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RelaxPLX Gains Regulatory Approval in South Korea and Canada

Monteloeder, a subsidiary of SUANNUTRA, has secured two significant regulatory wins for its lemon verbena extract, RelaxPLX. The ingredient received individual license approval for sleep quality support from South Korea’s Ministry of Food and Drug Safety, alongside a new Product License in Canada covering multiple sleep and stress-related health claims.

RelaxPLX Gains Regulatory Approval in South Korea and Canada
Photo: Bio & News

The South Korean approval process required a rigorous multi-stage evaluation of the ingredient's identity, manufacturing consistency, and safety. By demonstrating that a 400mg daily intake of the extract improves sleep quality, the company successfully navigated the country's strict Health Functional Food framework with the assistance of local partner COSMAX BIO. This milestone enables Korean brands to officially label products containing the ingredient with sleep support claims, expanding the company's footprint across the Asia-Pacific region.

In Canada, the new product license provides a specific framework for marketing, allowing the company to promote the ingredient for managing perceived stress and reducing cortisol levels. These claims, which also extend to sleep quality improvements for adolescents and individuals with mild anxiety, are supported by three randomized, placebo-controlled clinical trials. According to R&D Director Daniel González-Hedström, the clinical validation relies on a mix of physiological markers and objective assessments rather than subjective reports. These endorsements serve as the foundation for the company's Visible Balance platform, designed to help supplement brands position their products around restorative sleep and daily stress management.

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