Pharmactive Biotech has received official license approval for its potential to relieve stress from South Korea’s Ministry of Food and Drug Safety (MFDS). The process was conducted in partnership with Hyundai Bioland, a leading company in K-beauty and functional foods.

The approval positions Affron as the first saffron ingredient to be approved for a stress relief claim by the South Korean food regulatory authority, and is currently the only holder of a stress relief claim recognition, the company reported. Supplements containing Affron can bear a Health Functional Food (HFF) seal, confirming its benefits.

Stress is ranked as a leading health category in Korea for which many consumers are seeking a natural solution, and the individual license permits Korean rands to label their products with stress management claims, representing a significant breakthrough for Pharmactive.

“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,” said 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.”

For a health claim license, MFDS defines specific claims for each health category and provides parameter tables that must be met in order to obtain approval. These typically include specific biomarkers, mechanisms of action, clinical evidence, and safety validation. MFDS also specifies which types of studies are accepted to fulfill these parameters.

 The approval process for Affron took more than two years, in which Pharmactive submitted a dossier detailing the botanical’s chemical fingerprint and toxicological data, and a full history of pre-clinical and clinical trials.

Affron offers the lowest dose of saffron with clinical efficacy on the market. The company uses a solvent-free green extraction technology, achieving standardized concentrations of Lepticrosalides, the compounds responsible for saffron’s bioactive benefits.

In line with MFDS requirements, analytical tools were applied to ensure that Affron met a consistent molecular pattern. The pattern aligned with material used in clinical studies to demonstrate a responsible chemical fingerprint. Specifically, high-performance liquid chromatography (HPLC) was used to obtain a comprehensive characterization of crocin isomers and other key compounds.

 An analytical study on 88 industrial batches revealed consistent crocin/picrocrocin profiles. Quality and profile were maintained over a storage period of up to 36 months, and Affron’s safety was demonstrated through a weight-of-evidence approach combining high-dose animal studies, mechanistic liver safety data, and human clinical experience.

“Affron’s safety and efficacy are supported by a solid evidence base, comprising 12 clinical trials on 1,000-plus total participants,” said Marina Diez, head of R&D and quality control 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.”

“South Korea was strategically important for us,” said Lim Tian Cai, business development manager for the APAC region. “This is not only because it is a premier cross-border nutraceutical manufacturing hub in Asia but also home to a regulatory that is considered a gold standard. MFDS-granted health claims are highly respected by the locals. Moreover, ‘Korea-made’ is highly valued across Asia and beyond. Finished products emanating from there are making significant inroads into Asian markets given Korea’s reputation as an advanced and high-trust market for Health Functional Foods.”