Monteloeder looks to fill gaps in sleep support following latest regulatory approvals

Asia is one of the most dynamic regions for sleep support innovation, with category growth driven by rising stress levels, demanding work cultures, greater awareness of sleep health, aging populations, digital lifestyles, and increasing consumer interest in non-pharmaceutical wellness solutions. In South Korea particularly, consumers are highly engaged with preventive health and science-backed products. It is also a market where quality, regulatory credibility, and innovation carry weight. This is according to Tomás Muñoz Gutiérrez, Commercial Director (APAC) at Monteloeder, who spoke to NutraIngredients following the recent approval of RelaxPLX by South Korea’s Ministry of Food and Drug Safety (MFDS). He said that there remains several gaps in the sleep support category, with the first being the room to move beyond generic relaxation claims. “Many products still speak broadly about relaxation, but consumers and brands are increasingly looking for ingredients with clinical evidence specifically linked to sleep quality,” he explained. “There is also growing interest in non-melatonin alternatives. Some consumers want sleep-support options that fit into a daily wellness routine without relying only on melatonin.” In addition, the stress-sleep connection is becoming more important. Although consumers increasingly understand that stress and sleep are linked, many products still address them separately. At the same time, there is a need for more measurable, science-backed benefits, leading to brands looking for ingredients supported by validated questionnaires, biomarkers or objective sleep measurements. “Finally, there is room for innovation in formats and audiences. Sleep support is moving beyond traditional capsules into gummies, powders, stick packs, beverages, and evening ritual formats. It is also becoming relevant for younger consumers, including students and young professionals, not only older adults.” RelaxPLX is said to address these gaps in various ways. With lemon verbena extract as its main active ingredient, it offers a botanical option in a category where many products still rely on broad relaxation positioning, and in a market often dominated by melatonin or conventional relaxation ingredients. It also aligns with consumer demand for plant-based and science-backed wellness solutions. RelaxPLX is backed by clinical studies in different populations, including adults and adolescents. This gives brands the opportunity to develop more targeted products for different consumer needs, rather than relying on a one-size-fits-all approach. The clinical evidence also supports sleep-quality outcomes and stress-related well-being, making it relevant for consumers who recognize the relationship between sleep and stress. The Visible Health Platform is a strategic framework designed by SuanNutra to translate clinical science into tangible benefits that consumers can understand and integrate into their everyday lives. One of its three categories is Visible Balance, whereby sleep quality and stress balance are benefits people can experience in their daily life—waking up more restored, feeling more balanced, and better management of occasional stress. As part of Visible Balance, RelaxPLX helps address these two pillars of everyday well-being, making it especially appealing to brands seeking to develop next-generation products that are not only science-backed, but also emotionally attractive and applicable to consumers. Apart from the individual recognition as a functional ingredient for its sleep quality support by the MFDS, RelaxPLX has also attained a Health Canada Product License for multiple sleep and stress claims. The process from dossier preparation through to final MFDS approval was completed in approximately 10 months, which is considered a “very efficient timeline for this type of regulatory pathway” in the country. Gutiérrez said this was made possible due to a combination of factors. “From SuanNutra’s side, we were able to provide a strong and well-organized evidence package early in the process, including comprehensive clinical and statistical data supporting RelaxPLX’s sleep-quality positioning,” he added. “In parallel, additional mechanistic work helped reinforce the clinical findings and provided further scientific consistency across the dossier.” The collaboration with Korean ODM major COSMAX BIO was also essential. “Their experience with MFDS individual recognition submissions, together with their understanding of local regulatory expectations, helped ensure the dossier was structured and presented appropriately from the outset. “For us, this was a very strong example of how international ingredient science and local regulatory expertise can work together effectively. SuanNutra contributed the ingredient science, clinical evidence and technical background, while COSMAX BIO provided the local regulatory knowledge needed to navigate such a demanding process in Korea.” Upon the MFDS approval, Monteloeder is now focused on supporting the commercial development of RelaxPLX in South Korea together with COSMAX BIO. The company is seeing strong interest from Korean brands and manufacturers looking for clinically supported sleep health ingredients with a clear regulatory pathway. “The recognition gives RelaxPLX a much stronger and credible position in the health functional food market and for Korean brand adoption. This is important because Korean consumers and companies place strong value on science, compliance and official validation,” Gutiérrez said. “It also boosts the confidence of and strengthens discussions with Korean manufacturers, brand owners and distributors. For many companies, the fact that an ingredient has gone through this type of review can reduce uncertainty and accelerate product development and commercial conversations.” Beyond Korea, the company believes this milestone supports its broader APAC strategy for RelaxPLX to build a clinically supported botanical platform for sleep quality and stress-related well-being that can be adapted to local market needs, regulatory frameworks, and product formats. “Korea is an influential market for functional foods, beauty-from-within, and health innovation. Ingredients validated here can have an impact in neighboring markets, especially where Korean wellness trends and K-health innovations are closely followed.”

Monteloeder looks to fill gaps in sleep support following latest regulatory approvals

SuanNutra-owned Monteloeder seeks to fill existing gaps in the sleep support category on the back of regulatory approval of its proprietary RelaxPLX ingredient in South Korea.

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