at an FDA staff seminar on July 28 as a way of assuring manufacturers' accountability. Huxtable said he "would like to see . . . that voucher specimens [of each batch of plants used] be maintained so that a botanist can go back if necessary and check to see exactly what was included" in a specific product. He characterized voucher specimens as samples of plants taken from each shipment used to manufacture herbal products and carefully preserved in a herbarium. Huxtable presented a "wish list" of regulatory "requirements" for herbal products that he suggested FDA should consider to ensure safety and efficacy. He recommended that FDA require that herbs be sold "in packaging that lists all botanical constituents in order of abundance with proper botanical names." Also, he proposed the establishment of an "adverse herb reaction or suspected adverse herb reaction" registry to track the chronic toxicity of herbs. "Perhaps one of the biggest problems in our society in deciphering herbal problems is the difficulty in showing the chronic toxic potential of plants," Huxtable observed. And, he pointed out, no "mechanism" exists "for collecting the data on which to draw conclusions about the chronic toxicity of a plant. There is no equivalent to the adverse drug reaction tracking system for manufactured drugs." He suggested that this has led to underreporting of adverse health effects from herbal preparations. Huxtable elaborated on his views of herbal supplement safety in testimony before the House Energy and Commerce/health subcommittee on July 29 (see preceding stories). Huxtable suggested that a "rational regulatory approach for herbs involves ensuring that the three goals of identity, quality, and substantiated therapeutic claims are met." Huxtable asserted that many of the plants included in herbal products on the market today are either misidentified or unknown. He noted that imported herbs have been found to contain synthetic steroids and drugs, such as diazepam. He also cautioned FDA to be aware of herbal products that may be adulterated or contaminated. He also advised that herb suppliers be required to "issue a certificate of authentication for each shipment of herbs." Regarding health claims, Huxtable insisted that all claimed benefits of herbs be "validated by approved clinical trials." Further suggestions made by Huxtable include spot-checking imported drugs for contamination and adulteration; and printing disclaimers of effectiveness on packaging for a product's ability to cause weight loss, retard aging, improve mental ability or memory, or improve sexual ability. For herbal products with demonstrated effectiveness for a given condition, Huxtable recommended that FDA set a minimum level of concentration for the active ingredient.