Is zhike fruit peel oil FDA-compliant for the US market?
For the US market compliance splits by end use. Flavour use: bitter orange peel oil (Citrus aurantium L.) is covered by 21 CFR §182.20 as a GRAS natural flavouring substance family and holds FEMA GRAS 2823 — zhike lots destined for flavour work are declared under that bitter-orange entry with supporting COA/GC data (maturity caveat as in the food-use FAQ applies). Cosmetic/fragrance use: the oil itself is not subject to pre-market FDA approval, but finished products fall under MoCRA — facility registration and product listing with the FDA, plus serious-event reporting — obligations that sit with the US manufacturer/marketer; we support them with full ingredient and batch documentation.
General: no medicinal claims are made or permitted; if a customer positions the oil as a dietary ingredient or drug component, a completely different regulatory path applies and must be confirmed before ordering. HTS 3301.29.51.50 'Other' MFN 0% (broker confirmation recommended).
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This article was published on 2026-09-29, and last updated on 2026-09-29. The article will be continuously updated.
