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Japan Designates Three Dangerous-Drug Components as Designated Drugs, Ban Takes Effect Nov. 8

The step follows an expert panel’s finding that the substances pose likely psychoactive harms to public health.

Overview

  • The health ministry promulgated a ministerial ordinance on October 29 to classify three components found in so-called dangerous drugs as designated drugs, with prohibitions beginning November 8, 2025.
  • Once in force, non-medical manufacture, import, sale, possession and use of the listed substances and products containing them will be illegal.
  • The three substances were recommended for designation by the Pharmaceuticals and Medical Devices Council subcommittee on October 28, enabling an expedited process that omits public comments in urgent cases.
  • Violations carry penalties of up to three years’ imprisonment or a ¥3 million fine, rising to up to five years or ¥5 million when conducted as a business.
  • Separately, the ministry opened public comments from October 29 to November 27 on a draft to designate cannabinol (CBN), with its promulgation targeted for mid-December and enforcement 10 days after.