New Milestone Sets Industry Benchmark for Akkermansia muciniphila Probiotic Safety.
SUZHOU, China , March 13, 2025 /PRNewswire-PRWeb/ — Thankcome Biological Science and Technology Co., Ltd, a subsidiary of Perfect Group (603059 CH), announced today that its probiotic ingredient, Akkermansia muciniphila AKK PROBIO™, has received dual self-affirmed GRAS (Generally Recognized as Safe) status following an independent review by experts in toxicology, microbiology, and food science. This certification affirms the safety of both live and inactivated forms of AKK PROBIO for use in conventional foods and beverages, meeting U.S. FDA standards under 21 CFR §170.30.
Key Highlights of the GRAS Certification
1. Comprehensive Safety Review
An independent panel of scientific experts conducted a thorough safety assessment of Akkermansia muciniphila AKK PROBIO™ and determined:
- Safe for Consumption – The probiotic is considered safe when consumed at 7.0×10¹⁰ AFU per serving, with a maximum daily intake of 1.3×10¹² AFU for a 70 kg adult.
- Manufactured Under cGMP Standards – The ingredient is produced in compliance with current Good Manufacturing Practices (cGMP) to ensure safety and consistency.
2. Market-Ready Applications
- Approved for inclusion in functional foods, beverages, and dietary supplements.
- Supports gut microbiome balance, metabolic health, and immune function.
- Recognized as a keystone gut bacterium, Akkermansia muciniphila plays a role in mucosal barrier integrity and immune modulation.
3. Regulatory and Scientific Backing
- The GRAS determination is based on peer-reviewed research, historical safety data, and stringent manufacturing standards.
- Aligns with U.S. regulatory frameworks, supporting Thankcome’s efforts to introduce safe and effective probiotic innovations to the global market.
“Achieving dual GRAS certification is a significant step forward in probiotic innovation,” said a spokesperson for Thankcome Biological Science and Technology Co., Ltd. “This recognition strengthens our mission to bring high-quality microbiome solutions to the global food and supplement industry.”
This milestone paves the way for collaborations with global food and supplement brands to integrate AKK PROBIO™ into formulations focused on digestive health, metabolic wellness, and immune support.
About Thankcome
Thankcome Biological Science and Technology Co., Ltd, a subsidiary of Perfect Group (603059 CH), is a leader in probiotic research and manufacturing. The company holds 101 Chinese patents, 4 PCT patents, and 4 Australian patents, focusing on microbial innovations that support health and wellness.
About AKK PROBIO™
AKK PROBIO™, developed by Thankcome, is a next-generation Akkermansia muciniphila probiotic with 8 granted Chinese patents (9 filed) and 6 Hong Kong patents. It is the first globally to receive dual U.S. GRAS certifications for live and inactivated forms, ensuring compliance with the highest safety standards. Backed by peer-reviewed research and proprietary safety studies, AKK PROBIO™ is designed to support metabolic, gut, and immune health.
For more information, visit http://www.thankcome.com.
Media Contact
Susanna Geng, Thankcome Biological Science and Technology Co., Ltd, +86 512-57010600, [email protected], http://www.thankcome.com/
SOURCE Thankcome Biological Science and Technology Co., Ltd
