Balchem’s OptiMSM becomes first MSM ingredient approved under Japan’s FFC system

Balchem has achieved a regulatory milestone in Japan with its methylsulfonylmethane (MSM) OptiMSM offering. The ingredient was approved under Japan’s Food with Functional Claims (FFC) system — the first time a MSM ingredient has earned this designation in the country.

According to Balchem, the approval by Japan’s Consumer Affairs Agency allows supplement and functional food brands using OptiMSM in their formulations to legally promote joint health benefits on packaging and marks a “significant step forward” for MSM-based products in one of the world’s most competitive and compliance-driven health markets.

“As a source of sulfur, MSM is a critical component in the building blocks of joints and connective tissues, providing cartilage with much-needed nutrients and helping maintain joint comfort,” says Jessica Arnaly, the senior marketing and business development manager for human nutrition and health at Balchem.

“With a long-standing reputation in the joint health space, Balchem’s OptiMSM already stands out as the only form of MSM to have received a GRAS (Generally Recognized As Safe) letter of non-objection in the US.”

“Now, with its recognition under Japan’s FCC, we further solidify its role in supporting mobility, as well as its leading quality, reliability, and strong scientific background.”

Science-backed joint health benefits

Balchem highlights that the approval was granted following a randomized, double-blind, placebo-controlled trial involving 88 healthy adults experiencing mild knee pain. Participants received either 2,000 mg of OptiMSM or a placebo daily over a 12-week period.

Results, measured by the Japanese Knee Osteoarthritis Measure, showed significant improvements in joint comfort among those taking OptiMSM, particularly in morning stiffness and pain during standing.

At the same time, Balchem spotlights that its proprietary multi-stage distillation process used in the purification of the ingredient removes contaminants such as heavy metals — an advantage it says has helped set it apart in global markets.

“Joint health is a key focus in Japan’s functional food and drink market, with growing product innovation aimed at both seniors and younger consumers, and an emphasis on nutritional solutions to support mobility and healthy aging,” Arnaly underscores. “MSM is already widely used in dietary supplement brands in Japan.”

“With this approval, OptiMSM can now support our Japanese consumers, allowing for clear on-pack claims while also providing greater assurance about the health benefits of MSM-containing products.”

Commercial implications for supplement brands

Balchem emphasizes that, with joint discomfort affecting a large segment of Japan’s older population, and MSM gaining traction as a clinically supported, non-pharmaceutical option, the FFC approval positions OptiMSM for ingredient and supplement innovation.

As a result of the approval, Balchem says its partners can now move faster in launching products in Japan that highlight the joint health benefits of OptiMSM, while using approved health claims backed by clinical evidence.