EquoYouth™ S-Equol Achieves Self-Affirmed GRAS Status

Changsha, China – October 12, 2025 – Bonerge announces that its proprietary EquoYouth^™ S-equol has achieved Self-Affirmed GRAS (Generally Recognized As Safe) status following a comprehensive evaluation conducted by an independent Expert Panel qualified in food safety and toxicology.

The GRAS determination was conducted in accordance with 21 CFR §170.3(b), based on scientific procedures and publicly available safety data.

After reviewing toxicology studies, human clinical data, manufacturing processes and product specifications, the Expert Panel unanimously concluded that EquoYouth^™ S-equol meets the standard of “reasonable certainty of no harm” under its intended conditions of use.

Science-Based Safety Determination

According to the evaluation dossier:

• Intended daily intake: 10–12 mg (divided into two doses)

• Human studies reported no adverse effects at doses up to 30 mg/day for 12 weeks

• Long-term data demonstrated safety at 10 mg/day for one year

• Animal NOAEL levels significantly exceeded the proposed intake level

The Panel further confirmed that EquoYouth™ S-equol, when produced in compliance with current Good Manufacturing Practice (cGMP) and meeting established specifications, is safe for use as a food and/or dietary ingredient, excluding pregnant and lactating women.

High-Purity Production and Fermentation Innovation

Produced through proprietary microbial fermentation, EquoYouth^™ delivers >99% pure S-enantiomer, structurally identical to endogenous equol generated in the human body. The manufacturing process strictly adheres to GMP standards, ensuring batch consistency, quality stability and scalable supply capability.

Through continued investment in fermentation technology and process optimization, Bonerge has established large-scale commercial production capacity to support global brand partners.

Statement from Product Management

The achievement of Self-Affirmed GRAS status marks an important step in EquoYouth^™’s regulatory development and global market expansion. It reinforces Bonerge’s long-term strategy of combining scientific validation with regulatory rigor.

“Achieving Self-Affirmed GRAS status represents a significant milestone for EquoYouth^™. It reflects our long-term commitment to safety research, regulatory compliance and fermentation innovation. For our partners, this milestone provides greater confidence in compliance readiness, supply reliability and sustainable market development.”

Gloria, Product Manager at Bonerge.

With this regulatory foundation in place, EquoYouth^™ is positioned to support brand partners seeking reliable, science-backed women’s health solutions in the U.S. and beyond.

Regulatory Commitment and Market Positioning

Since 2017, highly purified S-equol products have been marketed internationally with strong safety records. The GRAS determination further strengthens EquoYouth^™’s regulatory standing in the United States, supporting its application in food and dietary supplement categories.

In a market increasingly focused on scientific validation and regulatory clarity, EquoYouth™ represents not only a functional ingredient, but also a long-term commitment to quality, safety and compliance excellence.

To learn more about EquoYouth^™ S-equol specifications, safety documentation and application support, please visit the product detail page.