Affron Saffron Extract Gains First Stress Relief Endorsement in South Korea

Pharmactive Biotech Products, S.L.U. is thrilled to announce that its flagship product, Affron®, a saffron extract, has received official approval from the South Korean Ministry of Food and Drug Safety (MFDS) for its stress relief benefits. This marks a significant achievement, making Affron® the first saffron ingredient to be licensed for this purpose in South Korea.

The rigorous approval process was carried out in collaboration with Hyundai Bioland Co., Ltd., a leader in the K-beauty and functional foods sector, based in Cheongju-si, Seoul. The endorsement permits Korean brands using Affron® to label their products as having stress management claims, which is a breakthrough for Pharmactive in the competitive nutraceutical landscape.

The Importance of MFDS Approval

The MFDS is recognized globally as one of the strictest regulatory bodies when it comes to approving health claims for bioactive products. According to María Muñoz, Head of Quality Assurance and Regulatory Affairs at Pharmactive, earning this approval represents a monumental regulatory success for the company. The MFDS enforces stringent standards that companies must meet, including clinical evidence and safety validation to obtain such health claims.

The approval process took over two years, requiring Pharmactive to provide extensive documentation that included the chemical composition and toxicological data of their saffron extract. This thorough scrutiny ensures that Affron® meets consistently high standards, thereby reinforcing consumer confidence in its health benefits.

Scientific Backing and Efficacy of Affron®

Pharmactive's extraction process utilizes a proprietary green extraction technology that preserves the powerful compounds of saffron while eliminating solvents. Their approach emphasizes standardized concentrations of Lepticrosalides®, responsible for saffron's health benefits. The scientific grounding for Affron's efficacy is bolstered by a solid evidence base, including 12 clinical trials involving over 1,000 participants. These trials have demonstrated the positive effects of Affron® on stress and mood improvement in various demographics, reinforcing its role as a go-to solution for stress management.

The Growing Demand for Stress Relief Solutions

In South Korea, stress is recognized as a critical health concern, with many consumers actively seeking natural remedies. The market for mental health products is valued at about USD 8.5 billion, with segments focusing on stress relief and sleep growing at an astounding rate. This rise in demand positions Affron® favorably within the booming nutraceutical market, projected to reach USD 27.3 billion by 2033.

Collaboration with Hyundai Bioland

Pharmactive's partnership with Hyundai Bioland has been instrumental in navigating the complexities of securing regulatory approval. Hyundai Bioland's expertise in health supplements, cosmetics, and biomedical ingredients has enhanced Pharmactive's regional momentum in South Korea, a critical market in Asia for health functional foods.

The approval allows Pharmactive to increase its presence within the rapidly expanding South Korean market, which is recognized for producing quality health supplements and is viewed as a model for nutraceuticals across Asia.

Commitment to Quality and Safety

At the core of Pharmactive’s philosophy is a commitment to quality and safety. The company employs high-performance liquid chromatography (HPLC) to ensure that their products meet precise standards and provide consistent health benefits. This meticulousness extends to preclinical studies conducted to understand the mechanisms through which Affron® impacts stress, demonstrating not just effectiveness but also safety across various populations.

Conclusion

This landmark achievement for Affron® underscores the growing recognition of natural products in promoting mental wellness. As the demand for stress-relief solutions escalates, Pharmactive Biotech's innovative saffron extract is poised to play a significant role in the health landscapes of South Korea and beyond, helping individuals achieve a more balanced and stress-free life.