Nutrasource Blog

How to Form a CRO Partnership That Delivers Results

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Mon, Oct 15, 2018

The term "partnership" has become a trendy word in the contract research organization (CRO) world. While it's meant to describe a close collaborative relationship between CRO and client, too many organizations claim to be partners when in reality they are only research sites or project-based consultants.

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Tags: Clinical Trials, Concept to Claim, Regulatory

How to Not Get Kicked Off Amazon.ca for Non-Compliant Natural Health Products

Posted by Jennifer Andrews, M.Sc. on Mon, Sep 24, 2018

If you're already selling your supplement on Amazon in the U.S. or elsewhere around the globe, Canada is a natural next step to achieve growth and gain market share.

But if you're looking to enter the Canadian market for the first time via Amazon.ca, be warned - it's not as simple as setting up an account and listing your products!

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Tags: Dietary Supplements/Natural Health Products, Regulatory, Product Marketing

Prop 65 Updates: How to Ensure Dietary Supplement Compliance in California

Posted by Kevin Yan, M.Sc., Director of Analytics & Certifications on Fri, Sep 07, 2018

In the wake of California's updated Prop 65 requirementswhich came into force August 30, 2018—many of our clients have approached us with questions regarding compliance.

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

Substantiating Products With No Guidance: The CBD Confusion

Posted by Dr. Susan J. Hewlings, Ph.D., RD, Director of Scientific Affairs on Fri, Aug 17, 2018

While many U.S. states (and, of course, Canada) are approving medical and recreational use of cannabis products, confusion about how these products are regulated continues to grow.

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Tags: Cannabis, Claims, Regulatory

Implications of FDA's GRAS and NDIN Policy Changes for Supplements and Medical Foods

Posted by Dr. Richard Kraska, Ph.D., Chief Scientific Officer - GRAS Associates on Tue, Jul 24, 2018

Our regulatory affairs team has regular contact with the U.S. Food and Drug Administration (FDA) for a number of projects. Occasionally we learn about subtle policy shifts regarding Generally Recognized as Safe (GRAS) Notifications and New Dietary Ingredient Notifications (NDIN).

Below is an overview of FDA’s latest updates to GRAS and NDINs which will have important implications for the dietary supplement and medical foods industry in the U.S.

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Tags: Dietary Supplements/Natural Health Products, Regulatory

Reverse-Engineering Your Regulatory Strategy for More Efficient Product Development

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Thu, Jul 12, 2018

Regulatory strategy is the backbone of successful product development. Brands that lack a clear regulatory plan at the beginning of the process can face longer times to market and potentially higher costs associated with re-work or failure.

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

How Health Canada’s Upcoming Self-Care Product Regulations Could Impact Your Marketed Natural Health Products, Non-Prescription Drugs, and Cosmetics

Posted by Frederick Choy, B.Sc., Regulatory Affairs Specialist on Wed, Jun 27, 2018

New self-care product regulations are coming to Canada. Will your brand be ready?

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Tags: Regulatory, Product Marketing, Pharmaceuticals, 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, Dietary Supplements/Natural Health Products, Foods & Beverages