Expensive to get wrongUnited StatesBeauty & personal care

“Hypoallergenic” means whatever the seller wants

FDA states that no Federal standards or definitions govern the use of the term “hypoallergenic,” that it means whatever a particular company wants it to mean, and that manufacturers using it are not required to submit any substantiation to FDA.

A sensitive-skin positioning built on this word rests on nothing a regulator will back, which matters most in the one category where the buyer is choosing on the promise of not reacting.

95

95 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.

Taboo

Held since October 18, 2000What causes offence or backlash here. 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 issues a definition or a substantiation requirement for “hypoallergenic” in cosmetic labelling.

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

  1. Tier Aregulation

    U.S. Food and Drug Administration: “Hypoallergenic” Cosmetics

    There are no Federal standards or definitions that govern the use of the term “hypoallergenic.” The term means whatever a particular company wants it to mean.

    Read 2026-08-05 · Public domain · page hash f64917ef0793

History

  1. v1created

    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.

  • labelling
  • marketing-claims
  • hypoallergenic
  • sensitive-skin
  • taboo
  • beauty

Cite this entry

““Hypoallergenic” means whatever the seller wants”, The Orbt Market Index 0.1.0, entry omr:us:hypoallergenic-has-no-federal-standard, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--hypoallergenic-has-no-federal-standard. Dataset: https://doi.org/10.5281/zenodo.22679129

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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:hypoallergenic-has-no-federal-standard, with the same evidence and falsifier.

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