"…Not Intended to Diagnose, Treat, Cure or Prevent Any Disease." 25 Years of Botanical Dietary Supplement Research and the Lessons Learned.

Botanical dietary supplements (BDS) are complex mixtures of phytochemicals exhibiting complex pharmacology and posing complex research challenges. For 25 years, clinical pharmacologists researching BDS have confronted a litany of issues unlike those encountered with conventional medications. Foundational to these concerns is the Dietary Supplement Health and Education Act of 1994, which exempted BDS from premarket safety and efficacy trials. In the ensuing period, safety concerns regarding multi-ingredient products formulated as "proprietary blends" and herb-drug interactions have garnered significant attention. Idiosyncrasies unique to BDS can affect the outcome and interpretation of in vitro and in vivo studies, and although "omics" approaches hold promise in uncovering BDS efficacy mechanisms, purposeful adulteration threatens their safety. Despite a quarter century of public use, healthcare professionals still know little about BDS, thus it falls to industry, government, and academia to join forces in promoting a new paradigm for BDS research and product development.