In the US, botanicals sold as dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994, known as DSHEA. The FDA does not approve supplements before they go on sale, but the brand is responsible for safety, correct labelling and manufacturing to dietary supplement cGMP.
For a buyer sourcing raw herbs from India, the key duties are identity testing, contaminant control, supplier verification and honest labels. This is a general overview, not legal advice. Check with a US regulatory adviser for your product.
The main requirements
- cGMP: dietary supplement manufacturers must follow the FDA's current good manufacturing practice rules, which include testing to confirm the identity of each dietary ingredient.
- New dietary ingredients: an ingredient not marketed in the US as a supplement before 15 October 1994 may need a new dietary ingredient notification to the FDA before sale.
- Labelling: products need a Supplement Facts panel, the botanical name and plant part, and other required label elements.
- Claims: structure or function claims are allowed with the standard FDA disclaimer. Claims to treat or cure disease are not.
- Facility registration: foreign facilities that make, process or pack food for the US, including supplement ingredients, must register with the FDA.
- Imports: shipments need FDA prior notice, and importers have duties under the Foreign Supplier Verification Program (FSVP), with specific provisions for supplements.
What this means for your Indian supplier
Your supplier does not need FDA approval, but they do need a current FDA food facility registration if they process or pack the herb. Ask for the registration number and check it before shipping.
You will need documents that support your own cGMP and FSVP files. Ask for a specification, a certificate of analysis per lot, the botanical name and plant part, and the country and region of origin.
Identity testing is your responsibility under cGMP, even if the supplier tests too. Methods such as HPTLC, microscopy and macroscopic checks are commonly used for herbs. See what HPTLC is used for.
Contaminants and state rules
Federal rules do not set one heavy metal limit for supplements, but your product must not be adulterated. Many brands set limits based on USP guidance and on California's Proposition 65 warning levels. Our article on heavy metal limits in herbs explains how these fit together.
Pesticide residues are judged against EPA tolerances. Microbial limits usually come from your own spec or USP guidance.
Organic and other claims
If you label the supplement organic, the ingredient needs USDA NOP certification. Indian NPOP certificates are no longer recognised for the US. Kosher, halal and non-GMO claims depend on private certifiers your customer accepts.
Rules change, and the FDA updates guidance often. Check the current position on the FDA's dietary supplements pages before launch.
How we help
We check your supplier's FDA registration, gather the documents your FSVP and cGMP files need, and test each lot for identity and contaminants at NABL-accredited labs. We do not give legal advice, but we make sure the supply side is ready. Ask for a free sourcing review.