What are the Prohibited Expressions in Supplement Advertisements? Explaining Three Japanese Laws that Require Attention

Supplements, which started as “auxiliary foods” to replenish nutrients that tend to be lacking in daily meals, are now being sold in various forms expressing their functions due to various systems.

However, there has been an increase in cases where expressions in supplement advertisements mislead consumers, and in the worst cases, there are instances where corrective orders and penalties are imposed.

Therefore, in this article, we will organize and explain in detail the unacceptable expressions for supplements that advertisers and advertising-related parties must be aware of.

What are Supplements?

Supplements are not clearly defined by law, but they are generally classified as health foods. However, unlike regular foods, they tend to come in forms similar to pharmaceuticals, such as powders, tablets, and capsules.

Originally, they were primarily health supplements, but now they not only supplement the nutrients necessary for maintaining health, but also include those with specific physiological functions or health functions based on law, or those that are sold with functions displayed based on scientific evidence.

There are various types of supplements, but they can be broadly divided into the following two categories:

• So-called health foods (nutritional supplements, health supplements, nutritional adjustment foods, etc.)

These are foods that do not receive approval from the government and cannot display functionality.

• Health functional foods (Japanese Specific Health Foods, Nutritional Functional Foods, Functional Display Foods)

These are foods that can display functionality based on the “Health Functional Food System” and the “Functional Display Food System”.

Even if it is sold as a food, if it has a therapeutic or preventive effect on diseases, it is considered a pharmaceutical and is distinguished from health foods.

Reference: Consumer Affairs Agency “What is the Food Labeling System for Health and Nutrition?”[ja]

Three Health Foods Capable of Functional Labeling

Health foods are those that can display their functions according to the safety and efficacy standards set by the government. Unlike pharmaceuticals, they are not intended for the treatment or prevention of diseases.

Japanese Foods for Specified Health Uses (FOSHU)

Foods for Specified Health Uses, or FOSHU, are foods that contain ‘functional ingredients’ that affect physiological functions of the body. They have undergone a review by the Consumer Affairs Agency for their efficacy and safety and have been approved. These foods can display ‘specific health functions’ along with the ‘FOSHU mark’.

‘Functional ingredients’ include oligosaccharides, lactic acid bacteria, dietary fibers, etc., and ingredients that are only approved for pharmaceuticals cannot be used.

The approved functional displays vary depending on the type of functional ingredient, but they include ‘helps maintain normal blood sugar, blood pressure, and cholesterol levels’, ‘helps regulate the condition of the stomach’, and ‘helps maintain bone health’.

Japanese Nutrient Function Foods

Nutrient Function Foods are foods intended to supplement specific nutrients necessary for maintaining human life and health. If they meet the standards set by the government, they can display the functions of the nutrients contained in the food and sell them without applying for permission or notification.

Currently, the standard nutrients include the following vitamins and minerals, as well as specific fatty acids.

• Vitamins

Niacin, Pantothenic Acid, Biotin, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Folic Acid

• Minerals

Zinc, Potassium, Calcium, Iron, Copper, Magnesium

Japanese Foods with Function Claims

Foods with Function Claims are those that have evaluated the scientific evidence and safety of health functions based on the rules set by the government and have notified the Consumer Affairs Agency. No review or approval by the Consumer Affairs Agency is required.

Also, the information reported is made public on the Consumer Affairs Agency’s website, so anyone can check the content.

The functional evaluation is conducted by one of the following methods:

• Conducting clinical trials using the final product

In this case, the expression of functionality is ‘has the function of ○○’.

• Conducting a literature survey on the final product or functional ingredient

In this case, the expression of functionality is ‘it has been reported to have the function of ○○’.

Three Laws Pertaining to Supplement Advertising

Advertisers and those involved in advertising supplements must be aware of three important laws: the ‘Japanese Pharmaceuticals and Medical Devices Act’, the ‘Japanese Health Promotion Act’, and the ‘Japanese Act against Unjustifiable Premiums and Misleading Representations’.

Japanese Pharmaceuticals and Medical Devices Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices)

The products regulated by the Pharmaceuticals and Medical Devices Act are ‘pharmaceuticals’, ‘quasi-drugs’, ‘cosmetics’, ‘medical devices’, and ‘regenerative medicine products’. Although supplements are not directly related to these, if an advertisement for a supplement expresses effects or efficacy similar to pharmaceuticals or quasi-drugs, it will be in violation of the Pharmaceuticals and Medical Devices Act.

Japanese Health Promotion Act

The provision that must be noted in the Health Promotion Act is Article 65, Paragraph 1, which pertains to exaggerated claims.

Article 65 (Prohibition of Exaggerated Claims)

1. No person shall make a representation in an advertisement or otherwise concerning a product offered for sale as food that significantly deviates from the facts or is likely to significantly mislead people with respect to matters concerning the maintenance and promotion of health and other matters prescribed by Cabinet Office Ordinance (referred to as “effects for maintaining and promoting health, etc.” in paragraph 3 of the following article).

This provision regulates representations in advertisements for ‘products offered for sale as food’, so it applies not only to ‘so-called health foods’ but also to supplements sold as ‘foods with health claims’.

Furthermore, as it is stipulated as ‘no person’, not only manufacturers and sellers of the product, but also advertising agencies and service providers who handle advertisements are subject to this provision, so caution is required.

Japanese Act against Unjustifiable Premiums and Misleading Representations

With regard to supplement advertising, what needs to be noted in the Act against Unjustifiable Premiums and Misleading Representations are the ‘misleading superior quality representations’ and ‘misleading favorable representations’ prohibited in Article 5.

Misleading superior quality representation is an act of misleading general consumers by making representations such as ‘significantly superior to the actual product’ or ‘significantly superior to similar products of other businesses’ about the products they supply, in order to attract customers unfairly.

Misleading favorable representation is an act of misleading general consumers by making representations such as ‘significantly more advantageous to the other party than the actual product’ or ‘significantly more advantageous to the other party than other businesses’ about the products, services, prices, and other transaction conditions they supply, in order to attract customers unfairly.

Types of Prohibited Expressions in Supplement Advertisements

Common Prohibited Expressions

The following expressions, which may be mistaken for the efficacy and effects of pharmaceuticals, disease names, and pharmaceuticals as defined by the Japanese Pharmaceutical Affairs Law, are universally prohibited for all supplements.

Efficacy and effects aimed at treating or preventing diseases

Prohibited expressions: For people with diabetes, hypertension, arteriosclerosis, prevention of gastric and duodenal ulcers, curing liver and kidney disorders, improving cancer, for people with eye diseases, curing constipation, etc.

Efficacy and effects aimed at generally enhancing or promoting bodily tissue functions

Prohibited expressions: Fatigue recovery, virility enhancement, physical strength enhancement, appetite promotion, anti-aging, improving learning ability, rejuvenation, revitalization, boosting energy, promoting metabolism, enhancing endocrine function, enhancing detoxification function, enhancing heart function, purifying blood, increasing natural healing ability against diseases, enhancing digestion and absorption of the gastrointestinal tract, promoting stomach health and regulating intestines, promoting growth during and after illness, etc. (Expressions related to nutritional supplementation and health maintenance do not fall under this efficacy and effect)

Implication of pharmaceutical-like efficacy and effects

• Implications through names or catchphrases

Prohibited expressions: Life-extending ○○, Essence of ○○ (source of immortality), Essence of ○○ (source of eternal youth), Medicine ○○, Eternal youth and longevity, Essence of longevity, Secret Chinese medicine, Imperial Chinese prescription, Japanese and Chinese traditional prescription, etc.

• Implications through the display and explanation of ingredients

Prohibited expressions: Improving constitution, known for promoting stomach health and regulating intestines, using ○○○○ as a raw material, adding useful ingredients to it, having a synergistic effect, etc.

• Implications through the explanation of manufacturing methods

Prohibited expressions: It is made by preparing the plant ○○○, which grows naturally in the deep mountains and highlands of Japan, as the main ingredient, and △△△, ×××, etc. of medicinal herbs by a unique manufacturing method (patent application for manufacturing method), etc.

• Implications through the explanation of origin, derivation, etc.

Prohibited expressions: If you look at the old natural science book called ○○○, it says that it opens the stomach, disperses depression, helps digestion, kills worms, and eliminates phlegm, etc. It was always prepared for meals because such experiences have been passed down from ancient times, etc.

• Implications through the citation or posting of articles from newspapers, magazines, etc., talks, theories, and experiences of doctors, scholars, etc.

Prohibited expressions: Talk of Dr. ○○○○, a medical doctor

“It has been said from ancient times that if you sprinkle △△△ on red rice and eat it, you will not get cancer. … It is thought that there may be a connection between the abnormal lipid metabolism of cancer cells, and subsequently abnormal carbohydrate and protein metabolism, and △△△.” etc.

Prohibited Expressions for Foods for Specified Health Uses (FOSHU)

Foods for Specified Health Uses (FOSHU) are foods that are permitted by the Consumer Affairs Agency of Japan to display “specific health functions”. However, expressions that exceed the permitted content or differ from the facts may potentially fall under “false and exaggerated representation”.

Expressions that exceed the permitted content

Permitted content: “This supplement contains ○○, which helps suppress the rise in blood triglycerides after meals, and is useful for improving the dietary habits of people who tend to eat high-fat meals.”

Prohibited expressions: “Reduces body fat”, “Suppresses the rise in triglycerides”

Permitted content: “This supplement contains ○○, which has the effect of inhibiting the absorption of cholesterol, making it a suitable food for those who are concerned about cholesterol.”

Prohibited expression: “Inhibits the absorption of cholesterol”

Permitted content: “This supplement contains ○○, which gently absorbs sugar, making it suitable for those who are starting to worry about their blood sugar levels.”

Prohibited expression: “Lowers blood sugar levels”

Improper use of surveys and monitor studies

Question: “Are you satisfied with your purchase of this product?”

Prohibited expression: “○○% of people felt the effect” (The question is not about the effect)

Survey results: There were a considerable number of testimonials that they could not feel the effect of the product.

Prohibited expression: “Anyone can easily expect the same effect” (Quoting only convenient testimonials)

Expressions that suggest that diseases can be cured without a doctor’s diagnosis or treatment

Prohibited expressions: “If you take this product, you can cure cancer without going to the doctor!” “Just drink one of this product a day to improve diabetes without relying on dietary therapy or medication!”

Prohibited Expressions for Nutritional Functional Foods

Nutritional functional foods are foods that can display the functions of the nutrients they contain. However, there is a possibility of falling under “false and exaggerated representation” if functions are displayed for ingredients other than the nutrients defined by the government or for intake amounts that do not meet the standards.

Function display for ingredients other than the nutrients defined by the government

Applicable case: A case of a supplement containing amino acids different from the nutrients defined by the government

Prohibited expression: “Amino acids are nutrients that promote fat burning.”

Function display for nutrients that do not meet the intake amount defined by the government

Applicable case: A case where the amount of calcium included in the daily recommended intake of a supplement needs to be 204mg or more to display the function of calcium, but it was 100mg

Prohibited expression: “Calcium is a nutrient necessary for the formation of bones and teeth.”

Prohibited Expressions for Foods with Function Claims

Foods with function claims can be labeled as such if they are evaluated based on the rules set by the Japanese government and reported to the Consumer Affairs Agency. However, there is a possibility of falling under “false and exaggerated representation” if expressions exceeding the reported content or expressions that could be misunderstood as having obtained government approval are used.

Expressions Exceeding the Content Reported to the Consumer Affairs Agency

Reported expression: “This supplement contains ○○ (name of the functional ingredient). It has been reported that ○○ has the function of lowering cholesterol in the blood.”

Prohibited expression: “Lowers cholesterol”

Reported expression: The only functional ingredient reported is “indigestible dextrin”

Prohibited expression: “Contains indigestible dextrin and soy isoflavones, which help reduce visceral fat.” (※Soy isoflavones are not a functional ingredient)

Expressions that Could be Misunderstood as Foods for Specified Health Uses by Consumers

Prohibited expression: Anything that could be mistaken for a food for specified health use, such as making the “product name”, “design”, “ingredients”, “catchphrase”, etc. similar to existing foods that are well recognized by consumers as foods for specified health use.

Expressions that Could be Misunderstood as Having Received Evaluation/Approval from the Government by Consumers

Prohibited expression: “Approved by the Consumer Affairs Agency”, “Authorized by the Commissioner of the Consumer Affairs Agency”, “Approved by the ○○ Ministry”, “Recommended by the ○○ Ministry”, “Confirmed by the ○○ Ministry”, “Also recognized by the ○○ government agency”, etc.

When the Scientific Evidence Backing the Representation Lacks Rationality

Reported material: Intentionally extracting only positive papers from the research review on functionality

Prohibited expression: “This product contains ○○ (name of the functional ingredient). It has been reported that ○○ has the function of ○○.”

Reported material: Partial function based on evidence obtained using data from limited indicators

Prohibited expression: “Maintains the health of specific parts of the body (eyes, joints, brain, etc.)” etc. (※Indicating effectiveness for many parts)  

Conclusion: Legal Checks for Supplement Advertisements

In this article, we have discussed problematic expressions often found in supplement advertisements, including “commonly unacceptable expressions” and “category-specific unacceptable expressions”, based on notifications and guidelines from the Ministry of Health, Labour and Welfare and the Consumer Affairs Agency.

Violations of various laws can result in severe penalties, including fines and imprisonment. For example, those who violate the Japanese Act against Unjustifiable Premiums and Misleading Representations and do not comply with the orders may face imprisonment for up to two years or a fine of up to 3 million yen, or both. Businesses can be fined up to 300 million yen, and representatives who do not take appropriate measures can be fined up to 3 million yen.

In addition to the “Pharmaceuticals and Medical Devices Act” (Japanese Pharmaceuticals and Medical Devices Act), “Health Promotion Act” (Japanese Health Promotion Act), and “Act against Unjustifiable Premiums and Misleading Representations” (Japanese Act against Unjustifiable Premiums and Misleading Representations) introduced in this article, there are other related laws and various guidelines for supplement advertisements. Therefore, when actually advertising supplements, we recommend that you receive a legal check from a lawyer with specialized knowledge and extensive experience, rather than making judgments on your own.

If you want to know more about the points to note in advertising expressions for cosmetics and health foods, please see the following article.

Related article: Points to Note in Advertising Expressions for Cosmetics and Health Foods[ja]

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