How is this schisandra berry oil treated under US FDA rules?
Schisandra berry oil is marketed in the US as a botanical dietary supplement ingredient, following the DSHEA framework rather than GRAS food-flavor classification.
US FDA Status
| Application | Status | Detail |
|---|---|---|
| Dietary supplement ingredient | Compliant | Sold as a botanical (Schisandra chinensis) extract/oil under DSHEA |
| Food flavoring (GRAS) | Not claimed | Schisandra berry oil does not carry a FEMA GRAS number; flavor use would require individual evaluation |
| New Dietary Ingredient (NDI) | Assessed per case | Pre-1994 US marketing history of schisandra supports grandfathered status; NDI filing support provided where needed |
| cGMP | Compliant | Produced under food/dietary-supplement cGMP-aligned management (21 CFR 111/117) |
| Labeling | Support | Supplier disclosure, batch COA, and English labeling documents provided |
- US buyers typically use the oil in tinctures, softgels, and functional blends where schisandra is a well-known adaptogen
- We provide an English allergen/purity statement and any documentation required for FDA establishment inspection
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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.
