Nutrasource Blog

A comprehensive clinical testing program is essential to the success of virtually all health products. Writing in the International Probiotics Association blog, Josh Baisley, associate director of clinical trials for Nutrasource, notes that ensuring the stability of a probiotic for the duration of clinical studies is a vital aspect of analyzing the outcome. 

When Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, which must be rigorously tested to prove both safety and efficacy before they are approved by the Food and Drug Administration (FDA) for commercial release, dietary supplements can go to market immediately. The FDA monitors the “claim” to ensure there is no implied cure wording and the Federal Trade Commission (FTC) assesses the truthfulness of the label claim only if there is a complaint.

As the probiotic segment continues to trend upward, more companies are investing in well-designed clinical trials to support efficacy.

One area that has presented substantial learning opportunities, and has helped shape the future of probiotic clinical trials, is the study of antibiotic associated diarrhea (AAD) and probiotic intake.

As the global voice of probiotics, the International Probiotics Association (IPA) has been working jointly with industry, government and academia to advance probiotic technology, research and product development.

Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.

Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.

Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.

Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:

Prebiotics and probiotics aren't going anywhere.  In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.

Study designs need to support the final claims including marketing claims.  Risk management is a key aspect of formulating a robust clinical development program and may include proof of concept studies such as dose ranging or multiple dose studies and pilot studies, prior to engaging in pivotal clinical studies to determine evidence of effect and variability around changes resulting from supplementation with the investigational product.

There are many questions that must be asked, and consecutive steps planned, in order to successfully develop and launch a dietary supplement.  These questions include:

Clinical research has become a fundamental step in the development of a dietary supplement. Nutraceutical companies are investing more in clinical research than ever before to support health and marketing claims and gain a competitive advantage in a saturated marketplace.