Monteloeder’s RelaxPLX Gains Health Canada License, South Korean Approval for Sleep Support Claim

RelaxPLX, a lemon verbena ingredient marketed by Monteloeder, received individual license approval for its sleep quality support by the Ministry of Food and Drug Safety of South Korea, and a Health Canada Product License for multiple claims related to sleep and stress.

“Attaining these health claims is an important regulatory milestone for RelaxPLX in North America and Asia Pacific,” said Stephanie Guillén-Díaz, chief commercial officer at Suannutra, Monteloeder’s parent company. “This strengthens the ingredient’s credibility and provides a valuable platform for business development with Canadian, South Korean and international partners.”

Health Canada Approval

The Health Canada Product License gives RelaxPLX authorized claims, including:

• 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’s positioning because they combine two highly relevant consumer concerns: sleep quality and stress-related well-being,” said 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.”

South Korean Approval

MFDS approval requires a long-term commitment. The process involved a multi-stage project, to establish that a daily intake of 400 mg/day of RelaxPLX’s lemon verbena extract may help improve sleep quality.

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

Suannutra’s experts presented documents on the botanical source, extraction process, standardization, analytical profile, quality controls, product specifications, physiological markers in studies, safety data, and clinical substantiation. The focus was on demonstrating that the ingredient submitted for recognition was consistent with that used in clinical studies. The company collaborated closely with Cosmax Bio, which had local expertise in navigating Korean Health Functional Food regulations.

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

Scientific Substantiation

RelaxPLX is supported by three randomized, placebo-controlled studies focused on sleep and stress-related outcomes. The studies were conducted across different populations: adults with sleep and stress concerns; adults with sleep disturbances; and adolescents with 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,” said 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.”