Regulations, Research

OptiMSM Recognized as a Food with Functional Claims (FFC) in Japan

The approval also allows companies using OptiMSM in their formulations to now feature joint health-related claims on product packaging.

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By: Sean Moloughney

Editor, Nutraceuticals World

Balchem’s brand of methylsulfonylmethane (MSM), OptiMSM (which the company acquired from Bergstrom in 2022), has been granted Food with Functional Claims (FFC) approval by the Japanese Consumer Affairs Agency.

This milestone was driven by a recent study confirming the ingredient’s role in supporting joint health. It marks the first recognition of MSM under this category in Japan and underscores its proven safety, efficacy and reliability, Balchem said.

The approval also allows companies using OptiMSM in their formulations to now feature joint health-related claims on product packaging.

“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,” said Jessica Arnaly, senior marketing and business development manager, Human Nutrition & Health. “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 U.S. Now, with its recognition under Japan’s Food with Functional Claims, we further solidify its role in supporting mobility, as well as its leading quality, reliability, and strong scientific background.”

Evidence-Based Claims System

The Foods with Functional Claims system enables brands to label foods or supplements with scientifically supported health benefits, grounded in evidence from systematic literature reviews or clinical trials.

OptiMSM approval was based on a study showing the potential of oral MSM intake at a dose of 2 grams/day in improving overall joint health and comfort in individuals experiencing mild pain in knee joints. The randomized, double-blind, placebo-controlled trial evaluated 88 healthy adults consuming either 2 grams of OptiMSM or a placebo for 12 weeks. Using the Japanese Knee Osteoarthritis Measure (JKOM), the study demonstrated that participants taking OptiMSM saw improvements in pain levels, especially in the morning and while standing.  

“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,” said Arnaly. “MSM is already widely used in dietary supplements 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.”

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