Neutraceutical Clinical Trials and Regulatory Submission

Today, neutraceutical companies are increasingly dedicated to clinical trials and quality-controlled data and outcome endpoints; however, two types of preclinical research - "Formulation & Analytical Development" and "Animal Pharmacology & Toxicology" - are important, although the investment can seem costlier than the results.

Lets discuss F&AD first:

Most companies find a novel compound from countries, India, China, Japan, Poland, Russia, for examples, that they want to market as a neutraceutical globally. The neutraceutical company performs some relevant inhouse laboratory testing and obtain data to substantiate certain health and pharma benefits. The question: Is your neutraceutical ready to make that same claim in most countries? The answer: No.

To be able to market and make the claim worldwide, the finished product must have quality and consistency, and achieve FDA regulatory GMP CMC-like standards. Ingredient certificates of analysis (CoA) provide details on the ingredient itself; however, formulation and production steps ranging from granulation to tablet formation can impact the compound. Further, novel delivery systems and dosage forms also affect an ingredient's bioavailability and stability.

On a global level, innovation in novel neutraceutical dosage forms has been slow, although some actives have been converted into forms suitable for the food and beverage formulation (and FDA).

The net-net - if a finished product is not standardized as it leaves the production lines, demonstrating shelf stability, product consistency, batch to batch, lot to lot, safety and efficacy - your product will not be well accepted by the consumer, the market, the FDA and will not be allowed import/export from country to country.

Quality control of testing claims - data, process and documentation is a must.