Selling supplements in the US.
What you need to know.
The US is the largest supplement market in the world — and one of the most accessible for Indian manufacturers. Under DSHEA, most supplements don't require pre-market approval from the FDA. Here's how the framework works and what our documentation covers.
DSHEA: What it means for you.
No Pre-Market Approval Required
Under the Dietary Supplement Health and Education Act (DSHEA, 1994), dietary supplements do not require FDA pre-market approval. You are responsible for ensuring safety and truthful labelling — but you don't need FDA sign-off before going to market.
GMP Compliance is Mandatory
21 CFR Part 111 requires that all dietary supplements sold in the US are manufactured in compliance with Good Manufacturing Practices. Our facility holds GMP certification accepted by the FDA.
FDA Facility Registration
Facilities manufacturing supplements for the US market must register with the FDA every two years under FSMA. Your facility of record may be our manufacturing site in India or your warehouse in the US — your compliance advisor can confirm.
New Dietary Ingredients (NDIs)
If an ingredient was not marketed in the US before 15 October 1994, an NDI notification may be required. Most of our catalogue (ashwagandha, curcumin, spirulina, CoQ10) have long-standing US market history. We'll flag any NDI requirements during your discovery call.
What your US label must include.
Supplement Facts Panel
The US-specific equivalent of "Nutrition Facts" for supplements. Serving size, servings per container, and % Daily Value (where established) for all ingredients. Mandatory format specified in 21 CFR Part 101.
Identity Statement
A "statement of identity" — what the product is. "Ashwagandha Root Extract" or "CoQ10 Supplement." Must appear on the principal display panel.
Net Content Declaration
Count (capsules), weight (g), or volume (fl oz). Placed on the principal display panel.
Structure/Function Claims
Health claims must be accompanied by a mandatory disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Claims must be notified to FDA within 30 days of first marketing.
Directions for Use
How to take the product. Must be clearly stated. We provide a template based on the formulation.
Manufacturer / Distributor Details
Name, address, and country of manufacture must appear on the label. Typically your US business address as the brand.
What ships with every US order.
| Document | Purpose | Included |
|---|---|---|
| NABL-accredited CoA | Potency, purity, heavy metals, microbial, pesticides | ✓ Standard |
| GMP Certificate | 21 CFR Part 111 compliance evidence | ✓ Standard |
| MSDS | Customs clearance, warehousing | ✓ Standard |
| Certificate of Indian Origin | Customs / country of origin | ✓ Standard |
| Supplement Facts template | US label compliance (21 CFR Part 101) | ✓ Standard |
| FDA Disclaimer text | Structure/function claim compliance | ✓ Standard |
Ready to launch in the US market?
All our formulations are export-ready for the US. Book a discovery call to confirm your ingredient list and label before placing your first order.