Approximately 6 in 10 Americans report regularly using some type of dietary supplement, and approximately 1 in 6 Americans reports using herbal remedies on a regular basis. The diversity of manufacturers, manufacturing processes, and quality control issues are enormous. As with all plant products, herbal products are complex mixtures of a variety of chemical constituents with considerable variation in the growth, harvesting, and storage conditions, including different extraction procedures. Furthermore, not only is there variation in batches, but also the potential for contamination. In addition, herbal products have the potential to interact with pharmaceuticals. These problems have led to consumer and physician confusion about the use of herbal products and have not been satisfactorily resolved, because the Food and Drug Administration has only very recently started to fulfill its mission of consumer protection in the realm of dietary supplements. More importantly, we provide a working plan for addressing this important issue.