The Japanese government has released long-awaited guidance on THC limits for CBD products, enabling brands hoping to launch into the market to begin devising their strategies.
In May, 2024, Japan officially launched a public comment period for draft legislation meant to regulate the country’s emerging cannabis and CBD industries.
While the Ministry of Health, Labour and Welfare (MHLW) has made some minor changes to the initially opposed limits, they still represent the strictest in the world.
Dr Yuji Masataka, MD, Japan’s first specialist in medical cannabis, told Business of Cannabis these strict limits could still significantly impact the industry as it is rolled out.
Late last year, Japan made a major step towards cannabis reform after approving a bill to amend its 75-year-old Cannabis Control Act.
After passing the bill in November, 2023, the Japanese authorities launched a public comment period and got to work on ironing out the details of these reforms.
The initial proposals for THC limits in CBD products proposed severe restrictions, raising numerous concerns that the industry would therefore be dominated by isolate-based products, that the entourage effect would be done away with, and that CBD prices would remain high.
At the time, Dr Masataka suggested this would ‘make parallel imports of products difficult, potentially keeping CBD product prices high’.
He added: “Cannabis products are characterised by their diversity. Stricter THC standards will homogenise products, leading to the loss of the entourage effect.”
The suggested limits were as follows:
Now, after receiving a swathe of public comments, many of which warned against these strict limits and the impact they could have on the industry, the government has released new guidance on their proposed thresholds.
In response to these concerns, some adjustments have been made to the draft:
Dr Masataka explained that the threshold for raw materials, including isolate powder, have now been raised from the initially proposed 1ppm, to 10ppm.
While this represents a tenfold increase, and is a ‘significant step in the right direction’, it remains the strictest limit in the world and will do little to negate the concerns of the industry.
Notably, the MHLW states that they plan to launch a clinical study ‘to ensure that patients with intractable epilepsy can continue to use products containing cannabis-derived ingredients’.
With such trace amounts of THC permitted, there are concerns around the ability of current testing labs to be able to detect them without investing in High-Performance Liquid Chromatography (HPLC) but also a Mass Spectrometer (MS) equipment.
This, explained Dr Masataka, would ‘complicate the process and lead to increased costs’ of testing, and unnecessarily ‘raise product prices’ given that trace amounts of THC do not present any health risks.
Furthermore, products like broad-spectrum or vape products would struggle to comply with the new regulations, forcing a shift towards isolate products or synthetic CBD.
In turn, this would lead to a reduction in the efficacy of CBD products and impact potential market growth.
As is being seen in markets across the world, it could also encourage the proliferation of synthetic cannabinoid products, which technically do not contain any THC, but still have intoxicating properties. This could be seen as a ‘self inflicted’ issue by the MHLW.
Given the concerns around testing capabilities, it could also lead to fraudulent component analysis certificates being issued, and it would be ‘virtually impossible’ for the government to conduct spot checks on all products on the market, making the regulations ineffective.
Patients using CBD products are also concerned about these new proposals, and have launched a petition calling for a review which has now received over 35,000 signatures.
Dr Yuji Masataka, MD, is a graduate of the Faculty of Medicine, Kumamoto University. After meeting medical cannabis specialist Dr Jeffrey Hergenrather in California in 2016, he decided to become Japan’s first specialist in medical cannabis. In 2017, while working in the Department of Neurology at Kumamoto University, he, as Representative Director, established the nonprofit organisation Green Zone Japan, which aims to raise awareness about medical cannabis. Currently, he also holds the position of Vice Chairman at the Japanese Society of Clinical Cannabinoid Research.
Dr Masataka also acts as a Key Opinion Leader for Astrasana Japan Co. Ltd., providing support to create a progressive and inclusive landscape in Japan, where CBD products are not only widely accepted but also celebrated for their potential health benefits and recognised as a valuable market opportunity.
The post Japan Issues Update on New THC Limits in CBD Products Which Remain ‘Strictest in the World’ appeared first on Business of Cannabis.
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In May, 2024, Japan officially launched a public comment period for draft legislation meant to regulate the country’s emerging cannabis and CBD industries.
While the Ministry of Health, Labour and Welfare (MHLW) has made some minor changes to the initially opposed limits, they still represent the strictest in the world.
Dr Yuji Masataka, MD, Japan’s first specialist in medical cannabis, told Business of Cannabis these strict limits could still significantly impact the industry as it is rolled out.
What happened?
Late last year, Japan made a major step towards cannabis reform after approving a bill to amend its 75-year-old Cannabis Control Act.
After passing the bill in November, 2023, the Japanese authorities launched a public comment period and got to work on ironing out the details of these reforms.
The initial proposals for THC limits in CBD products proposed severe restrictions, raising numerous concerns that the industry would therefore be dominated by isolate-based products, that the entourage effect would be done away with, and that CBD prices would remain high.
At the time, Dr Masataka suggested this would ‘make parallel imports of products difficult, potentially keeping CBD product prices high’.
He added: “Cannabis products are characterised by their diversity. Stricter THC standards will homogenise products, leading to the loss of the entourage effect.”
The suggested limits were as follows:
- Oil (10mg/kg = 0.001% = 10ppm)
- Beverages (0.10mg/kg = 0.00001% = 0.1ppm)
- Others (e.g., food) (1mg/kg = 0.0001% = 1ppm)
Now, after receiving a swathe of public comments, many of which warned against these strict limits and the impact they could have on the industry, the government has released new guidance on their proposed thresholds.
In response to these concerns, some adjustments have been made to the draft:
- Oil/Powder (10mg/kg = 0.001% = 10ppm)
- Aqueous solutions (0.10mg/kg = 0.00001% = 0.1ppm)
- Others (e.g., food) (1mg/kg = 0.0001% = 1ppm)
Dr Masataka explained that the threshold for raw materials, including isolate powder, have now been raised from the initially proposed 1ppm, to 10ppm.
While this represents a tenfold increase, and is a ‘significant step in the right direction’, it remains the strictest limit in the world and will do little to negate the concerns of the industry.
Notably, the MHLW states that they plan to launch a clinical study ‘to ensure that patients with intractable epilepsy can continue to use products containing cannabis-derived ingredients’.
Issues remain
With such trace amounts of THC permitted, there are concerns around the ability of current testing labs to be able to detect them without investing in High-Performance Liquid Chromatography (HPLC) but also a Mass Spectrometer (MS) equipment.
This, explained Dr Masataka, would ‘complicate the process and lead to increased costs’ of testing, and unnecessarily ‘raise product prices’ given that trace amounts of THC do not present any health risks.
Furthermore, products like broad-spectrum or vape products would struggle to comply with the new regulations, forcing a shift towards isolate products or synthetic CBD.
In turn, this would lead to a reduction in the efficacy of CBD products and impact potential market growth.
As is being seen in markets across the world, it could also encourage the proliferation of synthetic cannabinoid products, which technically do not contain any THC, but still have intoxicating properties. This could be seen as a ‘self inflicted’ issue by the MHLW.
Given the concerns around testing capabilities, it could also lead to fraudulent component analysis certificates being issued, and it would be ‘virtually impossible’ for the government to conduct spot checks on all products on the market, making the regulations ineffective.
Patients using CBD products are also concerned about these new proposals, and have launched a petition calling for a review which has now received over 35,000 signatures.
Dr Yuji Masataka, MD, is a graduate of the Faculty of Medicine, Kumamoto University. After meeting medical cannabis specialist Dr Jeffrey Hergenrather in California in 2016, he decided to become Japan’s first specialist in medical cannabis. In 2017, while working in the Department of Neurology at Kumamoto University, he, as Representative Director, established the nonprofit organisation Green Zone Japan, which aims to raise awareness about medical cannabis. Currently, he also holds the position of Vice Chairman at the Japanese Society of Clinical Cannabinoid Research.
Dr Masataka also acts as a Key Opinion Leader for Astrasana Japan Co. Ltd., providing support to create a progressive and inclusive landscape in Japan, where CBD products are not only widely accepted but also celebrated for their potential health benefits and recognised as a valuable market opportunity.
The post Japan Issues Update on New THC Limits in CBD Products Which Remain ‘Strictest in the World’ appeared first on Business of Cannabis.
Continue reading...