The Gary Null Blog

"Botanicals"-products that contain ingredients of vegetable matter or its constituents as a finished product-may include whole plants, plant parts, or juices, gums, or oils, but not products such as Taxol(r), which, although originally isolated and purified from the Pacific yew tree (Taxus brevifolia), has been purified and standardized to homogeneity. In the U.S., use of botanicals to treat medical conditions is considered CAM. Botanicals are a unique class of products for regulators, because they may be classified as foods, drugs, biologics, or devices. Most drugs in the recent past in the U.S. have been homogenous substances. Most heterogeneous botanicals sold in the U.S. are classified as foods, including dietary supplements. This is in sharp contrast to foreign markets, where many botanicals are sold-and reimbursed-as drugs. Prompted by these regulatory issues, OAM, along with the NIH, FDA, and others, conducted five international meetings to examine evidence for and the role of botanical medicine in the U.S.