Nutrasource Blog

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 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: 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

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: Product Marketing, Pharmaceuticals, Regulatory, 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

The 5 Key Questions to Ask Before Your Next Product Launch

Posted by Nutrasource on Thu, Jun 25, 2015

You have an exciting new product idea and are ready to take the leap and go to market. Before you start selling, however, it is important to make sure your product is the best it can be from a regulatory standpoint.

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

An Introduction to Generally Recognized as Safe (GRAS) Filings for Food Ingredients

Posted by Dr. Robert McQuate, Ph.D., Chief Regulatory Officer - GRAS Associates on Thu, May 14, 2015

GRAS is an acronym for Generally Recognized as Safe.  GRAS status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act).  Its purpose was to exempt certain food ingredients from the definition of food additive.

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