Frombio (CEO Shim Tae-jin) announced on the 13th that it has been finally selected as a recipient of the '2026 Food Enterprise Overseas Certification Support Project' organized by the Korea Food Industry Cluster Promotion Agency under the Ministry of Agriculture, Food and Rural Affairs.
Through this project, Frombio aims to obtain U.S. FDA NDI (New Dietary Ingredient) certification for its self-developed ingredient, 'Mastic Gum Complex (FHH-MG).' NDI certification is a system that requires the pre-evaluation and reporting of the safety of new functional food ingredients in the U.S., and it is an essential procedure for distribution in the U.S. market. This ingredient has currently been submitted to the Korean Ministry of Food and Drug Safety as an individually recognized ingredient for 'hair health' functionality.
Frombio was finally selected for the NDI certification sector on February 12, signed an agreement on March 12, and began full-scale operations. The project is being carried out jointly with the Korea Testing & Research Institute (KTR), a cooperating agency for overseas certification support, and 70% of the total project cost has been secured through government funding.
The company plans to implement a 'two-track' strategy of simultaneously securing approval from the Korean Ministry of Food and Drug Safety and the U.S. FDA by obtaining NDI certification. Upon completion of certification, it intends to proceed in stages, starting with B2B raw material supply to the U.S. and launching B2C products through global platforms such as Amazon, based on verified safety.
Frombio plans to focus on preparing technical documentation that meets FDA regulatory requirements and securing safety data, with the goal of completing NDI certification by December 2026. Furthermore, based on this certification, the company intends to advance its internal standard system to facilitate future overseas certifications for additional functional ingredients.
Hong In-ki, Head of Research at Frombio, stated, “The selection for this national project objectively verifies the excellence of our functional ingredients and our global competitiveness,” adding, “We will achieve U.S. NDI certification through thorough preparation and lay the foundation to promote K-health functional food technology to the global market.”
Frombio is an R&D-focused company possessing KFDA-approved raw materials such as Boswellia extract and mastic gum, and is recently expanding its business into the bio sector, including hair loss alleviation and stem cell research.
Recently, there has been an increasing number of cases in the health functional food industry where companies are strengthening their entry into global markets by leveraging overseas regulatory certifications, including the U.S. FDA NDI certification.
- See more related articles
You must be logged in to post a comment.