Monteloeder’s RelaxPLX sleep support claims approved in Canada and South Korea

Monteloeder by SuanNutra’s RelaxPLX lemon verbena (Aloysia citrodora) ingredient has received individual license approval for its sleep quality support claim by South Korea’s Ministry of Food and Drug Safety (MFDS). It has also been approved by 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,” says 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.”

Rigorous South Korean approval process

Monteloeder says it underwent a long process to obtain individual license recognition in South Korea, detailing it was a “demanding, multi-stage project” from dossier preparation through to final recognition.

Mariana Ortega, science marketing manager for SuanNutra, hails the achievement as a significant step forward for SuanNutra in the broader Asia-Pacific regional market.

For an ingredient to be approved under the MFDS system, it must be clearly characterized, 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.

In Canada, the ingredient is approved to improve sleep, relieve stress symptoms, and reduce cortisol.Through this process, the company was required to demonstrate that a daily intake of 400 mg/day of RelaxPLX’s lemon verbena extract can help boost sleep quality.

SuanNutra experts prepared detailed documentation on the botanical source, extraction process, standardization, analytical profile, quality controls, product specifications, and physiological markers in specific studies. They also showcased safety data in addition to clinical substantiation.

The experts also demonstrated that the ingredient submitted for recognition was consistent with the ingredient used in the clinical studies. SuanNutra says it worked in close collaboration with Cosmax Bio, whose local expertise was essential in navigating the Korean Health Functional Food framework.

Daniel González-Hedström, Ph.D., R&D director for SuanNutra, says the company’s studies provide strong backing for RelaxPLX’s efficacy, showing that its clinical story is “not based only on subjective consumer perception.” 

“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.”

Health Canada claims

In Canada, supplement manufacturers using Monteloeder’s ingredient can claim that it helps improve sleep quality for adolescents with stress and for people with mild anxiety. Other claims are that it temporarily relieves symptoms of perceived stress and helps reduce cortisol.

RelaxPLX is backed by three dedicated randomized, placebo-controlled clinical studies centered on sleep and stress-related benefits. 

These studies involved various demographics, including adults with sleep and stress concerns, adults with sleep disturbances, and adolescents struggling with mild sleep and stress-related challenges.

“These claims differentiate RelaxPLX positioning because they combine two highly relevant consumer concerns: sleep quality and stress-related well-being,” says 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.”

Trending sleep supplements

Monteloeder highlights that sleep and stress support remain two of the fastest-growing segments in the functional ingredients space. Increasingly, it underscores that formulators are seeking science-backed, natural compounds that address these needs without unwanted side effects or reliance on synthetic interventions.

Previously, Nutrition Insight hosted a webinar with Monteloeder to discuss how manufacturers of sleep aids, calming blends, and mood-support supplements can utilize RelaxPLX as a flexible solution that meets the evolving consumer expectations for natural, safe, and effective wellness products.

Monteloeder also features lemon verbena in a proprietary botanical blend for weight control, which includes hibiscus. One trial found that participants using this ingredient reported positive shifts in their motivation around weight management, as well as emotional stability. They also reported fewer cravings, less emotional eating, improved eating habits, and sustained motivation.