Nutrasource Blog

IGEN™ Certification: Flexibility for Suppliers, Transparency for Consumers

Posted by Nutrasource on Thu, Apr 13, 2017

Consumers have become increasingly concerned about the use of genetically modified organisms (GMOs) in food production — an occurrence that has contributed to the popularity of products that have not been genetically engineered (GE) through modern biotechnology. 

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Tags: Dietary Supplements/Natural Health Products

Managing Risk in Probiotic Stability

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Tue, Apr 11, 2017

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. 

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Tags: Clinical Trials, Probiotics

Setting Higher Quality Standards for Label Claims

Posted by Rodney Butt, M.Sc., MBA on Wed, Feb 15, 2017

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.

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Tags: Product Testing & Certifications, Product Marketing, Claims, Dietary Supplements/Natural Health Products

Demystifying Clinical Study Designs for Probiotics

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Wed, Oct 12, 2016

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.

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Tags: Clinical Trials, Probiotics, Dietary Supplements/Natural Health Products

The Future of Probiotics is Bright: Q&A with International Probiotics Association's George Paraskevakos

Posted by Jennifer Andrews, M.Sc. on Tue, Sep 13, 2016

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.

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Tags: Events, Probiotics, Dietary Supplements/Natural Health Products

What to Look for in a Dietary Supplement CRO

Posted by Nutrasource on Wed, Aug 31, 2016

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

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Tags: Clinical Trials, Regulatory, Dietary Supplements/Natural Health Products

5 Essential Tips for Substantiating Dietary Supplement Claims

Posted by Jennifer Andrews, M.Sc. on Mon, Jun 13, 2016

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:

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Tags: Product Marketing, Clinical Trials, Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

Taking an Integrated Clinical and Regulatory Approach for the Prebiotic/Probiotic Market

Posted by Jennifer Andrews, M.Sc. on Wed, Jan 27, 2016

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.

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Tags: Clinical Trials, Pharmaceuticals, Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products

Understanding the Differences Between Phase I, II, III, and IV Clinical Trials

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Thu, Dec 03, 2015

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.

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Tags: Clinical Trials, Dietary Supplements/Natural Health Products

Start with the Product Claim When Developing a Dietary Supplement

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Thu, Nov 12, 2015

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:

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Tags: Claims, Concept to Claim, Dietary Supplements/Natural Health Products