The health claims will help drive collaboration with leading international supplement brands Monteloeder, SL, a subsidiary of SUANNUTRA SA, announces RelaxPLX has officially received individual license approval for its sleep…

The health claims will help drive collaboration with leading international supplement brands

Monteloeder, SL, a subsidiary of SUANNUTRA SA, announces RelaxPLX has officially received individual license approval for its sleep quality support by the Ministry of Food and Drug Safety (MFDS) of South Korea. In addition, this lemon verbena formulation attained a Health Canada Product License for multiple sleep and stress claims.

“Attaining these health claims is an important regulatory milestone for RelaxPLX in North America and Asia Pacific,” exclaims 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.”

Health Canada claims

The Health Canada Product License gives RelaxPLX an authorised claim framework in one of the world’s most established and respected supplement markets. The approved Canadian claims are closely aligned with RelaxPLX’s core clinical evidence and commercial positioning:

Helps improve sleep quality.

Helps improve symptoms of sleep disturbance and thereby promotes sleep quality.

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,” explains Guillén Díaz. “They go beyond a common sleep-quality claim by connecting sleep with some of the most relevant factors affecting consumers today. This is exactly what brands are looking for.”

The science behind RelaxPLX

RelaxPLX is supported by three dedicated randomised, placebo-controlled clinical studies focused on sleep and stress-related outcomes. These studies were conducted across different populations, including adults with sleep and stress concerns, adults with sleep disturbances, and adolescents experiencing mild sleep and stress-related challenges.

“These studies provide strong backing for RelaxPLX’s efficacy, showing that its clinical story is not based only on subjective consumer perception,” says Daniel González-Hedström, PhD, R&D Director for SUANNUTRA. “They combined validated questionnaires, objective sleep assessment, and physiological markers while addressing benefits that consumers can clearly understand—better sleep quality, stress-related balance, and feeling more restored in everyday life.”

Individual license approval by the MFDS of South Korea 

The MFDS is recognised as one of the world’s most rigorous authorities when it comes to bioactive ingredient approvals. The process to obtain individual license recognition in South Korea required a long-term commitment. It was a demanding, multi-stage project from dossier preparation through to final recognition. The objective was to demonstrate that a daily intake of 400mg/day of RelaxPLX’s® lemon verbena (Aloysia citrodora) extract may help to improve sleep quality.

To obtain this status, an ingredient must be clearly characterised, consistently manufactured, safe for human consumption, and supported by scientific evidence for the proposed functionality. The Korean authority evaluates the ingredient’s identity, origin, manufacturing process, quality specifications, active or marker compounds, analytical methods, stability, safety, and clinical trial evidence.

SUANNUTRA’s experts prepared a detailed documentation on the botanical source, extraction process, standardisation, analytical profile, quality controls, product specifications, physiological markers in specific studies, and safety data, in addition to clinical substantiation. Attention was focused on demonstrating that the ingredient submitted for recognition was consistent with the ingredient used in the clinical studies. SUANNUTRA worked in close collaboration with COSMAX BIO, whose local expertise was essential in navigating the Korean Health Functional Food framework.

“The individual license permits Korean brands using RelaxPLX to label their products with a sleep quality support claim,” explains 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 the Asia Pacific.”