[2026 Latest] The Legal Definition of Supplements Is Finally Moving Forward – Consumer Affairs Agency's Regulatory Policy and What You Need to Know Before Creating Products with OEM

Introduction

In April 2026, news emerged from Japan's supplement industry that the Consumer Affairs Agency's "New Foodstuffs Research Committee of the Food Sanitation Standards Council" indicated a specific direction regarding the legal definition of supplements and the scope of GMP (Good Manufacturing Practice) application.

What is the legal definition of a supplement? What is GMP? Is there any relationship to our OEM?

This is a news commentary article that we strongly recommend to those who feel that way. It contains information that clinic and salon owners who are considering developing their own brands through NMN supplement OEM will not regret knowing.

Why is the "definition of supplements" an issue now?

Actually, Japan has not had a legal definition of "supplement" until now.

There was a system for "Foods with Health Claims," such as Foods with Function Claims and Foods for Specified Health Uses (Tokkuhou). However, for the "so-called health foods and supplements other than these," which make up the majority of the market, there was no legal definition or mandatory manufacturing standards.

The United States, EU, South Korea, China, and Canada – almost all major countries legally define supplements and operate them in conjunction with Good Manufacturing Practice (GMP). Japan alone has long postponed this development.

What happened there was,Kobayashi Pharmaceutical's "Red Yeast Rice Supplement" issue in March 2024is.

A large number of kidney disorders have occurred in individuals taking the "Benikoji Cholesterol Help" functional food, with reports of suspected deaths and hospitalizations. It is presumed that the cause was the contamination of blue mold in the factory that manufactured the raw material, leading to the production of harmful substances.

The problem here was,The factory that produced the final product met GMP standards, but the factory that produced the raw materials did not have GMP certification.is a fact.

This incident prompted the country to begin seriously developing regulations for all supplements.

The contents of the "draft definition" presented in April 2026

At the April 23, 2026 meeting of the Consumer Affairs Agency's New Food Development Survey Subcommittee, the following direction was presented as a draft definition for supplements:

"Foods intended to supplement nutrient intake or regulate physiological functions with ordinary meals," which are concentrated in ingredients, are in easy-to-take forms such as tablets, capsules, liquids, or powders, and may pose a risk of excessive intake.

There are three key points.

The "objective" has been clearly defined.
A distinction was made between foods that are simply "good for health" and those intended for "nutritional supplementation" or "assisting in the regulation of physiological functions."

Judged by "shape"
A requirement for supplements is that they come in easy-to-take forms, such as tablets, capsules, powders, or liquids, which differ from regular meals.

③ "Risk of excessive intake" is also considered
Unlike regular foods, whether there is a risk of overconsumption is also included as a criterion.

Additionally, it is reported that "foods with recognizable flavors" such as gummies and jellies will be excluded from mandatory requirements for the time being. However, there are dissenting opinions within the committee, and this may change depending on future discussions.

"What does 'GMP mandatory, raw materials excluded' mean?"

Another major point of contention this time was,Scope of mandatory GMPis.

GMP refers to manufacturing control standards that stably ensure product quality and safety. A third-party organization inspects and certifies whether these standards, concerning "what equipment to use," "what procedures to follow," and "how to record during manufacturing," are met.

The direction shown this time is as follows.

• Finished product manufacturing plantMandatory GMP compliance (including imported goods)
• Raw material manufacturing plant→ Not applicable to GMP (handled by food safety management standards such as HACCP and existing voluntary inspection guidelines)

The main reason for excluding raw materials was that "natural raw materials such as those derived from plants and seafood have diverse manufacturing processes, making it realistically difficult to universally impose GMP." The same framework is adopted in the United States, and this decision was made with international consistency in mind.

However, even though the fundamental cause of the red yeast rice problem was precisely "inadequate management at the raw material factory," some committee members expressed doubts, asking "Is that really okay?" that raw materials were excluded from the scope. This point requires continued attention.

Future schedule

The flow of events as currently understood is approximately as follows.

In other words,In the next two to three years, the manufacturing control standards for supplements sold domestically will change significantly.It is highly likely.

To those considering OEM for NMN supplements

So, what does this news mean for clinics and salons that are thinking about creating OEM NMN supplements?

Please be sure to check the quality control of raw materials as well.

As this discussion shows, even if the final product is GMP compliant, safety is not guaranteed if the quality control of raw materials is insufficient.

The ingredient NMN, in particular, has significant variations in purity and quality, making it essential to verify the origin of the raw materials and their Certificate of Analysis (CoA). At Zaaz, we focus on quality from the raw material selection stage and only deal with reliable suppliers.

Stricter regulations are also a tailwind for "trusted brands."

You might feel anxious hearing about stricter regulations, but they are in place to protect consumers. And at the same time,A market where brands that are serious about quality are justly recognized.Therefore, that is also the case.

If you're entering the supplement market now, aligning yourself with regulatory trends and approaching the business with a commitment to "creating trustworthy products" will lead to long-term brand value.

Summary

To summarize the latest news, it is as follows:

• The term "supplement," which lacked a legal definition in Japan for many years, is finally moving towards being legally defined.
• GMP (Good Manufacturing Practice) is expected to be mandated for final product factories. Raw material factories will be exempt for the time being.
• Confectionery shapes like gummies and jellies will be excluded for the time being, but this may change in the future.
• Expected to be implemented around 2027-2028.
• For businesses considering OEM, selecting a GMP-certified factory is no longer just an option, but a necessity.

The regulatory environment for supplements is at a major turning point. Choosing a reliable OEM partner has become more important than ever.

Please feel free to contact us anytime for consultations or quotes regarding NMN supplement OEM.

*The information in this article is as of May 2026. Laws and regulations are subject to change in the future. For the latest information, please refer to the official information from the Consumer Affairs Agency and the Ministry of Health, Labour and Welfare.