Monteloeder's RelaxPLX® Unlocks Global Markets with Dual Regulatory Wins

MADRID, Spain – June 24, 2026 – In a significant strategic move, Monteloeder, SL, a subsidiary of SUANNUTRA SA, has secured pivotal regulatory approvals for its RelaxPLX® ingredient in two of the world's most demanding supplement markets. The lemon verbena formulation has received an individual license from South Korea's highly rigorous Ministry of Food and Drug Safety (MFDS) for sleep quality support, alongside a comprehensive Product License from Health Canada covering a range of sleep and stress-related claims.

These dual achievements represent more than just a procedural victory; they are a critical validation of the ingredient's scientific backing and a strategic key unlocking major growth opportunities across North America and Asia Pacific.

"Attaining these health claims is an important regulatory milestone for RelaxPLX in North America and Asia Pacific," said Stephanie Guillén-Díaz, Chief Commercial Officer for SUANNUTRA. "This strengthens the ingredient's credibility and provides a valuable platform for business development with Canadian, South Korean and international partners."

Navigating the Global Regulatory Gauntlet

For companies in the nutraceutical space, market access is often dictated by the ability to navigate complex and varied international regulatory frameworks. The approvals from Canada and South Korea are particularly noteworthy because both countries operate stringent pre-market approval systems, standing in contrast to jurisdictions that rely more heavily on post-market surveillance.

Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) requires all-natural health products to obtain a product license, complete with a Natural Product Number (NPN), before they can be sold. This process involves a thorough review of evidence supporting the product's safety, efficacy, and quality. For RelaxPLX®, this resulted in a license that substantiates multiple specific benefits, providing a clear and authorized framework for brands to communicate with Canadian consumers.

The hurdle in South Korea is arguably even higher. The country's Health Functional Foods Act is governed by a "positive-list" system, and gaining entry for a new ingredient requires an "Individually Recognized Functional Ingredient (IRFI)" approval from the MFDS. This demanding, multi-stage process required Monteloeder to submit a detailed dossier covering everything from the botanical source and extraction process to quality specifications, safety data, and robust clinical substantiation. The objective was to prove that a 400mg daily intake of RelaxPLX®'s lemon verbena extract could demonstrably improve sleep quality.

The successful navigation of this regulatory maze, accomplished in collaboration with local expert partner COSMAX BIO, signals a deep commitment to scientific rigor and provides a powerful competitive advantage.

The Science of Serenity: Beyond Basic Sleep Aids

In a crowded wellness market saturated with generic sleep aids, RelaxPLX® distinguishes itself by addressing the interconnected nature of sleep and stress. The claims approved by Health Canada reflect this holistic approach, going beyond a simple sleep quality claim to include:

• Temporarily relieves symptoms of perceived stress.
• Helps reduce cortisol, a biomarker of physical stress.
• Helps improve sleep quality in adolescents with stress.
• Helps improve sleep quality in individuals with symptoms of mild anxiety.

"These claims differentiate RelaxPLX positioning because they combine two highly relevant consumer concerns: sleep quality and stress-related wellbeing," explained Guillén-Díaz. "This is exactly what brands are looking for."

This positioning is not just marketing; it's rooted in robust clinical evidence. The ingredient is supported by three dedicated randomized, placebo-controlled clinical studies conducted on diverse populations, including adults with stress and adolescents. This scientific foundation was critical for securing the high-bar regulatory approvals.

"These studies provide strong backing for RelaxPLX's® efficacy, showing that its clinical story is not based only on subjective consumer perception," noted Daniel González-Hedström, PhD, R&D Director for SUANNUTRA. He emphasized that the research combined validated questionnaires with "objective sleep assessment, and physiological markers" to demonstrate benefits consumers can clearly understand, such as better sleep, stress balance, and feeling more restored.

A Strategic Play for the Booming Wellness Market

These regulatory milestones are a cornerstone of SUANNUTRA's broader strategy for global expansion. The sleep aid and stress management supplement markets are experiencing explosive growth, driven by a global population grappling with the pressures of modern life. By securing entry into the highly respected Canadian and South Korean markets, Monteloeder has established a powerful foothold in both North America and the influential Asia-Pacific region.

"The individual license permits Korean brands using RelaxPLX to label their products with a sleep quality support claim," explained Mariana Ortega, Science Marketing Manager for SUANNUTRA. "This achievement represents a significant step forward for SUANNUTRA, not only in the South Korean market but also in many countries in Asia Pacific."

The strategy extends beyond mere ingredient sales. The company has developed the "Visible Health Platform," a framework designed to translate complex clinical science into tangible benefits that resonate with end-users. RelaxPLX® is a key component of the platform's "Visible Balance" category, which focuses on benefits people can experience in their daily rhythm. This strategic framing helps partner brands create products that are not only scientifically validated but also emotionally compelling and practically relevant to consumers' lives. It transforms a scientifically proven ingredient into a solution for waking up more restored, feeling more balanced, and better managing the challenges of everyday life. This makes RelaxPLX® a highly attractive proposition for brands aiming to develop the next generation of wellness products.