Nutrasource Blog

As the cannabidiol (CBD) market continues to gain steam, global regulators are working to carve out or update legal pathways to market. This makes keeping up—and staying compliant—an ongoing challenge for brands.

What if you could develop one dietary supplement, with a single product specification, and sell it in multiple countries simultaneously – with no reformulation or regulatory headaches involved?

Note: This article pertains to the United States. Products sold elsewhere are subject to different country/region-specific regulations.

Mandatory label compliance deadlines are drawing near. If you sell, or are planning on selling, a dietary supplement or food in the U.S., here is what you need to know about the updates required and how you can comply.

In addition to the changes to nutrition labeling, due for most companies January 1, 2020, FDA has set an official “uniform compliance date” of January 1, 2022 for final food and dietary supplement label regulations issued in 2019 and 2020. This compliance date also applies to the National Bioengineered Food Disclosure Standard.

With so many label updates coming in the near future, will your brand ready?

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.

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 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.

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.

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.