Monteloeder, a subsidiary of SuanNutra has expanded the commercial reach of its botanical sleep ingredient RelaxPLX after securing a Health Canada Product Licence and obtaining individual functional ingredient recognition from South Korea's Ministry of Food and Drug Safety (MFDS).
The regulatory milestones allow the company's lemon verbena (Aloysia citrodora) extract to be marketed with approved sleep quality claims in both regions, strengthening its position in two strategically important nutraceutical markets.
In Canada, RelaxPLX received a Product Licence covering a range of sleep and stress-related health claims, including support for sleep quality, temporary relief of perceived stress, reduction of cortisol levels and improvements in sleep quality among individuals experiencing mild anxiety or stress-related sleep disturbances.
Health Canada licences are awarded only after products have been assessed for safety, efficacy and quality, making them a significant commercial and regulatory benchmark for ingredient suppliers.
According to Stephanie Guillén-Díaz, Chief Commercial Officer at SuanNutra, the approvals provide a stronger platform for collaboration with supplement brands in North America and Asia-Pacific.
"These claims differentiate RelaxPLX positioning because they combine two highly relevant consumer concerns: sleep quality and stress-related wellbeing," she said.
They go beyond a common sleep-quality claim by connecting sleep with some of the most relevant factors affecting consumers today.
The ingredient is supported by three randomised, placebo-controlled clinical studies evaluating sleep and stress outcomes across adults and adolescents.
According to the company, the trials incorporated validated questionnaires, objective sleep assessments and physiological biomarkers.
"These studies provide strong backing for RelaxPLX’s efficacy, showing that its clinical story is not based only on subjective consumer perception,” said Dr Daniel González-Hedström, R&D Director for SuanNutra.
The South Korean approval follows a multi-stage review process under the country's Health Functional Food framework, which required SuanNutra to demonstrate the identity, safety, manufacturing consistency and clinical efficacy of RelaxPLX.
The ingredient can now be marketed in South Korea with the authorised claim that it "may help to improve sleep quality".
The recognition was achieved in collaboration with Korean partner COSMAX BIO and is expected to support expansion opportunities across the wider Asia-Pacific region, with the company saying the recognition gave "RelaxPLX a strong and locally validated position in the Korean sleep-quality category."
The company is positioning RelaxPLX within its "Visible Balance" platform, which focuses on delivering measurable benefits linked to restorative sleep, stress resilience and everyday wellbeing.
The approvals come as demand for sleep and stress management solutions continues to grow globally.
South Korea's nutraceutical market is forecast to expand from approximately $13.6bn in 2025 to $27.3bn by 2033, driven by an ageing population and rising health awareness.
SuanNutra noted that sleep quality and stress management are becoming increasingly interconnected priorities for consumers in South Korea.
Speaking to Nutraceutical Business Review, a spokesperson for the company said it has seen "strong and sustained momentum in both the sleep quality and stress-related wellbeing categories in South Korea."
Recent industry data indicate that the South Korean sleep-support category is expected to continue [to grow] over the coming years, driven by increasing awareness of sleep health, high stress levels, an ageing population and growing interest in natural, science-backed wellness solutions.
"Consumers are increasingly looking for products that can support sleep quality as part of a healthier daily routine, without relying exclusively on pharmaceutical approaches."
SuanNutra expects the demand to continue, particularly for "clinically supported, plant-based ingredients that fit within South Korea’s growing wellness and self-care culture."
Consumer preferences are moving beyond general relaxation towards measurable, science-backed benefits, creating opportunities for innovative nutraceutical solutions that connect sleep quality, stress-related wellbeing and everyday visible health.
For nutraceutical brands, the latest approvals provide new opportunities to formulate products with authorised claims in two highly regulated markets while capitalising on growing consumer demand for evidence-based sleep health solutions.
