Nutrasource Blog

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.

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?

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...

The advent of new DNA sequencing technologies has fundamentally changed how we use DNA data to solve real-world problems. The first of those changes was in the technology that acquires DNA sequence data. The second was in the analysis of that data. (For more, see my previous post, Can DNA Solve the Supplement Industry's Identity Problems?)

One of the branches of DNA data analysis is what we now call metagenomics – a term frequently used but not always understood.

Here I explain what this technique is and how nutraceutical and food industries can use it to verify the identity of products, such as probiotics and prepared foods in mixtures, with more certainty than ever.

At this year's SupplySide West, we had the pleasure of presenting on a topic that consistently poses challenges for the health and sports nutrition market: how to reach the sizable, but largely untapped, segment of "fit" customers looking to build lean muscle mass.

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.

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!

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

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.

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.