RelaxPLX® Secures Health Canada and South Korea Licenses for Sleep Support

RelaxPLX® Secures Health Canada and South Korea Licenses for Sleep Support



Monteloeder, SL, a subsidiary of SUANNUTRA SA, recently announced a landmark achievement for its flagship product, RelaxPLX®. This innovative formulation has officially received regulatory approval from Health Canada and the Ministry of Food and Drug Safety (MFDS) of South Korea for sleep quality support claims. This dual recognition marks a significant milestone for the company, reinforcing RelaxPLX®'s credibility in both North American and Asian markets.

Regulatory Approval in Canada and Korea



RelaxPLX® is now equipped with an authorized claims framework in Canada’s competitive supplement market, recognized for its rigor in product safety and efficacy. The approved health claims highlight the ingredient’s capabilities in multiple aspects of sleep quality and stress management. These include:
  • - Improvement of sleep quality.
  • - Alleviation of sleep disturbances that may negatively affect overall sleep.
  • - Temporary relief of perceived stress symptoms.
  • - Reduction of cortisol, a key biomarker of stress.
  • - Enhanced sleep quality for adolescents facing stress.
  • - Support for individuals experiencing mild anxiety.

Stephanie Guillén-Díaz, Chief Commercial Officer of SUANNUTRA, emphasized that these claims extend beyond typical sleep quality assurances. By integrating factors related to sleep and stress management, RelaxPLX® caters to contemporary consumer concerns—creating substantial interest among health supplement brands.

Supported by Scientific Research



The efficacy of RelaxPLX® is grounded in rigorous clinical research. Three randomized, placebo-controlled studies have examined its impact on sleep and stress amongst diverse populations. These studies demonstrated the ingredient’s ability to positively influence sleep quality, showing robust evidence derived from validated questionnaires, objective sleep assessments, and physiological markers. According to Dr. Daniel González-Hedström, the Director for SUANNUTRA, these studies underscore that RelaxPLX®’s benefits are measurable and relatable, addressing a significant consumer need for improved sleep and balanced stress levels.

Individual License Approval in South Korea



Obtaining individual license status from the MFDS entails an extensive and challenging process codifying the safety, consistency, and scientific backing of a product. In South Korea, RelaxPLX® underwent a comprehensive evaluation process that examined critical elements, including identity, manufacturing processes, quality specifications, and clinical trial data. The MFDS recognizes the stringent criteria involved in approving bioactive ingredients, making this achievement especially noteworthy. The individual license allows Korean brands to label their products with sleep quality support claims, a significant advance in the Asian Pacific market.

Visible Health Platform



In conjunction with these approvals, SUANNUTRA has launched the Visible Health Platform, aimed at translating clinical data into comprehensible benefits for everyday consumers. A key focus within this framework is the Visible Balance platform, dedicated to enhancing restorative sleep and promoting healthy stress management—an aspect consumers seek closely related to their overall well-being. Through RelaxPLX®, brands will be empowered to create products that not only resonate with scientific integrity but also appeal to the emotional and practical needs of consumers.

Monteloeder's achievements in Canada and South Korea are paving the way for increased awareness and acceptance of scientifically backed sleep support supplements in global health markets. With a foundation built on substantial clinical evidence, RelaxPLX® stands poised to meet the needs of today's individuals in a world where quality sleep is paramount. As discussions for partnerships advance globally, the future looks bright for RelaxPLX® as it leads the charge in innovative nutritional support for sleep and stress management.

For more information, visit Monteloeder or their press department.

Topics Health)

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