Revision of Japan's Cannabis Control Act, etc. and CBD products

2022年6月23日 2023年7月13日

mogu@oggo.jp

[bogo]

As many of you know, cannabis is very strictly regulated in Japan and many "good" people in Japan have the impression that cannabis is an illegal drug. (There is a very well-known slogan of "Dame. Zettai." in the government's anti-drug campaign.)

So to be honest, Japan is not a friendly country for cannabis-related businesses.
However, the revision of "Cannabis Control Act" and "Narcotics and Psychotropics Control Act" (hereinafter referred to as the "Cannabis Control Act, etc."), which are the core of Japan's cannabis regulation, is currently under consideration. (* 1)

I'm an Gyoseishoshi involved in pharmaceutical affairs in the healthcare field, and I've consulted on the import of CBD (cannabidiol) products in the past, so I'm paying close attention to this revision.

Current regulations around CBD

Even in Japan, it does not mean that "If it comes from cannabis, it's an illegal drug."
In the case of CBD products, even if they are derived from cannabis, they are not considered to be "illegal cannabis" if the following two conditions are met. (* 2)

Regulation for the part of the plant: It is extracted and manufactured only from the mature stems and seeds of cannabis grass (Cannabis sativa el)
Regulation for the Ingredients: Does not contain designated drugs such as THC, HHC, and THCP (hereinafter referred to as "THC and other designated drugs").

And to prevent this "illegal cannabis" from being brought in from abroad, the Japanese drug control department is demanding importers of CBD products to submit the following documents before importing to confirm that the product is "not illegal cannabis".
*In the case of synthetic CBD, it is necessary to submit a certificate about raw materials and synthetic method and a component certificate.

Certificate and photo certifying the part used
Ingredient certificate

However, there are some points in this rule that are difficult to interpret when actually trying to import CBD products.

Question 1_ Is site regulation necessary?

I wonder
・ In the first place, for the purpose of not bringing designated drugs such as THC into Japan, isn't the ingredient regulation alone sufficient?
・ Isn't the part regulation just a heavy burden on the importer?

Among the overseas manufacturers that produce CBD, it seems that there are quite a few manufacturers that extract and manufacture CBD only from the mature stems and seeds of cannabis grass, and I heard the person who is going to import CBD products to Japan are having a lot of trouble to find the supplier.

Question 2_Actually, there is a range of "not detected"?

Ingredient analysis is performed to prove that it does not contain designated drugs such as THC.
However, analytical instruments have a detection limit, which is "the amount less than this is too small for me to notice."
Therefore, even if it is "not detected", it may actually be contained in a very small amount.

At present, it seems that there is no document that clearly defines the method of component analysis and the detection limit for the import of CBD products.

In other words, there is a possibility that it will not be detected by the manufacturer's inspection (below the detection limit of the equipment used by the manufacturer), but will be detected by the inspection of the customs or the Ministry of Health, Labor and Welfare (more than the detection limit of the equipment used by the customs or the Ministry of Health, Labor and Welfare). There is.

If the judgment criteria are not clear, businesses that are trying to do business in compliance with laws and regulations cannot be relieved. This is not good:(

If it's legal, make it a safe business

As already mentioned, it is legal to distribute CBD products that have passed the regulations in Japan.
However, I personally feel that those regulations should be updated soon.

I also think that businesses will have to make efforts to gain the understanding of general consumers because CBD is a ingredient that is difficult to separate from the image of "cannabis," which is still taboo-conscious in Japan.
Therefore, it is important for each business operator to understand and comply with the law (not to slip through the gaps in the law).
In the future, as an industry group, voluntary standards and fair competition rules may be formulated.

I would like to keep an eye on the movement toward the revision of the Cannabis Control Act, etc., hoping that the movements of Japan the country and businesses will be a step toward the win-win-win future of the three sides of the country, consumers, and businesses.

Oggo.jp

CBD products come in a variety of forms, but all can basically be sorted into cosmetics, miscellaneous goods, or food. (Limited to items normally available in Japan.)
The procedure for distributing them in Japan is different.
If it is a good product, I would like you to sell it with a firm regulatory strategy so that you can be proud to deliver it to consumers.
Especially for CBD, which has finally begun to spread in Japan, legal cleanliness is also important for future markets.

Oggo.jp

Oggo.jp supports people who are thinking of doing business in the healthcare field in Japan.
Our office provides consulting not only for license-related procedures, but also for sellers' worries such as "I can't decide which way is better, whether to cosmetics or to miscellaneous goods!" Or "I don't know about the rules to sell in Japan."
The first consultation is free.
Please feel free to contact Oggo.jp whether you are in the planning stage or have a product already in hand.