Market coverage
US FDA
11 markets your formula is checked against · 30+ underlying jurisdictions and 20+ frameworks feeding those verdicts
What does The Molecule Lab check against US FDA?
Every ingredient and formula lookup is checked against US FDA using the 6 regulatory datasets listed below, read directly at query time rather than from a cached summary. A substance with no entry in these datasets is reported as not assessed, not as permitted.
- Datasets
- 6
- Market key
- fda
Authority
U.S. Food and Drug Administration (FDA)
Framework
FD&C Act as amended by MoCRA (2022)
Notification
Two separate duties under MoCRA: a facility that manufactures or processes a cosmetic for US distribution registers with FDA (§607(a)); the responsible person named on the label separately submits a product listing (§607(c)). A small-business exemption exists for facilities/responsible persons under $1M in average annual US cosmetic sales, but it does not apply to eye-area, injectable, internal-use, or long-duration appearance-altering products (§612).
Labeling
The responsible person's name — the manufacturer, packer, or distributor identified on the label under FD&C Act §609(a) or FPLA §4(a) — must appear on the product, and is the same identity that carries the product-listing obligation above.
Read the full FDA facility registration guide →| Dataset | Table |
|---|---|
| FDA Prohibited Substances | fda.prohibited |
| FDA Restricted Substances | fda.restricted |
| FDA Permitted Color Additives | fda.color_additives |
| California Prop 65 Warning List | fda.prop65 |
| CA Safe Cosmetics Act (CSCA) | fda.csca |
| FDA OTC Monograph Active Ingredients | fda.otc_monograph |
This list is US FDA's own datasets, not the complete set of data that can affect a verdict here. Cross-market hazard and assessment data — SVHC, IFRA, REACH Annex XVII, allergens, Prop 65 in the US — can also apply to a formula check without being one of US FDA's own tables. See every source behind a verdict →
Recent changes in US FDA
No recorded regulatory changes for US FDA yet.