Is this valerian root oil FDA compliant for the US market?
Valerian (root and oil) has a long US regulatory history, but the rules differ by product type. The summary below covers the main use categories so you can choose the right compliance path.
US Compliance by Use
| Use | Status | Notes |
|---|---|---|
| Dietary supplement (valerian root) | ✓ Established | Valerian root has a long history as a dietary supplement ingredient; use in capsule/tablet forms is common (cGMP per 21 CFR 111 applies to the finished product) |
| Food flavouring (oil) | ✓ Possible | Valerian is listed among natural flavouring substances in 21 CFR 172.510 (natural flavourings and natural substances used in conjunction with flavours) — use at flavouring levels under GMP |
| Cosmetics / fragrance | ✓ Regulated as ingredient | INCI-based labelling; finished-product safety substantiation is the manufacturer's responsibility; IFRA limits apply to fragrance use |
| Therapeutic / sleep claims | ⚠ Restricted | 'Treats insomnia' etc. = drug claim; requires NDA or must be presented as a dietary supplement structure/function claim with proper disclaimers |
Key Points
- We provide the COA, GC-MS and botanical-origin documentation you need for your US customer file
- For dietary-supplement labelling, follow 21 CFR 101.36 (supplement facts) and avoid disease claims
- The finished-product manufacturer is responsible for cGMP (21 CFR 111 for supplements, 21 CFR 110 for food) and label compliance
- For fragrance use, keep concentrations within the latest IFRA limits and, where required, include the allergen declaration for the final product
Relate Products
This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
