Bifido, a local microbiome company, said Tuesday that the U.S. Food and Drug Administration (FDA) has approved its human-derived Bifido bacteria BGN4 as a new dietary ingredient (NDI).
The NDI certification is a procedure that requires companies to demonstrate the safety of raw materials to the FDA to receive it. The verification process is challenging and rigorous as the FDA only approves 15 percent of the applications annually.
Bifidobacterium bifidum BGN4, isolated from healthy baby's feces, is one of the many bacterial strains that occur naturally in the gut flora, living in the colon. The primary functions of this substance are biotransformation activity of phytochemicals, high intestinal adhesion activity due to cell surface hydrophobicity, direct and indirect immunoregulatory activity.
“The approval proves that BGN4 has satisfied the strict conditions of the FDA's screening requirements,” the company said.
With such superb characteristics, the company is exporting raw materials and finished products of BGN4 to 25 countries, including China, Taiwan, Hong Kong, Germany and New Zealand.
“The company is pleased to have been officially acknowledged for its 30-years of microbiological research through the FDA’s NDI,” a company official said. “BGN4, Bifido’s key strain, is recognized in overseas markets as the company’s overseas sales are 1.7 times larger than domestic sales.”
The company will accelerate its entry into the global microbiome market, including the U.S. and Europe, with its core strains, he added.