Nutrasource Blog

How to Form a CRO Partnership That Delivers Results

Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery 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, Regulatory, Concept to Claim

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

Substantiating Products With No Guidance: The CBD Confusion

Posted by Susan J. Hewlings, Ph.D., R.D., 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: Claims, Regulatory, Cannabis

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: Regulatory, Dietary Supplements/Natural Health Products

Next Steps for Commercializing Medical Cannabis Products in Canada, the U.S., and Beyond

Posted by Nutrasource on Tue, Jul 17, 2018

Canada has made history as the second country to legalize cannabis nationwide. The world is watching to see how the landscape for cannabis and related products will change as the Cannabis Act and associated Cannabis Regulations and Industrial Hemp Regulations come into force on October 17, 2018.

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Tags: Cannabis

Reverse-Engineering Your Regulatory Strategy for More Efficient Product Development

Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery 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 Nutrasource on Wed, Jun 27, 2018

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

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

Can DNA Testing Solve the Supplement Industry’s Identity Problems?

Posted by David Erickson, Ph.D. on Thu, Jun 21, 2018

It’s surprisingly easy not to notice that you are living in a time of revolution. The technological revolution we are living through has been rumbling along for so long now, sometimes it’s hard to appreciate it or get excited. But the revolution in DNA sequencing and its effects on society are worth our attention – especially when it comes to how we characterize and identify natural products.

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

What to Expect When Conducting Dietary Supplement Clinical Trials

Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery on Tue, Mar 20, 2018

One of the most common questions we hear from clients early in the product lifecycle is: "How do I let my customers know our product is safe, and that it works?"

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Tags: Clinical Trials

Nutrasource, GOED, DSM Jointly Publish Largest-Ever Fish Oil Oxidation Study

Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Fri, Feb 23, 2018

Fish oil supplements remain popular sources of EPA and DHA omega-3 fatty acids. Some studies have suggested that commercially available fish oil supplements are excessively oxidized, impacting oil quality and safety.

To investigate this issue, Nutrasource's scientific team paired with the Global Organization for EPA and DHA Omega-3s (GOED) and DSM to commission the largest study ever to evaluate oxidation parameters in a large database of fish oil omega-3 dietary supplements, and to compare the data with other common commercially available dietary oils.

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Tags: Product Testing & Certifications, Omega-3s, Dietary Supplements/Natural Health Products