Clinical Trials: Will the Wrong Trial Design Make Your Dietary Supplement or Functional Food an Unregistered Drug?

April 16, 2012 By

By Arwen Brooks
Quality Assurance & Regulatory Affairs Assistant

With the explosion of the natural health product and functional food industry, and the subsequent rules and regulations that have been put in place to ensure that consumers have access to safe and effective choices, the need for clinical trials that focus on demonstrating the advantages of various natural health product (NHP) ingredients has become essential to companies who focus on innovative products that may not have the benefit of being common knowledge.

Designing an effective clinical trial for a dietary supplement and functional food requires many considerations to ensure that the data produced is high-quality, reliable, and demonstrates the desired effect. Such considerations may include:

  • Knowledge of basic science
  • Pathophysiology
  • Good clinical practice (GCP)
  • Regulatory affairs

The major benefit for a company which has invested in a high-quality clinical trial would be increased sales and distribution, through the accreditation in peer-reviewed journals, marketing the use of the trial to demonstrate the superiority of their products, and the generation of unique health claims based on the results. The reverse also holds true with a poorly-designed or poorly-executed study: and the deficiencies can cause regulatory agencies to categorize the dietary supplement or functional food as an unregistered drug.

What is a Drug?

According to the FDA, a drug includes “articles intended for use in the diagnosis, cure, mitigation, treatment, and prevention of disease…” Therefore, if a clinical trial is performed in which a product is tested to diagnose, cure, mitigate, treat, or prevent a disease, FDA would classify the product as a drug. The draft guidance specifically exempts dietary supplement clinical trials from Investigational New Drug (IND) requirements: but only as long as the dietary supplement is being used to affect the structure and/or function of the body. Even with this exemption, the guidance does specify that “whether an IND is needed for a clinical investigation evaluating a dietary supplement is determined by the intent of the clinical investigation.” This means that, even if no drug claims are made on the supplement, the design of the trial may be the determining factor in the FDA’s classification.

The European Food Safety Authority (EFSA) also draws differences between study designs for supplements and drugs. Specifically, EFSA has stated that studies supporting non-drug products that target a non-drug market should be performed on a non-drug population. This means that the study group used for the clinical trial should be representative of the intended claim and target population.

There are many tools and techniques one can employ in order to design human clinical studies for non-diseased populations. The natural health products industry is therefore presented with an enormous opportunity by which it can firmly establish the efficacy and safety of its products, while responsibly staying within regulatory parameters. Please contact us if you need help in developing the appropriate clinical trial protocol for your product.