Health Foods and the PMD Act in Japan

What Are Health Foods?

Health foods generally refer to foods consumed with the expectation of maintaining or improving health, supplementing nutrition, supporting beauty, or managing daily physical condition.

Typical examples include dietary supplements, nutritional supplements, protein products, vitamins, minerals, amino acids, lactic acid bacteria products, herbal products, plant extracts and other wellness-related foods.

In Japan, “health food” is not a single formal legal category under the PMD Act. The regulatory position depends on the product’s ingredients, intended use, labelling, advertising claims, sales route and how the product is presented to consumers.

Why This Matters in Import Practice

Health foods may be importable as foods under the food safety framework. However, that does not mean that the product can be freely sold with health, disease-related or body-function claims in Japan.

If the label, website, advertisement or sales explanation suggests that the product can diagnose, treat, cure or prevent disease, or strongly affect bodily functions, the product may be regarded as making pharmaceutical-like claims.

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly called the PMD Act, is relevant when a product is presented with pharmaceutical-like effects or uses.

For importers, overseas suppliers and origin-side forwarders, the key point is to separate physical import as food from domestic sale, labelling and advertising compliance in Japan.

Typical Products

Products imported or sold as health foods may appear in many forms, including tablets, capsules, powders, liquids, beverages, processed foods and packaged supplements.

• Vitamin, mineral and amino acid supplements
• Protein powders and sports nutrition products
• Enzyme products, probiotics and green juice products
• Beauty, diet, fatigue-related or wellness-positioned foods
• Foods containing herbs, plant extracts or animal-derived ingredients
• Products related to Food with Health Claims, Food with Functional Claims, Nutritional Function Foods or Foods for Specified Health Uses (FOSHU)

The product form alone does not decide the regulatory treatment. A capsule or tablet may still be a food, while an ordinary-looking food may become problematic if the claims or ingredients suggest pharmaceutical use.

Food Status and Pharmaceutical-Like Claims

Health foods are generally handled as foods when they are intended for ordinary consumption and do not make pharmaceutical-like claims.

However, foods cannot normally claim to diagnose, treat, cure or prevent diseases. Expressions such as “cures hypertension,” “prevents cancer,” “effective for diabetes,” or “prevents infectious disease by enhancing immunity” may create serious regulatory concerns.

Even indirect expressions may be problematic if the overall presentation implies a pharmaceutical effect. Testimonials, rankings, expert comments, research data, before-and-after images, social media posts and e-commerce descriptions should therefore be reviewed together.

Some products may also fall under the quasi-drug category, which is regulated separately from ordinary foods and pharmaceutical products in Japan. Quasi-drugs require separate regulatory treatment and should not be confused with ordinary health foods.

Food with Health Claims

Japan has specific systems for certain foods that may carry health-related claims, such as Foods for Specified Health Uses (FOSHU), Nutritional Function Foods and Food with Functional Claims.

These systems are different from ordinary health food marketing. They require specific conditions, wording, evidence, notification or approval procedures depending on the category.

Importers should not assume that a product sold overseas as a supplement or functional food can use the same claims in Japan. The Japanese claim category and permitted wording must be checked separately.

Ingredients and Restricted Substances

Health foods may also raise issues because of their ingredients.

Some ingredients that are used in supplements overseas may be treated differently in Japan. They may be regarded as pharmaceutical ingredients, restricted substances, food additives, novel ingredients, animal-derived materials or ingredients requiring special safety confirmation.

Importers should check not only the finished product label, but also the ingredient list, botanical names, extract ratios, active components, manufacturing process and country-specific regulatory status.

Import and Sale Requirements

When health foods are imported for business sale in Japan, several laws may be relevant at the same time.

The Food Sanitation Act may require food import notification and, depending on the product, inspection or confirmation of additives, residues, contaminants, raw materials and manufacturing conditions.

The Food Labeling Act is relevant to Japanese food labels, nutrition information, allergen information, origin information and permitted health-related claims.

The PMD Act becomes important when the product, label or advertising suggests pharmaceutical-like efficacy, disease treatment, disease prevention or strong effects on body functions.

Some products may need to be checked as quasi-drugs rather than ordinary health foods. This may be relevant for products positioned close to beauty, oral care, hair growth, medicated hygiene or certain body-function claims.

Other rules, such as the Act against Unjustifiable Premiums and Misleading Representations, are also important where advertising gives consumers a misleading or exaggerated impression.

Labelling and Advertising

For health foods, the wording used in labels and advertisements is often more important than the product name itself.

Importers should review Japanese package labels, product inserts, e-commerce pages, brochures, videos, social media posts, affiliate articles, influencer content and customer testimonials.

Statements about disease names, improvement, prevention, immunity, blood pressure, blood glucose, hormones, sleep, fatigue, weight loss, detox effects or anti-aging effects should be checked carefully.

The Act against Unjustifiable Premiums and Misleading Representations should also be considered. Even where a claim does not directly create a PMD Act issue, exaggerated performance claims, misleading rankings, unsupported comparative claims or overly strong consumer testimonials may create advertising law problems.

Overseas package wording and website descriptions should not be translated directly into Japanese without legal and regulatory review.

Personal Import and Business Import

Health foods may sometimes be imported personally by individuals for their own use. This should be separated from business import and domestic resale.

A product imported for personal use cannot simply be resold in Japan as a business product. Once the product is sold, distributed or advertised in Japan, the importer must consider food safety, labelling, advertising and PMD Act issues.

Forwarders and overseas sellers should be especially careful when a shipment that appears to be personal import is actually connected with online resale, marketplace sale or commercial distribution.

Main Points to Check

When handling health foods for shipment to Japan, forwarders and import coordinators should check the following points with the importer:

• Whether the product is imported as food, medicine, quasi-drug or another regulated product
• Whether the ingredients include pharmaceutical or restricted substances in Japan
• Whether the product requires food import notification or inspection
• Whether the Japanese label is prepared under the Food Labeling Act
• Whether the product makes disease-related or pharmaceutical-like claims
• Whether overseas advertising claims will be used in Japan
• Whether advertising claims may create misleading representation issues
• Whether the product is for personal use or business sale
• Whether the importer has confirmed the applicable health claim category, if any
• Whether documentary evidence is retained if the importer concludes that the product is not a pharmaceutical product or quasi-drug

Common Problems

• The invoice only says “supplement,” “health food” or “nutrition product”
• The importer checks food import requirements but ignores PMD Act claim issues
• The overseas product page contains disease-related claims
• The Japanese sales page uses expressions such as “cure,” “improve,” “prevent” or “effective for”
• The product may fall under the quasi-drug category, but it is treated as ordinary health food
• The product contains an ingredient treated as pharmaceutical in Japan
• A product imported for personal use is later sold online
• Testimonials or influencer posts imply pharmaceutical effects
• Advertising claims may be treated as misleading or exaggerated representations
• The importer does not retain evidence for a “not pharmaceutical” conclusion

Practical Notes for Shipments to Japan

For shipments to Japan, origin-side forwarders should be cautious when cargo descriptions include terms such as “supplement,” “health food,” “diet product,” “nutrition product,” “herbal extract,” “capsule,” “tablet,” “functional food” or “wellness product.”

These terms do not automatically mean that the shipment is prohibited. However, they are warning signs that the Japanese importer should confirm food import requirements, PMD Act-related claim issues, quasi-drug possibility and advertising law issues.

In Japanese practice, the formal import process and the domestic sales expression should be separated clearly. A product may clear as food, but still create problems if it is sold with pharmaceutical-like or misleading claims.

Relationship with Logistics and Customs

Forwarders and customs brokers are not expected to decide all food law or PMD Act classifications by themselves.

However, they should notice when a product description suggests possible supplement, health food, pharmaceutical ingredient, quasi-drug category or disease-related use, and ask the importer to confirm the regulatory position.

If the product includes animal-derived ingredients, plant extracts, powders, liquids, alcohol, capsules, temperature-sensitive materials or restricted ingredients, separate logistics and import compliance checks may also be necessary.

Key Takeaway

Health foods in Japan should be checked from two directions: food import compliance and PMD Act-related claim control.

Quasi-drug classification and advertising law issues should also be considered where the product is close to beauty, hygiene, body-function or strong performance claims.

Even if a product can be imported as food, its ingredients, labels, advertisements and sales explanations may create pharmaceutical or misleading representation issues.

For forwarders and overseas suppliers, the safest approach is to identify supplement and health food cargo early and ask the Japanese importer to confirm the ingredient status, food import requirements, claim wording and advertising compliance before shipment arrangement.