Japan’s Ministry of Health, Labour and Welfare (MHLW) has begun accepting public comments on a proposal to classify cannabinol (CBN) as a designated drug, the first step toward treating the hemp derivative as a regulated narcotic.
If finalized, the rule could prohibit the sale, advertising, distribution, and import of CBN products nationwide, with ripple effects potentially reaching CBD and other hemp-derived cannabinoids. The regulation would affect only Japanese CBN imports; the country prohibits domestic harvesting of hemp flowers and production of cannabinoids.
The public comment period, which runs through Nov. 27, followed a late October meeting of the Pharmaceutical Affairs Council’s Designated Drugs Subcommittee.
‘Avoid purchase and use’
The ministry says CBN products present “a high likelihood of psychotoxicity,” and is already urging consumers to “avoid their purchase and use.”
“Because it can be difficult to differentiate CBN from products containing other cannabinoids, such as CBD, the Ministry of Health, Labor and Welfare is calling on both consumers and businesses to pay attention to safety and take appropriate action,” MHLW said in announcing the consultation.
If finalized, the order would restrict sales, distribution, advertising and import of CBN under the Pharmaceuticals and Medical Devices Act, with promulgation targeted for mid-December and effect 10 days later.
Why now
CBN’s profile rose quickly in Japan over the past two years as retailers promoted it as a sleep-support compound with “stronger-felt” effects than CBD. High-dose cookies, gummies and other ingestibles quickly spread across e-commerce and boutique wellness outlets.
Multiple Japanese-language reports this year referenced an incident involving a university student who consumed a cookie advertised as containing CBN and subsequently jumped from a second-story window (remaining uninjured); national press and broadcast outlets amplified broader concerns about “cannabis-like” edibles and sudden illness among consumers. While details remain under investigation, the coverage contributed to a sharper policy posture.
Trade associations have tried to get ahead of regulators. The Japan Cannabinoid Federation (JCF) and allied bodies issued position papers and voluntary guidance, and the National Cannabis Commerce & Industry Council (Zenmakyo) rolled out labeling and ingestion recommendations this year that call for restraint on dose and marketing. These efforts acknowledge reports of emergency transports suspected from overconsumption and flag ultra-high-dose edibles—yet they have not slowed the health ministry from acting.
CBN’s rise, CBD’s dilemma
CBN’s commercial pitch in Japan has leaned on “feel it” functionality—particularly for sleep—making it a convenient upgrade narrative from CBD. That framing, combined with the difficulty of analytically distinguishing CBN from CBD in end products, is central to MHLW’s current warning to businesses and consumers, the agency has said.
If the rule is finalized, CBN would be placed in the same category as controlled drugs in Japan. Commercial sales — including supplements, gummies and wellness products — would be prohibited. Only pharmaceutical companies could use CBN, and only if they apply for and receive a specific medical-use approval from the ministry. MHLW’s timeline envisions promulgation in mid-December, leaving a narrow runway for compliance after comments close Nov. 27.
Shift to ingredient rules
The move to control CBN as Japanese officials are transitioning from “plant-part” rules to ingredient-based controls pegged to measurable cannabinoids—especially delta-9 THC. Historically, Japan has allowed only stalks and seeds of hemp in products; flowers and leaves remain prohibited.
That framework is still the practical baseline for CBD, which must be derived from those non-flower parts. Customs and regulatory guidance repeat those constraints. But producers have worked around the limitations for years by simply labeling their products as having come from hemp stalks even though that is a practical impossibility.
Japan also enforces some of the strictest THC limits in the world. For CBD oils and powders, the threshold is 10 mg/kg (0.001% or 10 ppm), with even tighter limits for beverages and some foods—orders of magnitude below the 0.3% norms used in the U.S. and Europe. HempToday reporting in 2024 detailed how those caps forced distributors to hunt for ultra-low-THC inputs and re-engineer supply chains.
What’s next
Stakeholder submissions will test whether MHLW entertains managed-risk options such as dose ceilings and category restrictions, or proceeds with a blanket CBN designation. Either way, the ministry’s language—and the accelerated timetable—signal a crackdown that could cascade beyond CBN to other non-intoxicating hemp cannabinoids if differentiation and enforcement remain problematic.