Maypro Completes NDI Notification Process for AKK Probio Akkermansia

Maypro announced that its Akkermansia muciniphila ingredient, AKK Probio, has been approved by the U.S. Food and Drug Administration (FDA) via the New Dietary Ingredient Notification (NDIN) process.

According to the ingredient developer, Thankcome Biological Science and Technology, AKK Probio is the first strain of its kind, of human intestinal origin, to complete the NDIN pathway to market.

The NDIN process requires safety documentation, strain characterization, manufacturing controls, toxicological assessments, and supporting scientific evidence, covering quality, safety, and scientific substantiation.

“The successful completion of the FDA NDI review represents an important milestone in the evolution of Akkermansia muciniphila from promising microbiome research to commercial reality,” said Abhijit Natu, vice president of U.S. nutrition at Maypro. “Supported by an expanding portfolio of human clinical studies, peer-reviewed publications, and intellectual property, AKK Probio is helping define a new class of clinically substantiated microbiome ingredients. This achievement provides brands with greater confidence to develop innovative products focused on metabolic health, gut health, weight management, and healthy aging, backed by both robust scientific evidence and a clear regulatory pathway.”

AKK Probio has been deposited in internationally recognized microbial culture collections across the United States, Germany, Australia, and China, providing independent verification of the strain’s identity and ensuring long-term preservation, reproducibility, regulatory documentation, and global commercialization.

“As the first gut-derived Akkermansia muciniphila strain to complete the FDA NDI process, AKK Probio reflects our long-term commitment to scientific excellence, product safety, and regulatory compliance,” said Chris Yu, founder at Thankcome. “We are proud to partner with Maypro to bring this innovative ingredient to the U.S. market and help meet growing demand for next-generation microbiome solutions backed by rigorous research and quality standards.”

AKK Probio was introduced to the U.S. market at SupplySide Global last year, and was recognized by the event as Ingredient of the Year in the weight management category. It is supported by 7 human clinical studies and several other peer-reviewed publications, and is protected by 18 patents.

Research on AKK Probio strains includes health outcomes such as measures of metabolic health and obesity, GLP-1 support, women’s metabolic health, gut-brain axis, mood, sarcopenia, and healthy aging.