Importing herbal ingredients into the US centres on the FDA and on the importer’s responsibilities. This is a practical overview for US importers sourcing botanicals from India. It is general guidance, not legal advice: confirm the current rules for your product with your customs broker and the FDA.
Who carries the obligation?
The US importer of record carries most of the regulatory responsibility. The exporter (A.R.T International) supplies the goods, the Certificate of Analysis and the standard export documents. For the baseline documents any import needs, see our general import guide.
The FDA frameworks to know
| Area | What to check |
|---|---|
| FSVP | Foreign Supplier Verification Program (under FSMA): the importer verifies suppliers against US safety standards. The importer holds this duty. |
| Prior Notice | FDA generally requires Prior Notice for food imports before arrival, usually filed by your broker. |
| Facility registration | Food facilities in the supply chain may need FDA registration. Confirm what applies to your product. |
| Dietary supplements | DSHEA with cGMP under 21 CFR Part 111 for finished supplements. |
| Cosmetics use | MoCRA (Modernization of Cosmetics Regulation Act) for cosmetic products. |
| Plant material | Certain plant materials may need USDA/APHIS permits. |
The intended use decides which framework governs: the same botanical can be a food, a supplement ingredient or a cosmetic ingredient with different obligations. Pin down the use and the COA first.
How we support US importers
We supply to your written specification with a COA on every lot, plus the standard export documents (commercial invoice, packing list, certificate of origin, and a phytosanitary certificate where required). We support your FSVP by providing specifications and lot documentation. Send our export desk your ingredient, intended use and details and we will confirm what we can provide. See also the EU and GCC guides.
Frequently asked questions
Who is responsible for US import compliance?
The US importer carries most of the obligation, including FDA requirements such as the Foreign Supplier Verification Program (FSVP) for food. The exporter supplies the goods, the COA and standard export documents. We provide the documentation a US importer typically needs; confirm the full set with your customs broker.
What is FSVP?
The Foreign Supplier Verification Program is an FDA requirement under FSMA that makes the US importer responsible for verifying that foreign suppliers meet applicable US safety standards. Your importer of record manages FSVP; we support it by supplying specifications and a COA.
Do herbal ingredients need FDA Prior Notice?
FDA generally requires Prior Notice for food (including many botanical) imports before they arrive. Your customs broker or filer usually submits it. Confirm whether your specific product and use require it.
How are herbal dietary supplements regulated in the US?
Dietary supplements are regulated under DSHEA with cGMP requirements (21 CFR Part 111). We supply ingredients to your specification with a COA; the finished-product compliance and labeling are the importer or brand’s responsibility.
Specifications vary by crop, season and grade. For current lot specifications, sennosides or lawsone levels, MOQ and pricing to your destination, ask our export desk for a live COA.