market-intelligence
Entering the USA Market: A Guide for Indian Herbal Ingredient Suppliers
28 June 2026
The United States is the largest dietary supplement market in the nine covered in this series, and on the regulatory side, it is also one of the more predictable. The Dietary Supplement Health and Education Act of 1994 has governed herbal ingredients for three decades without the kind of structural overhaul New Zealand attempted and abandoned, or the Novel Food uncertainty that complicates the EU. What makes the USA the most complicated market in this series is not the FDA framework. It is the tariff situation, which has changed legal basis twice in the past year and carries a hard, dated expiration that falls within weeks of this guide’s publication.
This guide separates the two clearly: a stable regulatory framework that Indian suppliers can plan around with confidence, and a trade and tariff picture that genuinely cannot be stated as a fixed fact and must be verified at the time of any quote.
The Regulatory Framework: DSHEA and the FDA
Herbal ingredients sold in the United States are regulated as dietary supplements, a distinct legal category created by DSHEA in 1994 and sitting under the FDA’s broader food authority rather than its drug authority. This structural choice shapes everything else about how the US market works.
The FDA does not pre-approve dietary supplements or the ingredients in them. There is no listing system comparable to Australia’s AUST L, no notification-and-wait period comparable to the EU’s Novel Food process for most botanicals already in the food supply. Manufacturers and distributors are legally responsible for ensuring their products are not adulterated or misbranded before marketing, and the FDA’s primary enforcement tool is post-market action: inspection, warning letters, import detention, and in serious cases, seizure or injunction.
The one major exception is the New Dietary Ingredient notification. An ingredient that was not present in the US food supply before October 1994 in a chemically unaltered form is classified as an NDI, and the manufacturer or distributor must submit a safety notification to FDA at least 75 days before introducing a product containing it into interstate commerce. The FDA has continued refining this process through 2025 and into 2026, including new guidance on NDI Master Files that allow an ingredient supplier to file safety documentation once and have multiple downstream customers reference it, rather than each customer re-submitting the same safety case. For an Indian supplier whose ingredient already has an established US market history, this is rarely a live issue. For genuinely novel extracts or unusual plant parts, it is the single most important compliance question to resolve before a first shipment, not after.
Manufacturing for dietary ingredients and finished supplements is governed by Current Good Manufacturing Practice regulations under 21 CFR Part 111, covering facility conditions, testing of raw materials for identity and purity, batch documentation, and supplier verification. Foreign facilities supplying the US market are expected to operate to equivalent standards, and US buyers will typically ask for evidence of this as part of supplier qualification.
Labeling for a finished supplement requires a Supplement Facts panel, a statement of identity, full ingredient declaration, country of origin, manufacturer or distributor information, and the mandatory disclaimer that FDA has not evaluated the product’s claims and that it is not intended to diagnose, treat, cure, or prevent disease. For B2B ingredient supply rather than finished retail product, much of this labeling burden sits with the US-based buyer who formulates and sells the finished item, but the supplier should still provide complete, accurate documentation of botanical identity, plant part, and extraction method, since the buyer cannot label correctly without it.
Sourcing for the US market? Ayris Global connects qualified US buyers with GMP-certified Indian producers and supports NDI status checks, FDA facility registration verification, and full compliance documentation for dietary supplement and food-grade botanical supply. Request samples
The Foreign Supplier Verification Program and Facility Registration
Two procedural requirements sit underneath the labeling and safety framework and are easy for a first-time exporter to miss entirely, because neither shows up on a finished product label.
FDA facility registration is required for foreign facilities that manufacture, process, pack, or hold food or dietary ingredients for the US market, and this registration must be actively renewed during each even-numbered year. A shipment from an unregistered facility, or one whose registration has lapsed, can be detained at the port of entry regardless of the product’s actual quality or compliance. This is a pure paperwork failure mode, and it is entirely preventable with a standing renewal calendar.
The Foreign Supplier Verification Program, FSVP, places the formal verification burden on the US importer rather than the foreign supplier, requiring the importer to confirm that imported food, including dietary ingredients, is produced under conditions meeting US safety standards. In practice, this means a US buyer will ask an Indian supplier for documentation, facility audit history, and testing records that support the importer’s own FSVP file, not as an optional courtesy but as a precondition the buyer needs to satisfy their own legal obligation. Suppliers who can produce this documentation proactively, rather than scrambling when asked, materially shorten the buyer’s onboarding timeline.
The Tariff Situation: The Least Stable Picture in This Series
This is the section that needs the most careful reading, and the part of this guide most likely to be partially out of date by the time it is read, through no fault of the underlying research.
As of this guide’s publication in late June 2026, here is the documented sequence of events. In February 2026, the United States and India announced a framework reducing a prior reciprocal tariff rate on Indian goods from 25 percent to 18 percent, as part of an interim agreement intended as a step toward a broader Bilateral Trade Agreement. Before that 18 percent rate could take lasting effect, the US Supreme Court ruled on February 20, 2026 that the tariffs imposed under the International Emergency Economic Powers Act, the legal basis for the reciprocal tariff structure generally, were not authorized by that statute. The 18 percent India-specific rate, built on that same legal foundation, became moot as a result.
Within days, the administration invoked a different and considerably narrower legal authority: Section 122 of the Trade Act of 1974, which permits a temporary import surcharge of up to 15 percent to address balance-of-payments concerns, capped by statute at 150 days unless Congress acts to extend it. This Section 122 surcharge took effect February 24, 2026 at an initial 10 percent, was raised to the statutory maximum of 15 percent shortly after, and applies as a flat, country-uniform rate, meaning India faces the same surcharge as most other trading partners rather than a negotiated bilateral figure. This surcharge stacks on top of the ordinary MFN duty rate that applies to the product’s HTS classification, and the combined total is what actually lands on an invoice.
The critical fact for any sourcing decision made around the time of this guide’s publication: Section 122 has a hard statutory expiration of approximately July 24, 2026. Unlike the broader emergency tariff authority the Supreme Court struck down, the President cannot extend Section 122 unilaterally. Only Congress can do so, and as of this guide’s research, no extension legislation had been passed. Separately, the US Trade Representative initiated Section 301 investigations in March 2026 covering more than a dozen economies, India among them, examining manufacturing capacity and trade practice concerns, with a public comment period that closed in April 2026. Section 301, unlike Section 122, carries no statutory rate cap and no built-in time limit, and trade analysts widely view it as the administration’s likely mechanism for whatever tariff structure follows Section 122’s expiration.
Separately again, and on a longer and slower track, India’s Commerce Minister stated in late June 2026 that a comprehensive US-India Bilateral Trade Agreement has been substantially finalized in its broad terms, but explicitly will not be brought into force until India secures a tariff competitiveness advantage over named competing exporters, a condition tied to the legal and tariff mechanism the United States ultimately settles on after Section 122 expires.
What this means in practice: there is no single, stable tariff figure to quote for Indian herbal ingredients entering the United States right now, and any number in this paragraph should be treated as a snapshot, not a forecast. Suppliers and buyers should verify the current applicable rate directly through a customs broker or the published HTS schedule before finalizing any pricing that depends on the assumption.
A Genuinely Useful Exception: The Annex II Botanical Exemptions
Inside this otherwise unstable picture sits one specific, well-documented, and currently durable piece of good news for Indian botanical exporters.
The tariff structure includes an Annex II exemption list, a set of HTS-classified products excluded from the surcharge entirely because they are natural resources or agricultural inputs not produced domestically in sufficient quantity. This exemption list originated under the prior tariff framework and has carried forward into the current Section 122 regime without significant reduction for this category. A November 2025 update specifically added turmeric, ginger, and cinnamon to this exemption list, alongside coffee, tea, and various tree nuts, following direct advocacy from US natural products industry groups citing the absence of domestic supply for these botanicals.
Two items relevant to Indian herbal exporters, psyllium husk and Boswellia, sit in a related but distinct category, flagged for potential exemption specifically for countries with an active trade agreement with the United States, a condition India does not yet meet given the BTA’s current not-in-force status described above.
The important caveat, and the one most likely to trip up a supplier assuming the exemption applies automatically: eligibility is determined by HTS classification code, not by the product’s marketing name or common description. A raw, dried turmeric root and a standardized curcumin extract are different products under different HTS headings, and the extract does not automatically inherit the raw spice’s exemption simply because both are commonly called turmeric. Suppliers should confirm the exact HTS classification for their specific product form, ideally with the buyer’s customs broker, rather than assuming a favorable exemption carries across processing stages.
A Practical First-Order Checklist for USA Buyers and Suppliers
- Confirm FDA facility registration is current for the supplying facility before the first shipment, and build renewal into an even-numbered-year compliance calendar rather than handling it reactively.
- Determine NDI status early for any ingredient without an established US market history; an NDI notification has a 75-day minimum lead time before commercial introduction, which should be planned into any new-ingredient timeline, not discovered after a buyer asks.
- Be ready to support the buyer’s FSVP file with facility audit history, testing records, and identity documentation; this is a legal obligation on the importer, not an optional add-on, and proactive documentation shortens onboarding.
- Do not quote a fixed landed cost assuming today’s tariff rate will hold past July 24, 2026; confirm current Section 122, MFN, and any applicable Section 301 status directly with a customs broker at the time of quoting, not from this guide or any other static source.
- Check the exact HTS classification for the specific product form being shipped, raw, powdered, or extracted, before assuming an Annex II spice exemption applies; classification, not marketing description, controls eligibility.
- Treat the broader US-India Bilateral Trade Agreement as not yet operative for pricing purposes; it remains under negotiation with an explicit condition, stated by India’s own Commerce Minister, that it will not take effect until specific tariff competitiveness terms are met.
- Maintain complete botanical identity and extraction documentation even for raw ingredient supply, since the labeling and FSVP burden on the US buyer depends on accurate information the supplier is best positioned to provide.
Summary: What to Get Right
The United States offers Indian herbal ingredient suppliers the most established and predictable regulatory framework in this series. DSHEA has governed dietary supplements for three decades, the FDA does not pre-approve products, and the compliance burden centers on accurate labeling, GMP manufacturing, current facility registration, and an NDI notification process that is well-documented and rarely a surprise for ingredients with existing market history.
The tariff and trade picture is the opposite: the least stable in this series, having changed legal basis twice within the past year and carrying a hard statutory expiration that falls within weeks of this guide’s publication, with no settled successor mechanism. Inside that instability, one durable and specific advantage exists for a defined set of botanicals, including turmeric, ginger, and cinnamon, through an Annex II exemption that has survived the transition to the current tariff regime. Suppliers who separate the stable regulatory question from the genuinely unstable trade question, and who verify tariff status at the time of every quote rather than relying on a fixed figure, are positioned to navigate the largest and most complex market in this nine-market series without being caught by a number that changed since they last checked it.
Frequently Asked Questions
Does the FDA approve herbal ingredients before they can be sold in the United States?
No. The FDA does not pre-approve dietary supplements or their ingredients. Under DSHEA, manufacturers and distributors are responsible for evaluating their own products’ safety and labeling before marketing, and FDA’s authority is primarily post-market. The exception is a New Dietary Ingredient, which requires a safety notification at least 75 days before commercial introduction.
What is the current US tariff rate on herbal ingredients imported from India?
As of mid-2026, most Indian imports face a flat 10 to 15 percent Section 122 surcharge on top of the standard MFN duty rate, following the February 2026 Supreme Court ruling that struck down the prior tariff structure. This surcharge is scheduled to expire around July 24, 2026 unless Congress extends it. A separate, longer-term Bilateral Trade Agreement remains under negotiation and was not yet in force as of this guide’s publication. Confirm current status directly before quoting.
Are common Indian spices and botanicals like turmeric and ginger exempt from US tariffs?
Many are, through an Annex II exemption list. Turmeric, ginger, and cinnamon were added in a November 2025 update and that exemption has carried forward into the current regime. Eligibility depends strictly on HTS classification code, not marketing description, so an extract of an exempted raw spice may not automatically share the same exemption.
What labeling requirements apply to herbal ingredients sold as dietary supplements in the US?
Finished products need a Supplement Facts panel, a statement of identity, complete ingredient declaration, country of origin, manufacturer information, and the standard FDA disclaimer. For raw ingredient supply to a US formulator, labeling responsibility typically shifts to the buyer, but the supplier should still provide accurate botanical and processing documentation.
Does an Indian supplier need their own FDA registration to export herbal ingredients to the US?
Yes, in most cases. Foreign facilities supplying food or dietary ingredients to the US generally must register with FDA, renewed each even-numbered year, and comply with Foreign Supplier Verification Program requirements that place verification responsibility on the US importer. An unregistered facility can cause shipment detention regardless of product quality.
Further Reading: Entering the Australia and New Zealand Market: A Guide for Indian Herbal Ingredient Suppliers · Entering the EU Market: A Guide for Indian Herbal Ingredient Suppliers · GMP, ISO, FSSAI and Organic Certification for Indian Herbal Exports
Ayris Global connects qualified US buyers with verified, GMP-certified Indian producers of herbal extracts, Ayurvedic ingredients, and botanical powders, with full support for NDI status checks, FDA facility registration verification, and compliance documentation for dietary supplement and food-grade botanical supply. To discuss your sourcing requirements, contact our team at sourcing@ayrisglobal.in or visit our products page.
