Legal restrictions on CBD products

Regulations under the Marijuana Control Law

Definition of “Marijuana” under the Marijuana Control Law

Under the Cannabis Control Law, the term “marijuana” refers to cannabis grass (Cannabis sabativa L.) and its products, and as a rule, the cannabis grass itself and products made from the cannabis grass are considered “marijuana” (Article 1 of the Cannabis Control Law).

Licenses for Marijuana Handlers

Persons other than marijuana handlers licensed by prefectural governors are prohibited from possessing, cultivating, receiving, or handing over marijuana (Article 3 of the Marijuana Act). In addition, marijuana handlers are prohibited from handing over marijuana to persons other than marijuana handlers (Article 13 of the Marijuana Law). As a result, marijuana may not be sold to general consumers.

Penalties for cultivation, import and export of marijuana

Under the Marijuana Control Law, a person other than a marijuana handler who cultivates, imports, or exports marijuana shall be punished by imprisonment for not more than seven years. In addition, cultivation, import or export of marijuana for commercial purposes is punishable by imprisonment for not more than 10 years and a fine of not more than 3 million yen (Article 24 of the Marijuana Law).

Possession, transfer, or assignment of marijuana

Under the Marijuana Control Law, a person other than a marijuana handler who possesses, receives, or transfers marijuana shall be punished by imprisonment for not more than five years. In addition, if a person possesses, receives, or transfers marijuana for profit, he/she shall be punished by imprisonment for not more than 7 years and a fine of not more than 2 million yen (Article 24-2 of the Marijuana Law).

If it does not fall under marijuana

Article 1 of the Marijuana Law states that “marijuana means marijuana grass and its products,” while the proviso states that “however, mature stems of marijuana grass and its products (excluding resin) and seeds of marijuana grass and its products are excluded.

What is CBD (Cannabidiol)?

CBD (cannabidiol) is one of the ingredients found in cannabis grass, which, unlike marijuana, does not contain hallucinogens. CBD is believed to have calming and stress-relieving effects. CBD-containing gummies, pills, and oils are purchased with the expectation that they will have these effects.

Legality of CBD (Cannabidiol)

Marijuana contains THC (tetrahydrocannabinol), a hallucinogenic ingredient. The trade of marijuana is illegal under the Cannabis Control Law. On the other hand, CBD (cannabidiol), “the mature stems of the cannabis plant and its products, and the seeds of the cannabis plant and its products,” does not contain the hallucinogenic component (THC). Therefore, CBD (cannabidiol) products are not considered to be “cannabis” (Article 1 of the same law) and can be legally imported and sold.

When CBD (cannabidiol) is illegal

However, CBD (cannabidiol) may also be laced with a hallucinogenic ingredient (THC). In this case, the product in question would fall under the category of marijuana, and therefore cannot be imported, sold, traded, or possessed”.

Import of CBD (Cannabidiol) products

Pre-verification procedures

If you wish to import CBD (cannabidiol) products , you must obtain prior confirmation from the Drug Control Department (commonly known as “Matori”) of the Kanto Shinetsu Health and Welfare Bureau of the Ministry of Health, Labor and Welfare that the product does not fall under the category of marijuana (Article 70 of the Customs Law). Based on the submitted materials, the MHLW will confirm whether or not the product being imported does not fall under the category of marijuana.

Documents to be submitted

The following documents are to be submitted to the Drug Control Department (Matori) of the Kanto Shinetsu Health and Welfare Bureau of the Ministry of Health, Labour and Welfare during the pre-confirmation stage.

1 Certificate
A document certifying that the CBD product is extracted and manufactured from the mature stems or seeds of the cannabis plant
2 Component Analysis Sheet
Written analysis of each lot of CBD (cannabidiol) products with test results
3 Photo
Pictures of raw materials and manufacturing process of CBD (Cannabidiol) products

If THC (tetrahydrocannabinol) is detected

If the product in question is considered to contain THC (tetrahydrocannabinol) components at the pre-screening stage of the Drug Control Department (Matori) of the Kanto Shinetsu Bureau of Health and Welfare of the Ministry of Health, Labor and Welfare, it will not be allowed to be imported. In addition, even if the product is determined not to fall under the category of marijuana at the preliminary screening stage by the Drug Control Department (Matori) of the Kanto Shinetsu Bureau of the Ministry of Health, Labor and Welfare, importation of CBD (cannabidiol) products will also be prohibited if THC (tetrahydrocannabinol) components are detected at the customs inspection stage. However, under the Cannabis Act, whether a product constitutes cannabis is to be determined based on whether it is “a product manufactured from the mature stems and seeds of the cannabis plant,” and not whether it contains THC (tetrahydrocannabinol) components. Therefore, there seems to be a gray area regarding the treatment of cases where very small amounts of THC (tetrahydrocannabinol) ingredients are included.

Regulations under the Pharmaceutical Affairs Law

Regulated by the Pharmaceutical Affairs Law

The “Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices” (Pharmaceutical Affairs Agency Law) regulates pharmaceuticals, quasi-drugs and cosmetics.

About Pharmaceuticals, Quasi-drugs and Cosmetics

A “pharmaceutical product” is , a medicine intended to diagnose, treat, or prevent disease, and the effectiveness of the active ingredients contained in the product has been approved by the Ministry of Health, Labor and Welfare. There are ethical drugs purchased at pharmacies based on prescriptions from physicians and dentists, and over-the-counter drugs purchased at pharmacies and drugstores with the advice of pharmacists and other professionals.

“Quasi-drugs” are products that contain ingredients approved by the Ministry of Health, Labour and Welfare (MHLW) for efficacy and effectiveness in a certain concentration. Quasi-drugs are products that are approved to have a certain level of efficacy for the treatment of diseases, but the efficacy is relatively weak. Quasi-drugs are designed for the prevention of disease and health and hygiene rather than for the treatment of disease. Quasi-drugs can be purchased outside of pharmacies and drugstores.

“Cosmetics” are products used for cosmetic purposes. They are intended to improve beauty and maintain healthy skin or hair, and have limited effects on the human body.

Application of the Pharmaceutical Affairs Law to CBD (cannabidiol) products

CBD (Cannabidiol) products are not classified as drugs or quasi-drugs. Therefore, no license is required for the manufacture, sale, import/export of CBD (cannabidiol) products as a drug or quasi drug. However, there is no possibility that the legal regulations will change in the future, and the product will be judged as a pharmaceutical or quasi-drug and subject to the regulations of the Pharmaceutical Affairs Law.

CBD (cannabidiol) products may fall under the category of “cosmetics” as defined by the Pharmaceutical Affairs Law. In this case, a license under the Pharmaceutical Affairs Law is required for the manufacture, sale, import/export of CBD (cannabidiol) products.

Permission to engage in the manufacture and sale of cosmetics

When purchasing from a domestic manufacturer

When purchasing domestically manufactured cosmetics from domestic manufacturers (manufacturers and distributors) or domestic wholesalers (wholesalers and dealers), a permit is not required. This is because the quality and safety of these cosmetics are guaranteed because they are manufactured or imported by licensed manufacturers.

For OEM manufacturing

If you outsource the manufacture of cosmetics planned by your company to a domestic manufacturing factory (a factory with a manufacturing license) and sell them under your company’s name, a cosmetics manufacturing and sales license is required. However, if you have an OEM manufacturer who has a manufacturing and sales license, no special license is required.

Purchasing foreign products from a domestic importer

A permit is not required when purchasing cosmetics manufactured overseas from a domestic importer (manufacturer/distributor) or domestic wholesaler (wholesaler/dealer). This is because the domestic importer or domestic wholesaler has obtained a license and guarantees the quality and safety of the product.

Importing directly from an overseas manufacturer

For cosmetics manufactured overseas, if you purchase directly from overseas, you are required to obtain a Cosmetics Manufacturing and Sales License. If your company imports cosmetics manufactured overseas and sells them in Japan as your own products, you will need both a “cosmetics manufacturing business” permit and a “cosmetics sales business” permit. Although it may seem that importing cosmetics from overseas is importing and not manufacturing, when importing cosmetics directly from overseas, it is necessary to conduct ingredient testing and labeling of ingredients in Japan, and thus falls under the category of “manufacturing business”.

Inability to state a medical efficacy benefit

Inability to describe pharmaceutical effects or benefits

The “Act on Quality, Efficacy and Safety Assurance of Drugs and Medical Devices” (Pharmaceutical Affairs Law) defines drugs for the purpose of diagnosis, treatment, or prevention of disease as pharmaceutical products and allows them to be sold only after obtaining prior approval. In addition, if the product contains ingredients that are effective in terms of efficacy and efficacy approved by the MHLW in a certain concentration, it is approved as a quasi-drug. Efficacy may only be stated if the product has received this approval.

Article 68 of the Pharmaceutical Affairs Law

If a product is to promote pharmaceutical-like efficacy, such as the treatment or prevention of disease or the enhancement of bodily functions, regardless of its ingredients or actual effects, it is considered to be a drug and cannot be sold unless prior approval is obtained. As a result, labeling a product that is not a drug or quasi-drug (i.e., one that has not been certified as a drug or quasi-drug) as having certain expected effects or benefits is in violation of the Pharmaceutical Affairs Law (Article 68, Pharmaceutical Affairs Law).

Advertisements for CBD products

Health foods, supplements, cosmetics, and luxury goods are sold without approval for efficacy. CBD products cannot be approved for efficacy at this time. Therefore, it is not possible to list a therapeutic or preventive effect for the treatment of disease.

Statements regarding stress, sleep, concentration, etc.

CBD ingredients are said to be effective in relieving stress and improving sleep. However, CBD (cannabidiol) products are not approved for efficacy and therefore cannot make statements about their effectiveness for stress, sleep, or concentration.

Advertising regulations for cosmetics

If a CBD (cannabidiol) product is sold as a cosmetic, it is possible to describe its cosmetic efficacy. Expressions such as “conditions the skin,” “is gentle on the skin,” or “moisturizes the skin” are cosmetic benefits and may be included in the advertisement.

On the other hand, expressions such as “to correct rough skin” or “to treat acne” are medical efficacy claims. For cosmetics, medical efficacy claims are not allowed (Article 68 of the Pharmaceutical Affairs Law). Therefore, if a CBD (cannabidiol) product is sold as a cosmetic, it cannot be described as having a medical efficacy.

Relationship with the Law for Preventing Unjustifiable Premiums and Misleading Representations

Unjustifiable Premiums and Misleading Representations Act prohibits misleading or exaggerated advertisements. Therefore, advertising a product as superior without any reason or using exaggerated expressions that mislead consumers is a violation of the Law for Preventing Unjustifiable Premiums and Misleading Representations.