Is my Neutraceutical Ready for Clinical Trial and Regulatory Submission?

Several neutraceutical clients recently asked me "When will their product be ready for clinical trials and subsequent regulatory submission? The need to know is twofold - one, FDA rigor and requirements, and two, to support marketing claims and increase perception and value of the neutraceutical in the eye of the FDA regulatory reviewer and the product consumer. Clinical trials generate data and documentation that must be collected and cleaned via SOPS for GLP, GMP, GCP and QC. The data must still be quality controlled and quality assured, consistent in statements, patient/subject outcomes and endpoints and marketing claims.

A clinical trial is considered "gold" in the dietary supplement industry yielding immediate marketing value. Other forms of data to support claims for a health ingredient or dietary supplement are not so compelling to the bottom line. Why? Consumers do want to know whether a neutraceutical, and there are many competing for the same claim, works on them and not just in animals, in theory and/or on the "bench". Companies, in the past, relied heavily in the absence of clinical trial data on consumer perception, testimonials and endorsements. However, that does not speak to the product's finished quality.

So, when is your neutraceutical ready for clinical trials?

Preclinical testing is next and prior to clinical testing and trials. The preclinical testing phase is similar to that of a regulated drug, device, biologic, vaccine, etc.
The preclinical testing includes:

• formulation development
• analytical development
• animal pharmacology
• animal toxicology.

Clinical trials are next in line. At this point, when the preclinical data is collected, QC, summarized and reviewed, and is "deemed" good - the neutraceutical is clinical trial "ready".

Preclinical and Clinical testing results become major factors when considering the acquisition of a neutraceutical product and thus must be quality assured with due diligence review.