Pharmactive Biotech has announced that its flagship offering, Affron saffron extract, has been granted individual license approval for its potential to relieve stress by the Ministry of Food and Drug Safety (MFDS) of South Korea.
The process was conducted in collaboration with Hyundai Bioland Co, Cheongju-si, Seoul, a leading company in K-beauty and functional foods.
The endorsement now positions Affron as the first saffron ingredient to be approved for a stress relief claim by the South Korean food regulation authority. The company says that the product is, to date, the only holder of this recognition.
In South Korea, supplements containing Affron must bear a Health Functional Food (HFF) seal, which confirms the ingredient is regulated and approved by the Korean government as a health-benefit food that has been scientifically vetted.
Stress is currently ranked as a key health category in Korea for which many consumers are seeking a natural solution.
The individual license permits Korean brands using Affron to label their products with stress management claims, representing a huge 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."
The approval process stretched to more than two years. Pharmactive was required to submit a comprehensive dossier detailing their branded botanical’s chemical fingerprint and toxicological data, as well as a full history of pre-clinical and clinical trials.
South Korea emerging as a core market
"South Korea is a strategically important market for us," added 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 the 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 Asians markets, given Korea’s reputation as an advanced and high-trust market for Health Functional Foods."
Korea’s nutraceutical market is currently valued at approximately $14.8bn and is projected to reach $27.3bn by 2033, with 2026-2033 year-on-year growth above nine per cent, significantly outpacing the global average.
The South Korean market for mental health- and stress-related products is already dynamic.
The broader mental health services and products market in South Korea is valued at approximately $8.5bn. Within that, the "Stress Relief & Sleep" segment of the Health Functional Food (HFF) market is growing at a CAGR of more than ten per cent.
Deepening its market development in South Korea and across Southeast Asia, Pharmactive entered into collaborations with Hyundai Bioland Co, a comprehensive healthcare company specialising in the production and sales of health supplements, cosmetics and biomedical ingredients.
The biotech firm has been instrumental in driving Pharmactive’s regional expansion while steering them through the bureaucratic landscape to secure the coveted MFDS seal.
Additionally, Affron is backed by twelve human trials, bolstering its scientific credentials.
"Affron’s safety and efficacy are supported by a solid evidence base, comprising twelve clinical trials on 1000+ total participants," said 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 and 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."