Is There a Legal Obligation to Display the Expiry Date on Quasi-Drugs? A Lawyer Explains

Some of the nutritional drinks, vitamin tablets, and insecticides sold at drugstores and convenience stores fall under the category of “Japanese Quasi-Drugs”.

When a product is classified as a Japanese Quasi-Drug, the strict regulations of pharmaceuticals are relaxed, which is why various companies are entering the manufacturing and sales of Japanese Quasi-Drugs.

However, it is important to note that even for Japanese Quasi-Drugs, there is an obligation to display certain information as stipulated by the Japanese Pharmaceuticals and Medical Devices Act.

So, what kind of information is required to be displayed on Japanese Quasi-Drugs?

In this article, we will explain in detail the display obligations that you should be aware of when involved in the manufacturing and sales of Japanese Quasi-Drugs.

What are Quasi-Drugs?

Quasi-drugs, or “Japanese quasi-drugs,” are products that do not exert a strong effect on the human body when used correctly, and even in cases of misuse, their effects on the human body are mild.

The Pharmaceuticals and Medical Devices Act, or “Japanese Pharmaceuticals and Medical Devices Act,” is a law that regulates pharmaceuticals and other related products. Its official name is “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”.

Previously, it was called the Pharmaceutical Affairs Law, but the name was changed to the Pharmaceuticals and Medical Devices Act following a legal revision in 2013 (Heisei 25).

The Pharmaceuticals and Medical Devices Act covers three types of products: pharmaceuticals, quasi-drugs, and cosmetics.

Among these, quasi-drugs are characterized by their expanding market size due to their easy accessibility.

Types of Quasi-Drugs

There are three main classifications of quasi-drugs:

1. Products that are not mechanical devices and are intended for the prevention of nausea and other discomforts, bad breath or body odor, heat rash, chafing, hair loss, hair growth or hair removal (Pharmaceuticals and Medical Devices Act Article 2, Paragraph 2, Item 1).
2. Products that are not mechanical devices and are used for the purpose of exterminating rats, flies, mosquitoes, fleas, and other similar organisms for the health of humans or animals (Pharmaceuticals and Medical Devices Act Article 2, Paragraph 2, Item 2).
3. Products used for the purposes specified in Article 2, Paragraph 1, Items 2 or 3 of the Pharmaceuticals and Medical Devices Act, which are designated by the Minister of Health, Labour and Welfare (Pharmaceuticals and Medical Devices Act Article 2, Paragraph 2, Item 3).

For example, breath sprays and hair growth products fall under the quasi-drugs of Article 2, Paragraph 2, Item 1 of the Pharmaceuticals and Medical Devices Act. Insecticides fall under the quasi-drugs of the same Item 2.

Even if they contain Pharmaceuticals

Even if a product is originally defined as a “pharmaceutical” for the purpose of treatment or prevention, it may be classified as a “quasi-drug” if it has a mild effect on the human body and is designated by the Minister of Health, Labour and Welfare based on the provisions of Article 2, Paragraph 2, Item 3 of the Pharmaceuticals and Medical Devices Act.

There are 27 items that become quasi-drugs by the designation of the Minister of Health, Labour and Welfare based on Article 2, Paragraph 2, Item 3 of the Pharmaceuticals and Medical Devices Act (Notification No. 25 of the Ministry of Health, Labour and Welfare, February 6, 2009 (Heisei 21)).

Designated Quasi-Drugs

Among the quasi-drugs designated by the Minister of Health, Labour and Welfare, those designated by the Minister of Health, Labour and Welfare based on the provisions of Article 59, Item 7 of the Pharmaceuticals and Medical Devices Act are called “designated quasi-drugs,” and it is mandatory to display this fact.

There are 21 items of designated quasi-drugs, as follows (Notification No. 28 of the Ministry of Health, Labour and Welfare, February 6, 2009 (Heisei 21)).

1) Products intended solely for the extermination of rats, flies, mosquitoes, fleas, and other similar organisms.
2) The following products:
(1) Products intended to improve stomach discomfort.
(2) Anti-snoring drugs.
(3) Health drugs with calcium as the main active ingredient (excluding those listed in (16)).
(4) Cough suppressants.
(5) Stomachic drugs (excluding those listed in (1) and (21)).
(6) Oral and throat drugs (excluding those listed in (17)).
(7) Contact lens fitting drugs.
(8) Antiseptic disinfectants (excluding those listed in (14)).
(9) Drugs for frostbite and chapped skin (excluding those listed in (20)).
(10) Laxatives.
(11) Digestive drugs (excluding those listed in (21)).
(12) Products intended for nourishment, improvement of weak constitution, and nutritional supplementation.
(13) Health drugs with crude drugs as the main active ingredients.
(14) Products intended for disinfection or protection of scratches, cuts, puncture wounds, scratches, blisters, wound surfaces, etc.
(15) Intestinal regulators (excluding those listed in (21)).
(16) Products intended for supplementation of vitamins or calcium during physical fatigue, middle and old age, etc.
(17) Products intended to improve throat discomfort.
(18) Nasal congestion relief drugs (for external use only).
(19) Health drugs containing vitamins (excluding those listed in (12) and (16)).
(20) Products intended to improve chapped skin, chapped skin, heat rash, chafing, fish eyes, corns, rough hands and feet, dryness, etc.
(21) Among the products listed in (5), (11) or (15), those that fall under two or more.

Notification No. 28 of the Ministry of Health, Labour and Welfare, February 6, 2009 (Heisei 21)

Of the 27 items that become quasi-drugs by the designation of the Minister of Health, Labour and Welfare based on Article 2, Paragraph 2, Item 3 of the Pharmaceuticals and Medical Devices Act, the following 6 items are excluded from the 21 items of designated quasi-drugs.

However, this distinction is important in relation to the obligation to display the types of quasi-drugs, which will be discussed later.

• Cotton products (including paper cotton) intended for sanitary use.
• Hair dyes.
• Disinfectants for soft contact lenses.
• Permanent wave agents.
• Products that are intended for use for purposes other than those specified in Article 2, Paragraph 3 of the Pharmaceuticals and Medical Devices Act, and are also intended for the prevention of acne, rough skin, rash, frostbite, etc., or for the disinfection of skin or oral cavity.
• Bath additives.

Please note that supplements (health foods) that do not fall under quasi-drugs are regulated by the Health Promotion Act, not the Pharmaceuticals and Medical Devices Act.

Display Obligations for Quasi-Drugs

Quasi-drugs are less regulated than pharmaceuticals, and can be sold without obtaining permission from pharmacies or retail businesses.

However, there are various display obligations unique to quasi-drugs.

Expiration Date

For certain quasi-drugs, it is necessary to display the expiration date (Article 59, Paragraph 10 of the Japanese Pharmaceuticals and Medical Devices Act).

The quasi-drugs subject to this are defined as follows by the Ministry of Health, Labour and Welfare Notice No. 116 of 1980 (Showa 55). However, quasi-drugs that remain stable in terms of properties and quality for more than three years under appropriate storage conditions after manufacture or import are not subject to this.

1. Preparations of ascorbic acid, its esters, and their salts
2. Peroxide compounds and their preparations
3. Liver oil and its preparations (limited to quasi-drugs designated by the Minister of Health, Labour and Welfare under the provisions of Article 20, Paragraph 2 of the Enforcement Order of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Showa 36, Ordinance No. 11))
4. Enzymes and their preparations
5. Preparations of cysteine and its hydrochloride
6. Preparations of thiamine, its derivatives, and their salts
7. Preparations of thioglycolic acid and its salts
8. Preparations of tocopherol
9. Lactic acid bacteria and their preparations
10. Foaming agent type preparations
11. Preparations of para-phenylenediamine and other oxidative dyes
12. Preparations of vitamin A oil
13. Powder of pyrethroid insecticide ingredients
14. Poison bait or powder of organophosphorus insecticide ingredients
15. Preparations of retinol and its esters
16. Quasi-drugs for which the expiration date is set as an approved item based on the provisions of Article 14 or Article 19-2, in addition to those listed above

Ministry of Health, Labour and Welfare Notice No. 116 of 1980 (Showa 55)

Types

For quasi-drugs, it is obligatory to display the type on the container etc. according to the above classification.

For those that are not machinery or equipment used for the purpose of exterminating rats, flies, mosquitoes, fleas and other similar organisms for the health of humans or animals, as defined by Article 2, Paragraph 2, Item 2 of the Japanese Pharmaceuticals and Medical Devices Act, it is necessary to display “Pest Control Quasi-Drug”.

Furthermore, for pest control quasi-drugs excluding those directly used on the human body such as lice extermination insecticides, it is also necessary to display “Caution – Do not use on the human body”.

Also, “Designated Quasi-Drugs” designated by the Minister of Health, Labour and Welfare based on the provisions of Article 59, Item 7 of the Japanese Pharmaceuticals and Medical Devices Act, require the display of “Designated Quasi-Drug”.

And for other quasi-drugs (the aforementioned 6 items), it is necessary to display “Quasi-Drug”.

The phrases that should be displayed are as follows:

• Quasi-drugs under Article 2, Paragraph 2, Item 2 of the Japanese Pharmaceuticals and Medical Devices Act (insecticides, etc.) – “Pest Control Quasi-Drug”, and for those not directly used on the human body, “Caution – Do not use on the human body”
• Designated Quasi-Drugs designated by the Minister of Health, Labour and Welfare based on Article 59, Item 7 of the Japanese Pharmaceuticals and Medical Devices Act – “Designated Quasi-Drug”
• Others – “Quasi-Drug”

Name, Content, etc.

For those that fall under quasi-drugs, it is also necessary to display the following contents related to the product:

• Name or title and address of the manufacturer or seller (Article 59, Item 1 of the Japanese Pharmaceuticals and Medical Devices Act)
• Name of the quasi-drug (Article 59, Item 4 of the Japanese Pharmaceuticals and Medical Devices Act)
• Manufacturing number or manufacturing symbol (Article 59, Item 5 of the Japanese Pharmaceuticals and Medical Devices Act)
• Weight, dosage, or quantity, etc. (Article 59, Item 6 of the Japanese Pharmaceuticals and Medical Devices Act)
• Certain matters for quasi-drugs for which standards have been set by the provisions of Article 42, Paragraph 2 of the Japanese Pharmaceutical Affairs Law (Article 59, Item 11 of the Japanese Pharmaceuticals and Medical Devices Act)

Please note that there are no actual quasi-drugs for which standards have been set by the provisions of Article 42, Paragraph 2 of the Japanese Pharmaceutical Affairs Law.

Name of Ingredient

For pest control quasi-drugs and designated quasi-drugs, it is necessary to display the name of the active ingredient (if there is a generic name, the generic name) and its quantity based on Article 59, Paragraph 7 of the Japanese Pharmaceuticals and Medical Devices Act.

Also, for quasi-drugs containing ingredients designated by the Minister of Health, Labour and Welfare, it is obligatory to display the name of that ingredient.

For example, there is a notice that quasi-drugs containing fragrances (those directly used on the human body) need to display that they contain fragrances (Notice No. 1330 of October 9, 1980 (Showa 55)).

Others

In addition to the above, based on the provisions of Article 52, Paragraph 1, Item 1, which is applied mutatis mutandis by Article 60 of the Japanese Pharmaceuticals and Medical Devices Act, it is necessary to describe the usage, dosage (approved usage and dosage), and other necessary precautions for use and handling in the package insert of the quasi-drug.

Also, there are cases where items to be displayed are defined by individual notices for quasi-drugs.

On the other hand, the following items are prohibited from being described under Article 54, which is applied mutatis mutandis by Article 60 of the Japanese Pharmaceuticals and Medical Devices Act:

• False or misleading matters
• Unapproved efficacy or effects
• Usage, dosage, or usage period that is dangerous for public health

Check the Ministry of Health, Labour and Welfare’s Notice for Quasi-Drug Labeling Regulations

Although the regulations for quasi-drugs are more relaxed compared to pharmaceuticals, there are still many matters to confirm when it comes to manufacturing and selling them, compared to other products.

Particularly regarding labeling obligations, there are detailed regulations for each quasi-drug product.

Moreover, these labeling regulations are often determined not by the Japanese Pharmaceuticals and Medical Devices Act, but by notices from the Ministry of Health, Labour and Welfare. Notices are easier to amend than laws, and it can be harder to understand when amendments have been made compared to laws.

Therefore, when actually dealing with quasi-drugs, it is necessary to investigate the latest notices from the Ministry of Health, Labour and Welfare for each product.

Conclusion: Consult a Lawyer if You’re Struggling with the Display Obligations of Quasi-Drugs

When dealing with quasi-drugs, you must pay attention to many regulations. We hope you now understand this.

If you’re not accustomed to handling quasi-drugs, it might be difficult to suddenly comply with all the regulations.

If you’re unable to research all the regulations and are unsure about the content of the display obligations, we recommend consulting with a specialized lawyer.

Introduction to Our Firm’s Measures

Monolith Law Office is a legal office with high expertise in both IT, particularly the internet, and law. The Japanese Pharmaceuticals and Medical Devices Act, which involves quasi-drugs, is specialized in nature, thus increasing the need for legal checks. Our firm is taking measures related to this Act.