Nutrasource Blog

The Supplement Industry Still Has a Claims Substantiation Problem. Here's How to Fix It

Posted by Douglas Kalman, Ph.D., R.D., CCRC, FACN, Vice President of Scientific Affairs on Wed, Jan 30, 2019

For the past decade, I've written and educated industry about the benefits of substantiating dietary supplement claims, from the rationale of complying with national regulatory rules to remaining ahead of the innovation curve.

But despite policing from the U.S.-FDA and FTC, and the negative media attention surrounding offending brands, the supplement industry still has a substantiation problem. There are far too many instances of companies under fire (or yet to be under fire) for unsubstantiated, misleading, or deceptive claims.

The good news is that this can be fixed with a clearer understanding of what qualifies as substantiation and how companies can benefit from making the investment in quality research. Read on to find out what you need to know.

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

GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?

Posted by Amy Mozingo, MS, Director of Operations - GRAS Associates on Thu, Jan 17, 2019

You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.

What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?

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

Regulatory Trends That Will Shape 2019

Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Thu, Dec 06, 2018

The past year was a whirlwind of regulatory change that brought exciting opportunities and new challenges in equal measure.

As we look to another game-changing year ahead, our regulatory and scientific team reviews the top regulatory trends expected to shape health product innovation and marketing in 2019 and beyond.

Here's what to expect...

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

How to Form a CRO Partnership That Delivers Results

Posted by Josh Baisley, B.Sc., Director of Clinical Trials 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., MBA, Marketing Director 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 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: 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 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