Ayurvedic Contract Manufacturing for US Brands
FDA facility registration, DSHEA compliance, and the complete process for sourcing Ayurvedic and herbal supplements from India for the US market.
US supplement brands sourcing Ayurvedic or herbal products from India need a manufacturer that is WHO-GMP certified, whose facility is FDA-registered, and whose formulations and labeling comply with DSHEA requirements rather than India’s FSSAI claim structure. A compliant Indian manufacturer will guide you through both sets of requirements before production begins.
Key US Regulatory Requirements
DSHEA
The primary US federal framework for dietary supplements. No pre-market FDA approval required, but brands are responsible for safety, accurate labeling, and avoiding unapproved drug claims.
FDA Facility Registration
Any foreign facility exporting food or dietary supplements to the US must register with the FDA under FSMA/Bioterrorism Act requirements — separate from FSSAI or WHO-GMP.
21 CFR Part 111 cGMP
The US-specific current Good Manufacturing Practice regulation for dietary supplements, with its own documentation format US importers expect.
Labeling Requirements
US labels require a Supplement Facts panel, allergen declarations, and structure/function claim disclaimers, distinct from India’s format.
FSSAI vs FDA/DSHEA at a Glance
| Area | FSSAI (India) | FDA/DSHEA (USA) |
|---|---|---|
| Pre-market approval | License-based, category-dependent | No pre-market approval; self-affirmed |
| Facility requirement | FSSAI license (+WHO-GMP recommended) | FDA registration + 21 CFR Part 111 |
| Label format | FSSAI nutritional panel | Supplement Facts panel |
| New ingredient rules | FSSAI approved ingredient list | NDI notification for novel ingredients |
Step-by-Step: Exporting to the US
Confirm Manufacturer Credentials
WHO-GMP certification, FDA facility registration, and a US export track record.
Formulation & Ingredient Review
Confirm botanical ingredients are permissible; novel ingredients may require an NDI notification.
Sample & Lab Testing
Third-party COA covering heavy metals, microbial, and potency testing.
Label Finalization
Develop a US-compliant Supplement Facts panel and required disclaimers.
Production & Documentation
Bulk production under GMP with full batch records and COAs.
Export Shipment
Commercial invoice, packing list, Certificate of Origin, and Free Sale Certificate.
US Customs Clearance
Accurate Prior Notice filing is essential to avoid port delays or refusal.
Common Pitfalls US Brands Should Avoid
- Assuming FSSAI compliance equals US compliance — the two systems have different claim rules and formats.
- Skipping Prior Notice filing — missing this causes port delays or refusal.
- Using unapproved health claims — traditional-use framing may not meet DSHEA’s standards.
- Not verifying FDA registration is current — it must be renewed biennially.
- Underestimating lead time for novel ingredients — factor in extra time for NDI review.
Does my Indian manufacturer need FDA registration?
Can Ayurvedic products be sold as dietary supplements in the US?
What’s the difference between WHO-GMP and US cGMP?
How long to set up a supplement import pipeline?
Request an Export Capability Sheet
WHO-GMP certified, FDA-registered manufacturing partner supplying US, European & Middle Eastern supplement brands.
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