Expensive to get wrongUnited StatesBeauty & personal care

Serious adverse events report in 15 business days

A responsible person must report serious adverse events associated with a cosmetic product in the United States to FDA within 15 business days, and include a copy of the retail label.

You need a US-hours intake process that can move in under three weeks before you have a single customer.

97 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

FDA publishes a reporting window other than 15 business days for serious adverse events.

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)
Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product.
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
adverse-events
compliance
operations

Cite this entry

“Serious adverse events report in 15 business days”, The Orbt Market Index 0.1.0, entry omr:us:mocra-serious-adverse-event-15-days, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--mocra-serious-adverse-event-15-days. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "Serious adverse events report in 15 business days," Orbt Market Index, entry omr:us:mocra-serious-adverse-event-15-days, verified August 4, 2026, https://tryorbt.com/markets/entry/us--mocra-serious-adverse-event-15-days.

@misc{orbt-us-mocra-serious-adverse-event-15-days,
  title        = {Serious adverse events report in 15 business days},
  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-serious-adverse-event-15-days. Verified 2026-08-04},
  howpublished = {\url{https://tryorbt.com/markets/entry/us--mocra-serious-adverse-event-15-days}},
  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-serious-adverse-event-15-days, 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