The Korean Ministry of Food and Drug Safety (MFDS) has approved of NXT USA’s TamaFlex, a botanical ingredient formulated for joint health, as a Health Functional Food Ingredient (HFFI), allowing it to be marketed in Korean products.

“We are thrilled to have TamaFlex registered as an HFFI ingredient in Korea,” said David Woo, Korea director of sales at NXT USA. “This approval places TamaFlex in an elite category of natural ingredients that are validated for their specific health benefits, enabling consumers to trust in its proven efficacy. The MFDS has stringent requirements for claims validation, and our three double-blind, placebo-controlled, peer-reviewed, and published clinical studies provide robust support for our claims."

KolmarBNH, a research company selected by the South Korean Ministry of Science, ICT, and Future Planning, has partnered with NXT USA to achieve regulatory approval of the ingredient, and will drive the development of TamaFlex in Korea.

“This is the first of several HFFI registrations for NXT USA. We foresee additional registrations soon as we continue to expand our presence in Korea, a key growth market for us,” Woo said.

The HFFI registration process is a regulatory framework established by the MFDS to ensure safety, efficacy, and quality of functional food ingredients marketed in South Korea. To achieve HFFI registration, ingredients must undergo an evaluation of scientific evidence supporting its health claims. This includes reviews of clinical studies, peer-reviewed research, and other relevant data on health and safety.

Achieving HFFI registration through Korea’s high regulatory standards underscores the credibility and effectiveness of TamaFlex, NXT USA reported.

In three human studies involving over 300 participants, TamaFlex was found to have a beneficial effect on measures of joint health at a daily dosage of 250 mg. The results were based on patient self-reporting, physician assessments, physical performance measures like walking and stair climbing, and biomarkers.