How does this litsea cubeba oil comply with FDA requirements for the US market?
For the US market, this litsea cubeba oil is supplied as a GRAS flavouring substance (FEMA 3846) and meets FCC 12 for food-chemical use, both recognised under the US regulatory framework. For cosmetics and personal care, the oil is used as a fragrance ingredient under FDA labeling rules (INCI name LITSEA CUBEBA FRUIT OIL). The batch is released to the appropriate spec accordingly.
FDA / US Compliance Summary
| Item | Status |
|---|---|
| Food flavouring | FEMA 3846 — GRAS reference; FCC 12 monograph |
| Food additives | Used as a flavouring substance, not a food additive requiring pre-market approval |
| Cosmetics | INCI LITSEA CUBEBA FRUIT OIL; ingredient list per 21 CFR 701 |
| GMP | Produced under GMP conditions with batch traceability |
| Documentation | COA, GC-MS, MSDS (OSHA/GHS), allergen statement for cosmetics |
| Import support | FDA Prior Notice data and product description provided for customs |
- The US cosmetic allergen disclosure (MoCRA) is supported by our allergen declaration data where required
- We do not make therapeutic claims; the oil is an ingredient for formulators and must be handled per SDS
- For food import, we provide the FEMA reference and specification so your broker can clear it smoothly
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This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
