US FDA Cosmetic Compliance for Bulk Aromatic Ingredient Imports
The US FDA regulates cosmetic ingredients imported into the United States. With MoCRA (Modernization of Cosmetics Regulation Act) enacted in 2022, requirements for facility registration, adverse-event reporting, and ingredient labelling have tightened. For US-bound bulk aromatic ingredient shipments, here is the procurement-grade reference.
What MoCRA + FDA cosmetic compliance covers
MoCRA requires cosmetic-product manufacturers to register their facility with FDA, list cosmetic products and ingredients, report serious adverse events, maintain safety substantiation files, and comply with allergen-labelling requirements. As a bulk-ingredient supplier to US cosmetic manufacturers, our compliance pack supports the US-side QA team MoCRA obligations.
What we ship in the US FDA / MoCRA paperwork pack
- FDA Prior Notice (for food-flavour bound SKUs)
- INCI nomenclature on every cosmetic-grade ingredient
- CAS + EC number on COA
- Allergen identification — Section 605 cosmetic-allergen disclosure (where applicable)
- 21 CFR compliance reference for food-bound SKUs
- Pharmacopoeia-grade reference where applicable (USP / NF)
- Safety Data Sheet in 16-section format (OSHA-compatible)
- Heavy-metals panel on request (lead, arsenic, mercury, cadmium)
- Country-of-origin certificate
- GMP-aware production statement
US-bound SKU categories
| SKU category | FDA reference | Notes |
|---|---|---|
| Cosmetic carrier oils | 21 CFR Part 700 | INCI + allergen + CAS declared |
| Aromatic chemicals (cosmetic-grade) | 21 CFR Part 700 | INCI + EC number |
| Essential oils | 21 CFR Part 700 | Botanical INCI; cosmetic-grade COA |
| Food flavour (D-Limonene, etc.) | FEMA + FCC + 21 CFR Part 182 | FEMA-listed; food-grade certification |
| Pharmacopoeia-grade (USP/NF) | 21 CFR Part 211 | USP / NF compliance; pharma-grade COA |
| Topical OTC actives (menthol, camphor) | 21 CFR 341 | USP-grade default; OTC monograph compliance |
How US importers source from us
- Specify US destination + end-use (cosmetic / food / OTC) at RFQ stage
- List SKUs + intended end-product application
- Quote PDF includes FDA-relevant compliance pack overview
- PI confirmation triggers full FDA / MoCRA paperwork prep
- Dispatch includes country-of-origin certificate + INCI + allergen + 21 CFR-relevant COA
- FDA Prior Notice handled at our export-customs stage for food-bound SKUs
US FDA-compliant bulk RFQ in 4 working hours
List SKU + US end-use (cosmetic / food / OTC) + monthly volume. Quote PDF + FDA / MoCRA compliance pack reference back same working day.
Request quote + FDA pack →WhatsApp +91 98100 57471