Can block a launchJapanBeauty & personal care

Japan sorts the shelf into two legal classes

Japan’s Pharmaceuticals and Medical Devices Act separates cosmetics from a second class of quasi-pharmaceutical products, defined as items with mild effects on the human body used for certain listed purposes, and a person who intends to market a quasi-pharmaceutical product must obtain the approval of the Minister of Health, Labour and Welfare for each item.

Deodorant, anti-hair-loss and depilatory products cross a legal line in Japan that they do not cross in the United States, so a range that ships as one catalogue at home arrives as two regulatory workstreams with different lead times.

Exceptions and limits

Narrows thisArticle 61 of Japan’s Pharmaceuticals and Medical Devices Act requires a cosmetic’s immediate container to carry seven categories of information, and ingredient naming appears only as the names of ingredients the Minister designates, with anything further delegated to Ordinance of the Ministry of Health, Labour and Welfare.

MechanismDeodorant and anti-hair-loss are the listed purposes
The Act names the purposes that put a mild-acting product in the quasi-pharmaceutical class: preventing nausea or other discomfort, preventing bad breath or deodorising the body, preventing heat rash and sores, and preventing hair loss, promoting hair growth or removing hair.
Why the claim above is true. It does not limit it. Confidence 88 of 100.
Wrong if Article 2(2) is amended to remove deodorising or hair-loss prevention from the listed purposes, or the Ministry publishes a translation in which those purposes do not appear.
(a) products for preventing nausea and other discomfort, or those for preventing bad breath or deodorizing the body; (b) products for preventing heat rash, sores, etc.; (c) products for preventing hair loss, or those to promote hair growth or remove hair
Cite as omr:jp:some-cosmetics-are-quasi-pharmaceuticals#which-purposes-cross-the-line
ThresholdThe list is not closed, the Minister can extend it
The same definition ends with a third limb covering products used for pharmaceutical purposes that the Minister of Health, Labour and Welfare designates, so the boundary of the class is set by ministerial designation and not only by the purposes written into the statute.
The claim above holds only on one side of this boundary. Confidence 80 of 100.
Wrong if Article 2(2) is amended to remove the ministerial designation limb, or the Ministry states that no products have been designated under it.
(iii) products used for purposes provided in item (ii) or (iii) of the preceding paragraph (excluding those set forth in the preceding two items) which are designated by the Minister of Health, Labour and Welfare.
Cite as omr:jp:some-cosmetics-are-quasi-pharmaceuticals#the-minister-can-add-to-the-list

88 of a possible 97Tier A, primary document or measured outcome. Nothing at this tier is allowed past 97, however good it looks.

Verified August 5, 2026Rechecked every 365 days, next by August 5, 2027.

Constraint

Held since August 5, 2026A rule, law or policy that limits what you may do or say. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.

This entry is wrong if

Article 2(2) is amended to remove those purposes from the quasi-pharmaceutical class, or Article 14 is amended so that quasi-pharmaceutical products no longer require per-item marketing approval.

Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.

Evidence

Tier Aregulation
Ministry of Justice, Japan (Japanese Law Translation): Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
(2) The term “quasi-pharmaceutical products” as used in this Act refers to the following items, which have mild effects on the human body: (a) products for preventing nausea and other discomfort, or those for preventing bad breath or deodorizing the body; (b) products for preventing heat rash, sores, etc.; (c) products for preventing hair loss, or those to promote hair growth or remove hair
The Japanese original reads ２この法律で「医薬部外品」とは、次に掲げる物であつて人体に対する作用が緩和なものをいう。 The published English is the Ministry of Justice’s translation and the site does not present it as authoritative, which is why this claim is capped below the tier-A ceiling.
Read 2026-08-05 · Open government · page hash a01b624828ba
Tier Aregulation
Ministry of Justice, Japan (Japanese Law Translation): Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Article 14 (1) A person who intends to market pharmaceuticals (excluding pharmaceuticals with specified standards designated by the Minister of Health, Labour and Welfare), quasi-pharmaceutical products (excluding quasi-pharmaceutical products with specified standards designated by the Minister of Health, Labour and Welfare) or cosmetics which contain components specified by the Minister of Health, Labour and Welfare must obtain approval from the Minister of Health, Labour and Welfare for each such item.
Read 2026-08-05 · Open government · page hash a01b624828ba

History

v1createdAugust 5, 2026
Initial entry from primary regulator text outside the United States, read 2026-08-05.
v1createdon a caveatAugust 5, 2026
Initial entry from primary regulator text outside the United States, read 2026-08-05.
v1createdon a caveatAugust 5, 2026
Initial entry from primary regulator text outside the United States, read 2026-08-05.

Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.

japan
pmd-act
quasi-drug
market-entry
compliance
beauty

Cite this entry

“Japan sorts the shelf into two legal classes”, The Orbt Market Index 0.1.0, entry omr:jp:some-cosmetics-are-quasi-pharmaceuticals, retrieved September 9, 2026, https://tryorbt.com/markets/entry/jp--some-cosmetics-are-quasi-pharmaceuticals. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "Japan sorts the shelf into two legal classes," Orbt Market Index, entry omr:jp:some-cosmetics-are-quasi-pharmaceuticals, verified August 5, 2026, https://tryorbt.com/markets/entry/jp--some-cosmetics-are-quasi-pharmaceuticals.

@misc{orbt-jp-some-cosmetics-are-quasi-pharmaceuticals,
  title        = {Japan sorts the shelf into two legal classes},
  author       = {{Orbt}},
  year         = {2026},
  doi          = {10.5281/zenodo.22679129},
  note         = {The Orbt Market Index 0.1.0 (dataset DOI 10.5281/zenodo.22679129), entry omr:jp:some-cosmetics-are-quasi-pharmaceuticals. Verified 2026-08-05},
  howpublished = {\url{https://tryorbt.com/markets/entry/jp--some-cosmetics-are-quasi-pharmaceuticals}},
  license      = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}

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