Strict 0,0001% THC limit could isolate Japan from international CBD markets

On May 30, 2024, a seismic shock hit the Japanese CBD industry. In response to the revision of the Cannabis Control Law, the Ministry of Health, Labor and Welfare proposed a new residual THC (tetrahydrocannabinol) limit, which has faced strong reactions, both nationally and internationally. This proposed limit is significantly stricter than international standards, potentially shaking the foundation of Japan's CBD business.

In this article* we will delve into the background of this issue, the details of the proposed new limit, the reactions of national and international experts and the future prospects for Japan.

Background and History of the Review of the Cannabis Control Law

On December 6, 2023, the Japanese government partially revised the “Cannabis Control Law” and the “Narcotics and Psychotropic Drugs Control Law” with the aim of preventing cannabis abuse and, at the same time, considering the legalization of medical cannabis.

To ensure the proper use of cannabis in medical and industrial applications and to prevent health risks caused by its abuse, measures have been implemented by the government of Japan. On the website of the Ministry of Health, Labor and Welfare you can find one overview of the partial revision of the Cannabis Control Law and the Narcotic Drugs and Psychotropic Drugs Control Law (only available in Japanese).

Broadly speaking, the background to the review was as follows:

1. Establish regulations to allow the administration of pharmaceutical products derived from cannabis plants;
2nd Review of regulations related to the application of offenses relating to the use of cannabis and related substances;
3. Implement measures to review regulations relating to the cultivation of cannabis plants.

In the new law, the definition of cannabis has been revised, moving from traditional part-based regulations (banning all parts except mature stems and seeds) to regulations based on THC content.

Therefore, on May 30, 2024, the Ministry of Health, Labor and Welfare proposed a new residual THC limit. The shocking details are as follows:

• Oil (at room temperature): 10ppm (0,001%)
• Beverages: 0,1 ppm (0,00001%)
• Other CBD products such as food and raw materials: 1ppm (0,0001%)

These limits reference standards set by the European Food Safety Authority (EFSA), but these standards are based on outdated values ​​from 2015. Compared to current European and North American standards, these proposed limits are incredibly strict:

• EU: Most countries allow THC contents between 0,2% and 0,3%;
• USA: The federal level allows THC contents up to 0,3%;
• Switzerland and Czechia: allow THC levels of up to 1%.

Previously, Japan did not have explicitly stated residual THC limits and CBD products with up to 200 ppm (0,02%) THC were commonly distributed. The new limits are extremely strict compared to these. Furthermore, interpreting the THC residual limit for raw materials as 1 ppm reveals a clear inconsistency.

National and international experts offer harsh criticism

These strict standards and inconsistencies are far removed from scientific evidence and international standards, attracting strong criticism from CBD operators and experts, both nationally and internationally.

Lack of scientific basis
Many studies on cannabis and CBD indicate that THC content below 0,3% has minimal psychotropic effects and poses extremely low health risks. Despite its wide distribution, there have been no significant reports of health problems. On the other hand, on June 25th, the Japan has established a permissible intake level for perfluoroalkyl substances (PFAS), adopting a “very mild” standard that is 60 times higher than European standards. This decision was made despite a public comment period (which solicited public opinion on the draft decree), where most opposing opinions were ignored.

On the other hand, excessively strict THC standards have been set under the pretext of protecting public health, while on the other hand, too lenient standards have been set for dangerous substances such as PFAS, with limits that are much less stringent than international standards. This contradiction highlights the lack of transparency in the government policy-making process and exemplifies decisions that are not based on scientific evidence.

Significant trade barriers
Currently, the raw materials for CBD products distributed in Japan depend almost entirely on imports. The recently proposed and unrealistically stringent THC residual limits deviate significantly from international standards, creating enormous trade barriers. Experts warn that, with these measures, “Japan is choosing to isolate itself from the international market”.

Health use restrictions and symptom relief
According to new standards proposed by the Ministry of Health, Labor and Welfare, almost all CBD products currently on the market will have to undergo new testing. It is likely that none of the existing CBD products will meet these new standards, leading to their removal from the market. This situation is particularly concerning for individuals who use CBD to maintain their health or to alleviate symptoms.

Currently, the only pharmaceutical product derived from cannabis clearly legal in Japan is “Epidyolex”, used for the treatment of refractory epilepsy, which is a very limited case. Therefore, for those using CBD for other health maintenance or symptom relief purposes, the alternatives are extremely limited.

Increase in wrongful arrests due to false positives
Increasing the sensitivity of tests to detect ultra-traces of THC, as proposed by the new standards, increases the risk of false positives. This could lead to an increase in cases where individuals are wrongly considered to be involved in illegal activities, resulting in more frequent arrests and detentions, as well as unfair crackdowns and legal disputes. As a result, users may find it increasingly difficult to use CBD products with confidence.

Severe Impact of New Standards: Devastation of Japan's CBD Business
As previously mentioned, if the new standards are implemented, it is likely that none of the currently available CBD products will meet these new criteria, resulting in their removal from the market. Several CBD brands have already ended sales and numerous CBD stores have announced closures. This trend threatens to deal a devastating blow to the entire industry, causing job losses and the bankruptcy of related companies. This means that the domestic market estimated at around 24 billion Japanese Yen (more than 141 million Euros) could disappear overnight.

Furthermore, market contraction due to these stringent standards is likely to completely halt CBD-related investment, research and development. Although the CBD business continues to experience rapid growth in the global market, Japan risks falling behind, inevitably leading to a decline in its future international competitiveness.

Direct impact on the quality of life of CBD users
The proposed new regulations will have a severe impact, especially on patients who rely on CBD for health maintenance and symptom relief.

Drastic reduction of options
Many CBD products will disappear from the market, significantly limiting the choices available to users. Below is a public comment submitted by a CBD user, shared with their permission:

“I have fibromyalgia and other conditions and have been using CBD for about four years. When I first encountered CBD, I was in a state where I couldn't eat, due to a physical dysfunction, and I felt constant pain and insomnia. Even now, there are times when I am bedridden, and in those situations I use broad-spectrum CBD oil sublingually. After a while, I can sit up and move again. For the past four years, I have managed my condition without using painkillers, relying solely on CBD. There was a time when I received injections of painkillers and medicines in the hospital. Currently, fibromyalgia is not designated as a rare disease in Japan. Therefore, there is no support available, making it a very difficult condition to manage. Going to the hospital takes time and I used to rely heavily on painkillers, but now I can manage my symptoms at home with CBD, which has also reduced my medical expenses over time. There is research into fibromyalgia and CBD abroad and I have experienced significant relief from complex symptoms throughout my body. I wish this option was available, in addition to traditional painkillers.”

As shown here, in Japan many users rely on CBD for health maintenance and there are concerns that strict regulations will limit their options.

price increase
With the new rules, other problems will arise that will cause an increase in manufacturing and testing costs to comply with strict standards. These costs will be passed on to consumers, which give rise to several concerns:

• How many suppliers and testing facilities have the analytical and extraction capacity to meet these standards?
• How can they be identified?
• Even if there are, what will be the financial charges?

Quality deterioration and loss of effect entourage
With stricter THC residual limits, the market will essentially be limited to isolated, high-purity products. This will result in loss of effect entourage, significantly reducing the benefits for users who rely on CBD for health maintenance and symptom relief.

Security concerns
Many testing facilities will find it extremely challenging to consistently detect trace amounts of THC, as required by the new regulations. To meet these extreme standards, some companies may resort to falsifying Certificates of Analysis (COAs) or increasing distribution through the black market, potentially driving well-regulated products from the market. Could this, in turn, worsen public health problems instead of solving them?

Public Comments and Resistance from the CBD Industry

From May 30th to June 28th, the Ministry of Health, Labor and Welfare carried out a period of public comments on the implementation of the revisions to the Cannabis Control Law and the Narcotic Drugs and Psychotropic Drugs Control Law of the Ministry of Health, Labor and Welfare.

In this link is the basis for calculating the value specified by the Health Risk Abuse Prevention Ordinance (only available in Japanese).

Under the protest cry “Raise Your Voice!”, more than 5.000 critical comments were received from CBD industry stakeholders, healthcare professionals and the general public. The public comment period ended on June 29th and it is now up to the Ministry of Health, Labor and Welfare to decide how to treat the opinions presented. The new standards may be implemented from October 1st.

Establishment of the first industry group led by CBD sellers: National Hemp Industry Council
On June 22, prompted by a request for public comment on new cannabis regulations, the first industry group led by CBD sellers was established: the National Hemp Industry Council. The board of directors includes influential and long-established business operators in the sector. To support the healthy development of the industry, the council is involved in the following activities:

1. Coordination and consolidation of opinions among members involved in economic activities related to the hemp industry;
2. Promoting solid economic development and sustainable growth of the hemp industry;
3. Activities to prevent health risks associated with the misuse of hemp;
4. Development of guidelines and standards for members to follow;
5. Introduction and promotion of the situation and opinions of the hemp industry among the national and international public;
6. Proposing and implementing measures to prevent recurrence of problems and coordinating with relevant government agencies;
7. Collaboration with related industrial organizations to present and resolve common problems;
8. Accumulation of data relating to the safety of final consumer products;
9. Establishment and operation of independent guidelines to protect consumers.

In the short term, the council is preparing to quickly present a formal opinion to the Ministry of Health, Labor and Welfare, defending the correction of residual THC limits.

Voices of Consumer Outrage: Petition and Personal Appeals
On June 17, an online petition titled “Please don't take away our CBD!” was launched on Change.org by a group of volunteers who want to continue using CBD. In a short period, thousands of signatures were collected — at the time of publication of this article there were 27.790.

Additionally, we bring CBD user videos calling for a review of the new standards under their real names went viral, resonating their concerns with many other people.

These actions are proof that users who rely on CBD products daily are worried about a decline in their quality of life, feeling anxiety and anger. Japanese citizens are not normally known for raising their voices, but they are now calling on the government to adopt a more flexible approach, ensuring continued access to these health-promoting products.

Political Actions
Some members of the National Diet recognized the seriousness of this problem. Representatives like Shunsuke Mutai, of the House of Representatives, and Kozo Akino and Satoshi Hamada, from the Chamber of Councillors, expressed strong concerns about the proposed rules via social media.

“Regarding the revision of the Cannabis Control Law, the Ministry of Health, Labor and Welfare has proposed very strict standards for the amount of THC in CBD products, 1/3000 of the US standard and 1/2000 of the WHO standard . Let’s hear from Michael Bobrov, CEO of the Japan Cannabis Industry Association, Nakajima Saki of Nature Can, and Nakazawa Ryota, CEO of Asabis,” wrote Shunsuke Mutai of the House of Representatives on his X (formerly Twitter).

Urgent recommendations from international experts

International experts have issued urgent recommendations to the Japanese government regarding proposed limits on THC.

Ethan Russo, MD – World-renowned neurologist and researcher in the field of cannabinoid psychopharmacology
“Despite decades of selective breeding, it has not been possible to develop a cannabis strain that produces CBD without traceable amounts of THC. The use of genetic modification technology is not advisable due to high costs and the potential for dangerous by-products. Setting the extremely low THC limit introduces technical and toxicity problems in the manufacture of cannabinoid isolates”, says Ethan Russo in a letter sent to Daisaku Sato, Director of the Compliance and Narcotics Division of the Ministry of Health, Labor and Welfare (MHLW) of Japan and published on X by Green Zone.

Andrew Weil, MD – Pioneer of Integrative Medicine (Andrew Weil Center for Integrative Medicine)
“Strict regulation of THC content in CBD products unnecessarily complicates the manufacturing process, leading to higher costs and making it harder for people to access the health benefits of these products. These impractical regulations also encourage fraud and the distribution of unregulated products in illegal markets, posing additional health risks. The Japanese government should reconsider proposed limits for THC and align them with globally accepted standards (e.g. 0,3% in the US, Canada, Australia and EU) and establish a rational supervision framework to ensure quality,” stated in a letter sent to the Japanese government and published in X.

Aaron Smith – CEO and co-founder of the National Cannabis Industry Association (NCIA)
“These restrictions would not only cut off access to valuable health and wellness products for the consumers and patients who depend on them, they would also force many businesses to close. Complying with the proposed new limits is simply not feasible for the vast majority of product manufacturers. Implementing these draconian THC limits will not promote public health and could have the opposite effect. Given that so few manufacturers of legal products will be able to meet these standards and the demand for hemp products continues to increase, the limits will likely drive consumers into a criminal marketplace to obtain these products.” refers to the association in a letter.

Tiffany Coleman – ASTM (American Society for Testing and Materials)
The proposed d9-THC limit of 10 ppm for CBD oil is difficult to achieve, given that many oils contain higher concentrations due to their natural composition. The 0,1 ppm limit for beverages is also highly stringent, with detection limits generally higher than this. Reaching these limits for food is also unrealistic and needs to be reconsidered,” regards.

Richard Sams, Ph.D & Ryan Belone, CCO – KCA Labs
“The proposed residual limit values ​​are extremely low and few laboratories worldwide are able to test these standards consistently. Additionally, environmental factors can cause CBD to convert into d9-THC, increasing its concentration in products. Given the complexity and cost of testing up to these limits, there is a high potential for fraud, with untested illegal products possibly containing much higher levels of THC,” claim.

Christopher Hudalla, Ph.D – ProVerde Laboratories
“The proposed limits for d9-THC are unattainable for most products. For example, the 0,1 ppm limit in food is not practically achievable and should be re-evaluated,” suggests Hudalla.

Martin Lee – CBD Project
“The near-zero THC limits proposed by the Japanese government do not benefit CBD users in the wellness market. These impractical limits prevent users from experiencing the full effects of CBD and pose unnecessary technical and financial challenges. It is unrealistic and impossible to completely eliminate THC from cannabis products and these regulations will only impede market growth,” says Lee.

Furthermore, the Japanese industry community, 'CBD Club', is calling for international opposition to Japan's proposed THC limit values ​​and plans to submit signatures and comments collected to the Ministry of Health, Labor and Welfare and other government bodies.

Conclusion

The THC residual limits proposed by the Ministry of Health, Labor and Welfare could have a devastating impact on the Japanese CBD market. The overly strict new standards not only restrict consumers' choices, but also degrade the quality of life for many people who depend on CBD to maintain their health and alleviate symptoms. Furthermore, policies that diverge significantly from international standards risk isolating Japan from the global market. It is imperative that the government establishes viable, scientifically based regulations now to ensure the sustainable growth of the Japanese CBD market and to protect the health of its citizens.
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*Editor's Note: This article was written especially for CannaReporter® by Takuya Aiuchi, founder of Japan's leading CBD information platform, “CBD Library“, who owns the copyright. Translated into Portuguese and edited by Laura Ramos.