How is this storax balsam oil treated under US FDA regulations?
In the US market, storax balsam oil is recognized as a flavoring substance under FEMA GRAS 3036 and handled as a fragrance ingredient under IFRA; it is not a dietary-supplement ingredient in common use and is not subject to FDA food-additive approval as such.
US Regulatory Status
| Framework | Status | Note |
|---|---|---|
| FEMA GRAS 3036 | Flavoring substance | Storax (Liquidambar spp.) — recognized flavoring material for food/flavor use |
| FDA 21 CFR | Flavoring/adjunct | Used in food flavoring per FEMA GRAS basis; no independent food-additive petition needed for flavoring uses |
| Cosmetic Ingredient Review (CIR) | Cosmetics | Assessed within balsamic resins group; used in cosmetics as fragrance component |
| FDA DSHEA (dietary supplement) | Not typical | Storax oil is not a common dietary-supplement ingredient; not marketed as a supplement |
| IFRA / RIFM | Fragrance | IFRA Standard applies; RIFM monograph reviewed (skin sensitization data for cinnamyl alcohol & derivatives) |
| TSCA | Chemical inventory | Listed as naturally occurring substance; inventory status confirmation available on request |
- For flavor use, FEMA GRAS 3036 serves as the self-affirmation basis; we provide the FEMA number on the spec sheet
- For cosmetics, the finished formula must respect fragrance allergen declaration under FDA (21 CFR 700.3) when required by labeling practice
- Not for use as an unapproved drug ingredient — any TCM claims are limited to the China regulatory framework (ChP) and must not be made on US consumer products
- Documentation (spec, SDS, GC-MS) is prepared in English for US customs and buyer QA review
Relate Products
This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
