While recently there has been an increase in attention to cannabis-related businesses (CBD businesses, medical marijuana, etc.) globally, there are many problems with Japan’s laws and regulations pertaining to cannabis.
Although the regulations are currently under review and may be revised in the future, the following is premised on the current law as of the time this article was prepared.
Cannabis, which is subject to regulation under the Cannabis Control Act, is defined as “the cannabis plant (Cannabis Sativa L.) and its products; provided, however, that the grown stalk of the cannabis plant and its products (excluding resin.) and the seed of cannabis plant and its products are excluded” in Article 1 thereof, while mature stems and seeds, including their products (except for resin from mature stems), are exempt from regulation (“regulated site”).
On the other hand, the Ministry of Health, Labor, and Welfare (“MHLW”) and Japan Customs do in fact regulate cannabis products based on the presence of tetrahydrocannabinol (“THC”), an intoxicating ingredient found in the cannabis plant (the MHLW website publicizes CBD products in which THC was detected after it was sold in Japan).
In theory at least, cannabis products can be divided into categories (1) through (4) below, of which only (1) and (2) are explicitly regulated under the Cannabis Control Act, whereas there is a possibility that (3) may be subject to regulation.
- Derived from a regulated site and contains THC.
- Derived from a regulated site and does not contain THC.
- Not derived from a regulated site and contains THC.
- Not derived from a regulated site and does not contain THC.
THC has at least seven isomers, all of which are designated as narcotics under the Narcotics and Psychotropics Control Act and related government ordinances, but products necessary for the purification of the two THC isomers (Δ8-THC and Δ9-THC) whose inclusion in cannabis plants is particularly problematic are excluded, and only products derived from chemical synthesis are subject to the regulation.
Therefore, there is no clear statutory basis for including (3) in the scope of regulation, and its legitimacy is questionable from the standpoint of the principle of legality.
Even so, in practice, the aforementioned conditions must be taken into account, and under the current circumstances, if one wishes to avoid the risk of being subject to penalties, product recalls, and other disadvantages when conducting a cannabis business in Japan, a reasonable response would be to handle only cannabis products that are certain to fall under (4) above. However, it is often difficult to ensure that such measures are taken in a realistic manner.
When importing CBD products, the MHLW answers any questions about whether or not the product falls under “cannabis” under the Marijuana Control Act based on data submitted by the importer. However, even if the MHLW responds that it does not fall under the category of “cannabis,” there is still a possibility that it may be determined to fall under the category of “cannabis” due to THC detection or other circumstances at a later date.
In addition, the regulations under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices can also be problematic for CBD products, one example of which is the issue of food-drug classifications.
In other words, any product that uses as an ingredient even one of the ingredients listed in the MHLW’s “List of ingredients (raw materials) used exclusively as pharmaceuticals” is subject to strict regulation as a “pharmaceutical ” under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Although CBD is not currently on the list, we cannot deny the possibility that it may be added to the list in the future at the MHLW’s notice, and if so, there is a risk that the handling of non-pharmaceutical CBD products in Japan will be greatly restricted.
When conducting a cannabis business in Japan, it is necessary to pay close attention to the various regulations mentioned above and trends in revisions and changes to their actual status.
