The Secret to EFSA Health Claims: How Many Studies do you Really need?

Welcome to our 10-week EFSA Health Claims FAQ series, where we'll unravel the complexities of EFSA health claim applications and regulatory compliance. In this first installment, we'll tackle one of the top questions sponsors ask: "How many studies do I need for an EFSA health claim?“

Introduction

In this comprehensive guide, we'll take a deep dive into the science and regulations behind EFSA health claims, exploring why there's no one-size-fits-all answer and why it's crucial to demonstrate a consistent "cause and effect" relationship.

The Basics: Understanding EFSA Health Claims

Before we get into the specifics of how many studies you need, let's start with the basics. EFSA, the European Food Safety Authority, plays a pivotal role in evaluating health claims related to food products. Their primary objective is to ensure that claims are truthful, clear, and reliable, all while safeguarding consumer health.

EFSA categorizes health claims into various articles of legislation, but today, our focus is on Article 13.5 claims. These claims involve health benefits based on newly developed scientific data.

The Challenge of EFSA Health Claims

To set the stage, let’s look at the challenges associated with EFSA health claims. Over the years, there has been a perception of limited success, with EFSA approving less than one novel health claim annually over a significant period. The Transparency Regulation, introduced in 2021, didn’t do much to counter this perception. If anything, it strengthened it.

The Transparency Regulation aimed to enhance openness and transparency in food safety, but its implementation presented challenges for businesses seeking scientific reviews. This regulation introduced new e-platforms for notifying research studies and uploading of submissions, making the submission process more complex and time-consuming.

The Burning Question: How Many Studies do I need?

Now, let's get down to business and the reason you’re reading this blog post: "How many studies do I need for an EFSA health claim?" The short (but not so simple) answer is - it depends! There is no magical fixed number that will guarantee success. Why? Because success hinges on several factors, including the nature of your claim and your target audience.

What truly matters in EFSA health claim reviews is demonstrating a consistent "cause and effect" relationship. This is where quality human intervention studies come into play. These studies should be designed with an element of consistency in terms of outcomes and populations.

Why One Study Isn't Enough

Attempting to prove a solid "cause and effect" relationship with just one study, no matter how extensive, is like building a house with a single brick – it won't hold. EFSA insists on a robust body of evidence to substantiate health claims.

The Optimal Number: 3 - 5 Studies

So, what's the optimal number of studies? Consider aiming for three, four, or even five well-designed studies. These studies should not only meet high-quality standards but also exhibit consistency in their outcomes and the participants involved.

EFSA values quality and consistency above quantity. Shauni Fitzgerald, Regulatory Affairs & Research Manager at Atlantia noted that “It's not about overwhelming them with numerous studies; it's about providing a solid and consistent body of evidence that demonstrates the link between your product and the claimed health benefit”.

Case in Point: Recent Examples

Let's take a closer look at a recent EFSA health claim opinion. An aqueous extract from spinach, standardized for its thylakoid content that suppresses lipases to aid in weight reduction, is a prime example. This claim was backed by seven human studies and two animal studies, but not all of them made the cut, when scrutinized by EFSA’s scientists. Consistency and quality are key.

Similarly, an aqueous saffron extract claimed a beneficial effect on mood. It was supported by three human intervention studies and mode-of-action studies. However, one study involving patients clinically diagnosed with depression couldn't be extrapolated to the general population that is the target of these EU health claims, demonstrating the challenges of using patient studies in EFSA claims.

Conclusion: Quality, Consistency, and Credibility

In conclusion, navigating the world of EFSA health claims requires an understanding of the importance of quality and consistency in your studies. It’s not about quantity; it's about providing compelling and consistent evidence that links your product to the health benefit.

Remember that success in EFSA health claims isn't just about the number of studies; it's about the quality and credibility of the evidence you present. So, strive for three, four, or five well-designed, high-quality studies that consistently demonstrate the cause-and-effect relationship between your product and the health benefit.

Stay tuned for more valuable insights in our "Regulation Station" series! Should you need expert guidance on your EFSA health claim journey, don't hesitate to reach out. We're here to help you navigate with confidence.