Overview of Cannabis and Cannabinoid Regulation in Japan

Under the current Cannabis Control Act in Japan, the possession, transfer, acceptance, importation and exportation of cannabis plants and their products are prohibited, except for possession by a person with a licence to cultivate or research cannabis plants. No one is allowed to engage in any medical or recreational use of cannabis plants and their products, and cultivation of cannabis plants is also prohibited, except by a person with a cultivation or research licence. As the Japanese government has been very reluctant to issue cultivation licences, there were only 27 licensed cultivators as of 31 December 2022. In other words, the market for cannabis plants and their products is virtually non-existent in Japan.

However, the mature stems and seeds of cannabis plants and their products are exempt from regulation under the Cannabis Control Act. Therefore, there is a market for products of cannabis seeds such as animal feed, essential oil materials, and spices, as well as for products of mature cannabis stems such as textile products and traditional products used in Shinto rituals.

For the purposes of this article and for common understanding, the following definitions are provided for certain key terms:

• cannabis plant – cannabis sativa Linn;
• cannabis – cannabis plant excluding its mature stems and seeds (eg, leaves, flower heads, resin and immature stems); and
• cannabis product – product made from cannabis.

The Japanese government designates many controlled substances as having harmful effects and as likely to be abused as narcotics. The possession, use, transfer, acceptance, manufacture, importation and exportation of narcotics are prohibited, with penalties, under the Narcotics and Psychotropics Control Act. Cannabis and cannabis products are regulated under the Cannabis Control Act, and the possession, transfer, acceptance, importation and exportation of these substances and products are prohibited, with penalties.

The rate of drug use among Japanese citizens is remarkably low compared to that of other countries. According to one study, the lifetime experience rate of cannabis use in Japan is only 1.4%, compared to 20–40% in the United States and Europe. As can be seen from these experience rates of drug use, the Japanese government is generally very strict in its enforcement on drug crimes, including those related to cannabis.

Medical Cannabis and Cannabinoid

The Cannabis Control Act strictly prohibits the possession, transfer, acceptance, importation and exportation of cannabis and cannabis products, regardless of the purpose of use. Both recreational use and medical use, even by medical professionals, of cannabis and cannabis products are prohibited in the same manner. There is no licensing or approval system allowing any use of cannabis or cannabis products in Japan.

In light of the recent change to the regulatory category of cannabis in the Single Convention on Narcotic Drugs, 1961, and the approval of pharmaceutical products derived from cannabis in the United States and Europe, the Japanese government is considering revising the Cannabis Control Act to lift the ban on the use and possession of cannabis as a pharmaceutical product. For details, see the Outlook for Law Reform Regarding Cannabis section below.

Hemp Regulation in Japan

The current Cannabis Control Act regulates cannabis without distinguishing between marijuana and hemp. The Act prohibits the cultivation of cannabis plants by anyone other than holders of a cultivation or research licence, regardless of the Delta-9-THC content of the cannabis plant, as long as the plant being cultivated qualifies as a cannabis plant. Therefore, the term “cannabis plant” as used in this article includes hemp, which has a low THC content.

The Cannabis Control Act prohibits the possession, transfer, acceptance, importation and exportation of cannabis and cannabis products, except for mature stems and seeds and their products which are not included in the definition of cannabis.

Thus, any product made from cannabis, regardless of whether or not it contains Delta-9-THC, is subject to the Cannabis Control Act. For example, even a CBD product that does not contain Delta-9-THC is subject to regulation if the product is made from cannabis, or from the regulated parts (ie, leaves, flower heads, resin and immature stems) of cannabis plants.

For Delta-9-THC and Delta-8-THC, which are not extracted from the regulated parts (ie, leaves, flower heads, resin and immature stems) of cannabis plants and are chemically synthesised, the possession and transfer of products containing such Delta-9-THC and Delta-8-THC are prohibited as narcotics under the Narcotics and Psychotropics Control Act, and not under the Cannabis Control Act.

Permitted Products/CBD Products

Any possession, transfer, acceptance, importation or exportation of any cannabis products is prohibited, with penalties. In other words, the following are subject to regulation under the Cannabis Control Act:

• cannabis, which covers regulated parts (such as leaves, flower heads, resin and immature stems) of cannabis plants but excludes their mature stems and seeds; and
• cannabis products, which are products made from cannabis.

The mature stems and seeds of cannabis plants do not fall within the definition of cannabis and can, therefore, be manufactured and distributed. In short, fiber products made from mature stems or seed products (eg, animal feed, essential oil ingredients and spices) are legal products. There are no specific restrictions under drug control regulations, including the Cannabis Control Act, on businesses related to the manufacture and distribution of such products.

In recent years, CBD products or CBD as a raw material have been imported from foreign countries and distributed in the Japanese market. It is legal to import into and distribute CBD products in Japan as long as they are made exclusively from mature stems or seeds of cannabis plants and do not contain any ingredient made from other regulated parts (such as leaves, flower heads, resin or immature stems) of cannabis plants.

The reason that mature stems of cannabis products are exempt from regulation is to allow the production, distribution and use of hemp as a fiber product, which is distributed in traditional industries in Japan. A Japanese court defined the “mature stems” of cannabis plants as “the portions of the stems (excluding twigs) that have reached a state suitable for collecting cannabis plants as a fiber product”.

Production and Processing of Cannabis Products and Cannabis Plants

No cannabis product may be legally manufactured or produced under the Cannabis Control Act.

A licence may be granted for the cultivation of cannabis plants only for the purpose of collecting fiber or seeds. In this case, licensed cultivators must harvest the cannabis plants by separating only the mature stems or seeds and discarding (by burning) all other regulated parts within their cultivation area.

Applications for a licence to cultivate cannabis plants must be made to the governor of the prefecture where the cultivation area is located. A cultivation licence is valid for a maximum of one year, and must be renewed every year. The processing time for a licence varies from one prefecture to another, with some prefectures requiring 15 days and others requiring 60 days. The application fee also varies between prefectures, but is generally less than JPY10,000.

In practice, however, prefectures are broadly reluctant to grant cultivation licences, and grant licences only in cases where the purpose of the cultivation is clearly considered useful from a social perspective, such as for manufacturing products used in traditional Japanese culture.

In recent years, the Japanese government has been considering major revisions to the Cannabis Control Act. Depending on the details of the proposed revisions, it may become possible to process and manufacture certain cannabis products, so it is necessary to keep a close eye on future developments. As of October 2022, a panel of experts convened by the Ministry of Health, Labour and Welfare (MHLW) had discussed revisions to the Cannabis Control Act to permit the manufacture and distribution of cannabis products with THC levels below a certain threshold, and also the granting of licences for the cultivation of cannabis plants for the purpose of producing such cannabis products. For details, see the Outlook for Law Reform Regarding Cannabis section below.

Distribution and Sale of Cannabis Products

Currently, no cannabis product may be legally distributed or sold in Japan because the possession, transfer, acceptance, importation and exportation of cannabis and cannabis products are prohibited, with penalties. In addition, as indicated in the Advertising and Promotion of Cannabis Products section below, any advertising of cannabis and cannabis products is prohibited, with penalties.

However, the mature stems and seeds of cannabis plants are not considered cannabis, and products made from such parts can be manufactured and distributed. In recent years, CBD products or CBD as a raw material allegedly made from mature stems have been imported from foreign countries and distributed in the Japanese market.

Nevertheless, if a CBD product made from mature stems is found to contain Delta-9-THC, then it will be considered as likely to have been made from regulated parts (eg, leaves, flower heads, resin and immature stems) of cannabis plants and will be subject to regulatory inspections and other actions. In fact, there have been several cases where Delta-9-THC has been detected in CBD products distributed in the Japanese market, and the regulatory authorities have issued warnings to the market and requested the distributors to perform a voluntary recall. Therefore, it is vitally important for any CBD business in Japan to ensure the product is totally THC-free.

Testing, Research and Development of Cannabis

The Cannabis Control Act prohibits the possession, transfer, acceptance and use of cannabis for research purposes other than by a person who has a licence for academic research relating to cannabis.

Similar to cultivation licences (as previously discussed), applications for a cannabis research licence are made to the prefectural governor. The licence is valid for a maximum of one year and must be renewed annually. The processing time for a licence varies from one prefecture to another, with some prefectures requiring 15 days and others requiring 60 days. The application fee also varies between prefectures, but is generally less than JPY10,000.

A cannabis research licence will not be granted to:

• a person who is addicted to narcotics, marijuana or opium;
• a person who has been sentenced to imprisonment or a greater penalty;
• a minor; or
• a person who is unable to properly recognise, judge and communicate in a manner necessary for the proper performance of the duties of a researcher due to any mental dysfunction.

In practice, however, cannabis research licences are granted only to scholars for academic research purposes or to persons affiliated with public institutions for criminal investigation research. Currently, cannabis research licences are not granted for any research relating to the development and testing of cannabis products for commercial purposes.

Advertising and Promotion of Cannabis Products

Under the Cannabis Control Act, any person is prohibited, with penalties, from advertising cannabis and cannabis products. Violation is punishable by imprisonment of up to one year or a fine of up to JPY200,000. Since the possession, transfer, acceptance, importation and exportation of cannabis and cannabis products are prohibited even for medical purposes, there is legally no market for the branding, advertising or promotion of cannabis or cannabis products in Japan.

However, there are no specific regulations regarding advertisements for a product made from mature stems or seeds of cannabis plants, which are not subject to the Cannabis Control Act. Therefore, advertisements of CBD products made from mature stems of cannabis plants are not prohibited, and in fact such advertisements can be seen in Japan. In addition, there are no specific regulations regarding the packaging or labelling of legally permitted CBD products.

However, a CBD product is legal only to the extent that mature stems of cannabis plants are used as raw materials and the product itself does not contain THC. Therefore, the advertising, packaging or labelling of a CBD product that indicates that it is made from regulated parts (such as leaves, flower heads, resin and immature stems) of cannabis plants is not permitted. Furthermore, the advertising, packaging or labelling of CBD products containing THC is not permitted.

In addition, under the Pharmaceuticals and Medical Devices Act, any advertising of unapproved pharmaceutical products is prohibited. Any advertisement of a product that claims any efficacy for a specific disease (ie, that it is for medical use) is considered an advertisement for an unapproved pharmaceutical product. Therefore, it is important for those operating a CBD product business to avoid making such a claim of efficacy for their CBD products.

International Trading of Cannabis Products

The importation and exportation of cannabis and cannabis products are prohibited, with penalties, under the Cannabis Control Act. However, as an exception, licensed cannabis researchers may import or export cannabis or cannabis products provided that they have separate permission from the MHLW.

Conversely, there are no legal restrictions on the importation and exportation of mature stems and seeds of cannabis plants or products made from them, as they are not subject to the Cannabis Control Act. Therefore, CBD products made from mature stems of cannabis plants can be legally imported into Japan.

A person wishing to import a CBD product is required to obtain the confirmation of the MHLW that the CBD product is not made from regulated parts (such as leaves, flower heads, resin and immature stems) of cannabis plants. Specifically, before any importation, the following documents must be submitted to the Regional Bureau of Health and Welfare:

• a document certifying that the CBD product was extracted and manufactured from mature stems or seeds of cannabis plants;
• a THC and CBD component analysis report; and
• photographs of the raw materials and the manufacturing process of the product.

It should be emphasised, however, that regardless of the submission of the documents described above, if the CBD product in question contains even a small trace of THC, the authorities will assume that the product may contain or may have used restricted parts (such as leaves, flower heads, resin and immature stems) of cannabis plants, and the importation of the product will not be allowed.

Therefore, a person wishing to import a CBD product into Japan must not only ascertain the raw materials of the product but also ensure that the product does not contain any THC.

Seeds of cannabis plants can also be imported as unregulated parts under the Cannabis Control Act; however, only seeds that have been processed for non-germination are allowed to be imported under the Import Trade Control Order.

Penalties Under Cannabis and Cannabinoid Regulation

Under the Cannabis Control Act, the possession, transfer and acceptance of cannabis and cannabis products are prohibited except for licensed cultivators and researchers. The possession, transfer or acceptance of cannabis or cannabis products are punishable by imprisonment of up to five years, and in the case of possession or transfer for profit, by imprisonment of up to seven years.

As explained under Advertising and Promotion of Cannabis Products above, any advertising by any person pertaining to cannabis or cannabis products is also prohibited. Violation is punishable by imprisonment of up to one year or a fine of up to JPY200,000.

The cultivation of cannabis plants by a person other than a licensed cultivator or researcher is also prohibited. The unauthorised cultivation of cannabis plants is punishable by imprisonment of up to seven years, and in the case of cultivation for profit, by imprisonment of up to ten years.

Even a licensed cultivator of cannabis plants must obtain a separate permission from the prefectural governor in order to take cannabis outside the approved cultivation area. Any unauthorised taking out may be punishable by imprisonment of up to five years, and in the case of taking out for profit, by imprisonment of up to seven years. Moreover, a licensed cultivator of cannabis plants is obligated to report once a year to the prefectural governor on:

• the acreage used for the cultivation of cannabis plants during the previous year; and
• the amount of cannabis plant fiber collected during the previous year.

Violation of this reporting obligation may result in imprisonment of up to one year or a fine of up to JPY200,000.

Outlook for Law Reform Regarding Cannabis

The Japanese government is closely monitoring trends in other jurisdictions regarding their treatment and attitude towards cannabis. In recent years, pharmaceutical products made from cannabis have actually started being approved and marketed in the United States and Europe. In addition, given the recognition of the medical usefulness of pharmaceutical products made from cannabis, the regulatory category of cannabis in the Single Convention on Narcotic Drugs, 1961 was reclassified from Schedule IV (that is, selected drugs from Schedule I that are considered to have particularly dangerous properties and limited or no therapeutic use) to Schedule I (that is, drugs the control provisions of which constitute the standard regime under the 1961 Convention), a category that includes substances that may also have medical usage.

In contrast, the current Cannabis Control Act prohibits any use of cannabis, even for medical purposes. Therefore, in light of the above-mentioned trends in other countries, the Japanese government has begun to consider major revisions to the Cannabis Control Act in order to lift the ban on the use of cannabis as an ingredient of pharmaceutical products.

In addition, the upcoming revision of the Cannabis Control Act is also expected to include revisions related to CBD products, the distribution of which has been increasing in Japan. Depending on the actual revisions to the Cannabis Control Act, the manufacture and distribution of certain cannabis products may become possible in Japan, so it is necessary to pay close attention to this trend.

According to discussions of a panel of experts convened by the MHLW, as of October 2022:

• the use of cannabis as an ingredient of pharmaceutical products will be legally permissible;
• the manufacture and distribution of cannabis products, such as CBD products, with THC content below a certain concentration will be legally permissible; and
• the government may also grant a cultivation licence for commercial purposes such as the manufacture of cannabis products, as long as the THC content of the cultivated cannabis plants is below a certain concentration.

To date, a draft of the revised Cannabis Control Act has not yet been released. Thus, interested players must continue to monitor the legislative and policy developments closely.