How Japan's First CBD Import Was Approved in 2013 —
And What It Took

There is a common assumption among international brands approaching the Japanese CBD market that the compliance pathway they use today — MHLW import notification, Japan-accredited CoA, component-based assessment — was always there waiting to be navigated. It was not. Before 2013, the pathway did not exist. What exists today was built through a single negotiation that took eighteen months and could have ended in several ways.

Japan in 2013: The Regulatory Void

Japan's Cannabis Control Act in 2013 was a plant-part statute drafted in 1948. It prohibited the possession, cultivation, and import of "cannabis" — defined primarily by reference to the plant's leaves, flowers, and roots. Hemp stalks and seeds were explicitly excluded from the definition, reflecting the traditional use of hemp fiber and hempseed oil in Japan.

CBD had not been contemplated when the Act was drafted. There was no regulatory position on CBD oil. No ministerial guidance. No precedent. When Asayake Inc.'s director SHIRASAKA Kazuhiko first raised the question with MHLW officials in 2012, the immediate response was not a legal opinion — it was a request to come back with documentation about what CBD actually was.

The Documentation Phase

The first year of the process was almost entirely about education. We prepared a comprehensive submission for MHLW covering: the science of cannabidiol, its distinction from THC, international research on safety and non-psychoactivity, manufacturing processes used by reputable producers, and the regulatory status in relevant international jurisdictions (US, UK, EU, Australia).

This was not a standard import application. There was no form for it. We were asking MHLW to develop a position on a compound that Japan's law had simply never addressed. The officials we worked with were diligent — they took the submission seriously, commissioned internal review, and engaged with it substantively. But the process had no defined timeline because no defined process existed.

The Critical Question: Which Part of the Plant?

The pivotal legal question was whether CBD oil extracted from hemp could be considered derived exclusively from the stalk and seed — the excluded parts — rather than from leaves and flowers. Hemp CBD extraction in 2013 was not the highly refined isolate production process common today. Whole-plant extraction methods were standard, and the legal basis for arguing that the resulting oil was "stalk-derived" required careful analysis of both the extraction process and the resulting product's composition.

We worked with the producer to document the extraction process in detail, establishing a clear chain from licensed industrial hemp cultivation through stalk extraction to finished CBD oil. The THC content of the finished oil was central — demonstrating that the product contained no meaningful psychoactive compound was essential to MHLW's assessment that the product did not fall within the intent of the Cannabis Control Act.

Eighteen Months to Yes

The formal approval — communicated via a written MHLW opinion rather than a standard import notification clearance, because no standard clearance process existed — came in 2013. The opinion established several principles that became the de facto framework for all subsequent CBD imports into Japan:

• CBD oil extracted from stalk-only hemp, with non-detectable THC, was not subject to the Cannabis Control Act's import prohibition
• Import was subject to food safety regulations under the Food Sanitation Act
• Product-specific review was required — the opinion did not create a blanket clearance for all CBD products
• The importer bore responsibility for ensuring ongoing compliance with the established parameters

This framework — product-specific, importer-responsible, food-law governed — is the direct ancestor of the import notification system that exists today. Every brand that has imported CBD into Japan since 2013 has been using infrastructure built on the foundation of that first approval.

What Changed Between 2013 and 2024

The eleven years between Asayake's first import and the December 2024 Cannabis Control Act revision saw the original MHLW opinion formalized, tested, and ultimately superseded by statute. Key milestones:

• 2016–2018: Rapid market growth. Multiple importers enter using the framework established by Asayake. MHLW begins developing more structured guidance.
• 2019: MHLW issues formal guidance on CBD product import requirements, formalizing the product-specific review process into documented procedure.
• 2021–2023: Consumer market reaches scale. Enforcement actions against non-compliant products begin. MHLW attention to THC residue levels increases.
• 2024: Legislative revision enacted. The component-based framework replaces the plant-part framework. What was MHLW administrative guidance becomes statute.

What This History Means for New Entrants Today

The existence of a structured import pathway for CBD in Japan is the result of a specific negotiation, conducted by a specific company, at a specific moment when Japan's regulatory officials were willing to engage seriously with the question. That negotiation created value that has benefited every brand that has entered the market since.

The pathway is now more defined than it was in 2013 — but it is also more demanding. The December 2024 residue limits, the CBN designation process, the Japanese laboratory testing requirement — these are the natural evolution of a regulatory framework that takes compliance seriously. Brands that approach Japan's market with the same level of preparation and documentation that Asayake brought to MHLW in 2012 will find the pathway navigable. Those that treat compliance as an afterthought will find it closed.