Medicinal botanicals used in cosmeceuticals are considered food additives or dietary supplements by the United States Food and Drug Administration (FDA) which declared them as safe. The herbs are allowed to be marketed to consumers directly without obtaining drug status or restricted by FDA’s over-the-counter monograph requirements. Thus, no standards of herbal potency, concentration in the marketed product, safety, nor efficacy studies exist.
The German Regulatory Authority for herbs is the “Commission E.” It is the best expert consensus for weighing the quality of clinical evidence and systemic and topical safety to identify reasonably effective uses of over 300 botanicals (3).
The Physician’s Desk Reference for Herbal Medicines, 3rd ed. (2004), by Thomson PDR, Montvale, NJ, published an exhaustive literature review conducted by the respected PhytoPharm U. S. Institute of Phytopharmaceuticals for about 400 more herbs with regard to their use and adverse reactions (3).