Pharmactive Biotech Products secures first MFDS-approved stress relief claim in South Korea for Affron

Editor’s Note: This article has been updated on February 19, 2026 at 5:22pm to add an AI disclosure.

Pharmactive Biotech Products, S.L.U. has secured a new regulatory milestone in Asia, as its branded saffron extract Affron received an individual license approval for stress-relief claims from South Korea’s Ministry of Food and Drug Safety (MFDS), a February 17 press release from the company announced.¹ The decision positions the ingredient as the first saffron-derived material authorized for a stress-related health claim in the country, the company states. Supplements marketed in South Korea that contain the ingredient now certified to display a Health Functional Food (HFF) seal. The approval follows a multiyear dossier review conducted in partnership with Hyundai Bioland, a regional manufacturer and producer of functional foods.

License approval process

The new approval indicates that Affron is regulated and scientifically-backed as a health-benefit food by the South Korean government, the press release states.

For Pharmactive Biotech Products, the designation underscores both regulatory rigor and scientific substantiation. “This designation marks a major regulatory victory for Pharmactive, as the MFDS is noted to be among the world’s most rigorous authorities when it comes to bioactive product approvals,” stated María Muñoz, head of quality assurance and regulatory affairs at Pharmactive. “To earn this endorsement, companies must demonstrate that their products meet the highest standards of quality, efficacy, and safety through a uniquely demanding and lengthy screening process.”

Submissions for a license typically must meet thorough parameter tables, the press release explains, including biomarkers, mechanisms of action, clinical evidence, and safety validation.

Affron’s dossier submission

Affron’s dossier combined chemical fingerprinting and toxicological data, with a portfolio of preclinical and clinical investigations. High-performance liquid chromatography profiling confirmed consistent crocin and picrocrocin composition, and analytical testing across more than 80 industrial batches and demonstrated stability in the profiles for up to 36 months. Safety conclusions incorporated high-dose animal studies, mechanistic liver data, and accumulated human clinical experience.

Clinical validation and research on mood

Clinical substantiation formed a central component of the MFDS evaluation. “Affron’s safety and efficacy are supported by a solid evidence base, comprising 12 clinical trials on 1,000+ total participants” explains Marina Diez, head of R&D And Qc at Pharmactive. “Results of pharmacokinetic studies demonstrate the bioavailability of key metabolites, such as crocetin. Several preclinical studies focused specifically on stress-response biology, helped identify important mechanisms of action. From this overall body of evidence, at least four human trials specifically confirmed Affron’s benefits on occasional stress and mood. Moreover, Affron was tested on diverse populations, including healthy adults, adolescents, and perimenopausal women.”

One in vivo study using a chronic stress model with rodent subjects helped identify the mechanism of action for Affron, namely, supporting the regulation of the body’s stress-response system, the hypothalamic–pituitary–adrenal (HPA) axis. The study results suggested a reduction in stress hormone signaling through lower corticosterone levels.

Additionally, a randomized, double-blind, placebo-controlled trial, published in The Journal of Nutrition in May 2025 demonstrated reductions in Depression, Anxiety, and Stress Scale compared to placebo after 12 weeks of daily supplementation with Affron.²

Value of license in Korean market

Commercially, the authorization arrives as stress management emerges as a priority health category among Korean consumers, the company adds, referencing data showing the country’s nutraceutical sector is valued at roughly $14.8 billion and is projected to approach $27.3 billion by 2033, with mental wellness and sleep-related functional foods among the fastest-expanding segments.

“South Korea is a strategically important market for us,” states Lim Tian Cai, business development manager in APAC. “This is not only because it is a premier cross-border nutraceutical manufacturing hub in Asia but also home to a regulatory authority that is considered gold standard. MFDS-granted health claims are highly respected by the locals.”

This article was created with assistance from AI. The content has been reviewed and edited by Erin McEvoy, Associate Editor. For more information on the extent and nature of AI usage, please contact us.

References

1. PharmActive Biotech Products. Affron Saffron Attains First Stress Relief Claim by South Korean Ministry of Food and Drug Safety. February 17, 2026. (Accessed 2026-02-19).
2. Lopresti, AL.; Smith, SJ.; Marx, W.; Díez-Municio, M.; Morán-Valero, MI. An Examination into the Effects of a Saffron Extract (Affron) on Mood and General Wellbeing in Adults Experiencing Low Mood: A Randomized, Double-Blind, Placebo-Controlled Trial, The Journal of Nutrition. 2025. DOI: 10.1016/j.tjnut.2025.05.024.