FDA acknowledges Country Doctor HerbalsInc.’s steps towards compliance with dietary supplement good manufacturing regulations, but the Cheyenne, Wyo., firm’s response to problems noted in an agency inspection fails to provide sufficient detail. The Office of Regulatory Affairs Denver District in a June 10 warning letter
said Country Doctor also makes drug claims for its products, some of which are mis-branded due to the omission of required information. Violative claims include “all natural herbal formula that works to rid the body of flu” for Herbal Flu Be-Gone; “… works to rid the body of parasite infestation” for Herbal Parasite Cleanse; and “… works to relieve various aches and pains” for Herbal Pain-A-Way,” according to the letter. The GMP violations FDA listed include failing to establish written procedures for the responsibilities of quality control operations, to establish finished product specifications for identity, purity, strength, and composition for finished batches of supplements and to collect reserve samples of each lot of packaged and labeled supplements