Global supplement regulation: increasing scrutiny across key markets

Japan moves towards stronger GMP requirements

Following the Kobayashi red yeast rice incident, linked to contaminated red yeast rice supplements, Japan is considering significant reforms to its supplement framework.

On June 19, 2026, the Consumer Affairs Agency published an interim report proposing a clearer definition of supplements, alongside mandatory Good Manufacturing Practice (GMP) requirements for products sold as tablets, capsules, powders and liquids.

The proposals also include strengthened oversight of manufacturing quality, product safety and risk management across the supply chain. Further government deliberations and potential regulatory measures are expected through late 2026 and into 2027.

EU continues focus on vitamins and minerals

In the EU, attention remains focused on the development of harmonised maximum and minimum levels for vitamins and minerals in food supplements.

Germany’s Federal Institute for Risk Assessment (BfR) has emerged as a key reference point. Several Member States view its risk-based thresholds as a potential model for future EU-wide limits. A public consultation is expected in the third quarter of 2026, with adoption of harmonised levels currently anticipated around 2028.

US reassesses safety pathways for novel dietary ingredients

In the US, regulators are reassessing the dietary supplement framework to ensure it remains fit for purpose in a rapidly evolving market.

Following a US Food and Drug Administration (FDA) public meeting in March 2026, discussions have focused on how novel dietary ingredients should be evaluated and regulated, including whether existing safety assessment and notification pathways remain appropriate for emerging innovations.

Although the next steps remain unclear, the initiative signals a broader effort to modernise the regulatory framework and strengthen safety oversight. Businesses developing innovative ingredients should monitor these discussions closely, as future changes could affect safety assessment requirements, regulatory submissions and routes to market.

Different approaches, shared direction

While the regulatory developments emerging in Japan, the EU and the US differ in their specifics, they point to a broader trend towards greater scrutiny of supplement safety, manufacturing quality and substantiation. Businesses that identify and respond to emerging requirements early will be better placed to maintain market access, reduce compliance risk and make informed product development decisions.

Understanding how these developments could affect products, portfolios and market strategies is becoming increasingly important for businesses operating internationally. Through our global regulatory consulting services and membership programme. Leatherhead Food Research helps organisations stay informed, assess regulatory risk and navigate evolving compliance requirements with confidence.