Lemon Verbena Ingredient RelaxPLX Secures Sleep and Stress Claims in Canada and South Korea

Monteloeder’s lemon verbena ingredient RelaxPLX has received a Health Canada Product License covering multiple sleep and stress-related claims, alongside individual license approval from South Korea's Ministry of Food and Drug Safety, specifically for a sleep quality support claim.¹

The clearance by the SUANNUTRA subsidiary provides authorized claims language backed by government review in two markets where supplement health claims typically require a formal premarket regulatory process rather than self-substantiation.

"Attaining these health claims is an important regulatory milestone for RelaxPLX in North America and Asia Pacific," said 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."

What Clinical Evidence Supports RelaxPLX's Sleep and Stress Claims?

RelaxPLX is derived from Aloysia citrodora, commonly known as lemon verbena, standardized for its verbascoside content, a polyphenol compound associated with antioxidant, anxiolytic, and sedative properties in prior pharmacological research. According to the company states, the ingredient is supported by 3 dedicated randomized, placebo-controlled clinical studies addressing sleep and stress-related outcomes.

One of these trials, a single-center, randomized, double-blind, placebo-controlled study published in 2024 in the peer-reviewed journal Nutrients, enrolled 71 healthy adults with sleep disturbances and administered 400 mg per day of the lemon verbena extract or placebo for 90 days.²

Compared with placebo, the treatment group showed statistically significant improvements in visual analogue scale ratings of sleep quality, overall Pittsburgh Sleep Quality Index scores, and both sleep latency and sleep efficiency. Actigraphy-based measurements corroborated these self-reported outcomes, and plasma nocturnal melatonin levels increased significantly in the treatment group relative to placebo.

The 400 mg per day dose used in this trial matches the dose Health Canada and the Ministry of Food and Drug Safety required the company to substantiate for its respective regulatory submissions.

"These studies provide strong backing for RelaxPLX's efficacy, showing that its clinical story is not based only on subjective consumer perception," noted Daniel González-Hedström, PhD, SUANNUTRA’s research and development director. "They combined validated questionnaires, objective sleep assessment, and physiological markers while addressing benefits that consumers can clearly understand."

How Do the Authorized Claims Differ Between Health Canada and South Korea?

The two regulatory clearances are not identical in scope. The Health Canada Product License permits a broader set of approved claims, including statements that the ingredient helps improve sleep quality, helps improve symptoms of sleep disturbance, temporarily relieves symptoms of perceived stress, helps reduce cortisol as a biomarker of physical stress, helps improve sleep quality in adolescents experiencing stress, and helps improve sleep quality in individuals with symptoms of mild anxiety.

The South Korean Ministry of Food and Drug Safety approval is narrower in scope, authorizing specifically a sleep quality support claim under that country's Health Functional Food framework, which the company has described as one of the more demanding regulatory review processes globally for bioactive ingredient claims.

This distinction matters for manufacturers operating across both markets, since claims language authorized in one jurisdiction does not automatically transfer to the other, and companies marketing RelaxPLX-containing products in both countries will need to apply the specific claims language approved within each respective regulatory framework.

What Is the Broader Market and Clinical Context for Sleep and Stress Supplements?

Sleep disturbance and chronic stress are widely prevalent and often overlapping conditions, and supplement categories addressing either concern have grown considerably as consumers seek alternatives to prescription sleep aids and anxiolytics.

Lemon verbena's proposed mechanism involves modulation of stress-related hormonal pathways, including cortisol, alongside effects on melatonin secretion relevant to sleep onset and maintenance, though the precise molecular targets of verbascoside and related compounds have not been fully characterized in human pharmacodynamic studies.

What Limitations Should Manufacturers Consider?

The principal clinical trial supporting these claims enrolled 71 participants, a modest sample size for establishing generalizable efficacy, and the study population consisted of generally healthy adults with self-reported sleep disturbances rather than individuals with clinically diagnosed sleep or anxiety disorders.

The announcement does not specify whether the adolescent-specific claim authorized by Health Canada is supported by a study population that included adolescent subjects, an important distinction for manufacturers considering formulations targeted at that age group. Additionally, regulatory authorization of a health claim in Canada or South Korea reflects each agency's own evidentiary standards and does not constitute equivalent substantiation under other regulatory frameworks, including the structure-function claim system used in the United States.

References

1. Pérez-Piñero S, Muñoz-Carrillo JC, Echepare-Taberna J, et al. Dietary supplementation with an extract of Aloysia citrodora (lemon verbena) improves sleep quality in healthy subjects: a randomized double-blind controlled study. Nutrients. 2024;16(10):1523. doi:10.3390/nu16101523

2. Monteloeder, SL. RelaxPLX gains Health Canada license, and South Korean sleep quality support claim PR Newswire. June 24, 2026. Accessed June 24, 2026. https://www.prnewswire.com/news-releases/relaxplx-gains-health-canada-license-and-south-korean-sleep-quality-support-claim-302809186.html