Botanical drugs are botanical products that intend to diagnose, cure, mitigate, treat, or prevent disease in humans, under section 505 of the FD&C Act.  This applies to both research and commercial products.  If you are a researcher who aims to clinically investigate the efficacy potential of a botanical product in the treatment or prevention of disease, you are no longer classified as a dietary supplement and you will need to submit an Investigational New Drug (IND) application.  Please click here for more information regarding the regulation of clinical trials on herbal products.

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The regulations of botanical drugs are synonymous with pharmaceutical drugs with variances to accommodate the complex, poly-molecular structure of botanical drug products.  The most challenging and complex component of a botanical drug regulatory submission is the Chemistry, Manufacturing, and Controls (CMC).  It is estimated that 75% of botanical drug IND’s are put on clinical hold because of deficiencies in CMC data.   BRC has the expertise to support the development of your CMC for a botanical drug product, with their  background in analytical chemistry as well as regulatory affairs.