CBD companies serving the Japanese market are scrambling to line up suppliers of “THC-free” formulations in anticipation of strict rules kicking into effect before the end of the year.
Japan recently set maximum THC limits for CBD products and the raw materials used to make them. In keeping with Japanese post-WWII cannabis policy, the limits are among the strictest in the world. For CBD products, the threshold for THC content is set at 10mg/kg (= 0.001% = 10ppm) for oils and powders, and even stricter limits apply to aqueous solutions (0.10mg/kg = 0.00001% = 0.1ppm) and food products (1mg/kg = 0.0001% = 1ppm).
Those limits are at least 200 to 300 times stricter than the threshold in most other countries with established CBD regulations, which observe a 0.3% THC limit for all product categories. Japan’s approach to CBD regulation reflects a strong aversion to THC, even at trace levels, consistent with its post-WWII stance on cannabis, which has included some of the most conservative policies worldwide.
Industry pushback and delays
Stakeholders and consumers organized petitions and lobbied government officials following the announcement of the new rules earlier this year, but their efforts resulted only in a delay rather than substantive change, pushing the rules’ start date to mid-December from the originally scheduled October launch. Although there is widespread public interest in relaxing restrictions on CBD in Japan, regulatory bodies remain resolute in maintaining strict THC limits due to concerns over public health and cannabis control.
Unique challenges
The new THC limits create unique challenges for foreign CBD suppliers that have already established a market presence in Japan. Companies like PharmaHemp of Slovenia, Elixinol and CBDfx from the U.S., Endoca from Denmark, and Naturecan from the UK are some of the global players claiming to offer THC-free products. It will be interesting to see how those claims hold up against Japan’s insistence on transparency and rigorous compliance.
Japan’s strict standards demand third-party lab testing with zero tolerance for THC, and these requirements come at a time when past issues in the industry have raised concerns about certification credibility. Many certifications in the CBD sector have been found to be unreliable or outright fraudulent, posing a serious risk to brands.
For companies that do not meet Japan’s standards, the implications could include reputational damage, lost revenue, and possibly a forced exit from the Japanese market.
Adjustments ahead
Japanese regulators’ commitment to enforcing these strict standards highlights the risks for CBD companies entering or already operating in Japan. The rapid expansion of CBD’s popularity globally has led companies to diversify their supply chains and product formulations, but meeting Japan’s standards may require entirely new manufacturing practices and added costs. Industry observers are closely watching how these regulations will affect the Japanese market’s growth, and the competitive landscape may shift as only the most compliant brands remain viable.
For companies willing to invest in Japan’s regulatory demands, maintaining compliance could provide a competitive edge in a high-stakes market, reinforcing their credibility and commitment to quality.
‘Certified’ risky
The CBD industry has faced numerous issues with unreliable or fraudulent certifications, underscoring the need for stronger regulatory oversight, particularly related to THC content and product purity. Here are some notable examples:
Non-compliant THC Levels: Studies, like one from the Journal of the American Medical Association in 2017, revealed that nearly 70% of CBD products tested were mislabeled regarding their THC and CBD content. Some products contained THC levels above the legal limit despite being labeled as “THC-free,” raising compliance concerns.
Mislabeling and False “THC-Free” Claims: The U.S. Food and Drug Administration (FDA) has issued warnings to companies for labeling products as THC-free or containing specific CBD amounts, only to find through testing that the actual levels didn’t match. In 2019, the FDA issued warning letters to companies like Curaleaf for mislabeled THC and CBD amounts.
Undisclosed Contaminants: A study from Frontiers in Pharmacology reported that contaminants, including pesticides and heavy metals, were found in several products labeled as “pure” or “organic.” Diamond CBD, for example, was found in third-party testing to have synthetic cannabinoids and heavy metals in some products, despite claiming they were safe and natural.
“Lab Tested” Claims Without Verification: Some companies claim third-party testing as proof of quality but either conduct these tests in-house or use labs without proper accreditation. An investigation by NBC 6 South Florida in 2019 found that several products labeled as “THC-free” still contained THC. This highlighted a widespread issue where lab test results are manipulated or conducted by non-certified labs.
Fake or Inconsistent Lab Reports: There have been instances of CBD companies falsifying lab reports, sometimes editing old or unrelated reports to give the appearance of purity.