Can block a launchSouth KoreaUnited StatesBeauty & personal care

A Korean plant is a US facility under MoCRA

A Korean plant that manufactures or processes cosmetics distributed in the United States falls inside the FDA’s definition of a facility, which is written around where the product is sold rather than where the plant stands.

Contract manufacturing in Korea does not put you outside the US registration regime; it puts your manufacturer inside it.

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

Verified August 4, 2026Rechecked every 180 days, next by January 31, 2027.

Constraint

Held since December 18, 2023A 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

Find FDA guidance stating that establishments located outside the United States are excluded from the section 607 facility registration requirement.

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
U.S. Food and Drug Administration: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Facility: any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States
The definition is verbatim tier A. Reading it as covering overseas plants is ours, so confidence sits below the tier-A ceiling.
Read 2026-08-04 · Public domain · page hash 8cc8da80f378

History

v1createdAugust 4, 2026
Initial entry from primary regulator text, read 2026-08-04.

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.

mocra
registration
manufacturing
market-entry

Cite this entry

“A Korean plant is a US facility under MoCRA”, The Orbt Market Index 0.1.0, entry omr:us:mocra-facility-definition-covers-overseas-plants, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--mocra-facility-definition-covers-overseas-plants. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "A Korean plant is a US facility under MoCRA," Orbt Market Index, entry omr:us:mocra-facility-definition-covers-overseas-plants, verified August 4, 2026, https://tryorbt.com/markets/entry/us--mocra-facility-definition-covers-overseas-plants.

@misc{orbt-us-mocra-facility-definition-covers-overseas-plants,
  title        = {A Korean plant is a US facility under MoCRA},
  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:us:mocra-facility-definition-covers-overseas-plants. Verified 2026-08-04},
  howpublished = {\url{https://tryorbt.com/markets/entry/us--mocra-facility-definition-covers-overseas-plants}},
  license      = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}

For a deck, a brief or a chat.

Free to quote, cite and act on. Not to resell or redistribute — the sources ask that of us, and each one’s terms are named. Machine-readable: entries.json carries this record under the id omr:us:mocra-facility-definition-covers-overseas-plants, with the same evidence and falsifier.

Published free, as reference, without warranty. This is not legal, regulatory, customs, tax or investment advice, and it is not a substitute for reading the primary document, which every record here names, dates and links, precisely so that you can.

We derive from public sources and we do not independently audit them. Where a source says its own records are unverified, that carries through to us. What we do promise is that every figure is recomputed from stored rows, every claim publishes the observation that would overturn it, and every correction goes on the public log. If something here is wrong, tell us and it changes in the open.

Orbt is not affiliated with, endorsed by or acting for U.S. Food and Drug Administration. They are cited as sources. Go and read them directly — they are more complete than we are, and they are linked from every record that rests on them.

This entry is wrong if

Evidence

History

Cite this entry

Read next