US FDA and DSHEA Requirements for Importing Herbal Ingredients from India: A Buyer's Compliance Guide

Q: What is the difference between DSHEA and cGMP for Indian herbal ingredient suppliers?

DSHEA (the Dietary Supplement Health and Education Act of 1994) is the US federal law that establishes the regulatory framework for dietary supplements - defining what they are, what claims may be made, and placing responsibility for safety on manufacturers and distributors rather than requiring FDA pre-market approval. cGMP (current Good Manufacturing Practice) under 21 CFR Part 111 is the manufacturing quality standard issued under DSHEA that specifies how dietary supplement ingredients must be manufactured, tested, and documented. For Indian herbal ingredient buyers, the practical implication is this: DSHEA defines the legal framework, cGMP defines the operational quality requirements your Indian supplier must meet. Requesting evidence of cGMP-compliant manufacturing - typically a third-party audit against 21 CFR Part 111 or equivalent - is the appropriate minimum for US-bound supply.

Q: What is an NDI notification and which Indian herbal ingredients require one?

An NDI (New Dietary Ingredient) notification is a premarket safety submission required under DSHEA for any dietary supplement ingredient not marketed in the United States before October 15, 1994. The notification must be submitted to FDA at least 75 days before the ingredient is introduced into interstate commerce. Most established Ayurvedic herbs - ashwagandha root, turmeric, moringa, tulsi, brahmi - have been marketed in the US since well before 1994 and are generally not NDIs in their standard forms. However, novel extracts, standardised concentrates at specifications not previously marketed, and ingredients combined in ways not previously sold may trigger the NDI requirement. If you are introducing an Indian herbal ingredient in a form or at a concentration not previously sold in the US supplement market, consult a US regulatory attorney or dietary supplement specialist to determine whether an NDI notification is required before launch.

Q: Does California Proposition 65 apply to Indian herbal ingredient imports?

Yes, if your product is sold in California or shipped to California - including through online marketplaces. Proposition 65 requires businesses to provide a warning when a product exposes California consumers to chemicals listed by the state as carcinogens or reproductive toxins at levels above specified safe harbor thresholds. For herbal ingredients, the primary concern is naturally occurring heavy metals - lead, cadmium, and arsenic - which are present in soil and absorbed by plants during cultivation. The lead safe harbor level under Prop 65 is 0.5 micrograms per serving per day, which is approximately 1,000 times stricter than FDA daily intake guidance. Many herbal powders and root extracts exceed this threshold at standard serving sizes even when heavy metal levels are well within FDA limits. Ensure your Indian supplier''s COA includes ICP-MS tested heavy metal data at the lot level, and assess Prop 65 exposure at your intended serving size before launch in California.

Q: What should I require from an Indian herbal ingredient supplier to meet US cGMP requirements?

At minimum, require the following from any Indian supplier serving the US market: FDA facility registration number and confirmation it is current; a third-party cGMP audit report against 21 CFR Part 111 from a recognised inspection body such as NSF, SGS, Bureau Veritas, or Intertek; a batch-specific Certificate of Analysis from a NABL-accredited laboratory covering botanical identity, active constituent assay, heavy metals (lead, arsenic, cadmium, mercury) to ICH Q3D or USP limits, pesticide residue screening, and microbial limits including absence of Salmonella and E. coli; and a Material Safety Data Sheet in GHS format. If the ingredient is organic, also require USDA NOP certification from a USDA-accredited Certifying Agent - Indian NPOP certification is not equivalent to USDA NOP and does not satisfy US organic requirements.

The United States is the largest single market for Indian herbal and Ayurvedic ingredient exports. American supplement brands, contract manufacturers, private label formulators, and functional food producers collectively represent the most commercially significant buyer base for Indian botanical ingredients globally. Ashwagandha, turmeric, moringa, tulsi, boswellia, and a range of other Ayurvedic actives have moved from specialty health food stores into mainstream US supplement brands and mass retail channels.

For US buyers sourcing these ingredients from India, the regulatory environment is distinct from every other market. The United States operates under a framework established by the Dietary Supplement Health and Education Act of 1994 (DSHEA) that places primary responsibility for ingredient safety, labeling accuracy, and manufacturing quality on manufacturers and distributors - not on the FDA through pre-market approval. Understanding this framework, and knowing what it requires from your Indian supplier, is the difference between a US-compliant supply chain and one that carries unquantified regulatory risk.

This guide covers the US regulatory requirements that directly affect international buyers sourcing herbal ingredients from India: the DSHEA framework, cGMP manufacturing standards, FDA facility registration, New Dietary Ingredient (NDI) notifications, and California Proposition 65. It is written for procurement managers, regulatory affairs teams, and brand founders making their first or ongoing India sourcing decisions.

The DSHEA Framework: What It Means for Ingredient Buyers

The Dietary Supplement Health and Education Act of 1994 is the federal law that defines what dietary supplements are, how they may be labeled and marketed, and what safety obligations manufacturers and distributors carry.

The most consequential feature of DSHEA for ingredient buyers is this: dietary supplements do not require FDA pre-market approval before they are sold. The FDA does not review or approve a dietary supplement formulation before it enters the US market. Responsibility for ensuring that a dietary supplement is safe, properly manufactured, and accurately labeled rests with the manufacturer and distributor.

This structure means that the quality and compliance of your Indian ingredient supplier is your responsibility to verify - the FDA will not have done it for you. When the FDA does act, it acts post-market: through inspections, warning letters, import alerts, and recalls. At that point, the liability for a non-compliant supply chain falls on the US brand, not on the Indian exporter.

Three practical implications for buyers:

First, you cannot assume that an Indian supplier’s existing customer list - even one that includes well-known US brands - confirms the supplier is compliant with US requirements. Other buyers may have conducted their own verification; they may also not have.

Second, FDA facility registration (covered below) is a notification requirement, not an inspection-based approval. A registered facility has notified the FDA of its existence; it has not been inspected or certified by the FDA.

Third, the documentation burden sits with you. If your ingredient supplier provides a substandard Certificate of Analysis, an undated GMP certificate, or inadequate identity testing, and your finished product is subsequently recalled or subject to an FDA warning letter, your defense rests on the documentation you collected and reviewed before the problem occurred.

cGMP: Current Good Manufacturing Practice Under 21 CFR Part 111

Current Good Manufacturing Practice (cGMP) regulations for dietary supplements are codified at 21 CFR Part 111. They were finalized by the FDA in 2007 and apply to all manufacturers, packagers, labelers, and distributors of dietary supplements marketed in the United States - including foreign manufacturers whose products are imported into the US market.

21 CFR Part 111 establishes mandatory requirements for:

Physical plant and equipment - manufacturing premises must be designed and maintained to prevent contamination and ensure product integrity. Equipment must be cleaned, maintained, and calibrated on documented schedules.

Quality control operations - a qualified person must be designated responsible for quality control. There must be written procedures for all manufacturing operations, and those procedures must be followed and documented.

Components, packaging, and labels - all incoming dietary ingredient components must be verified for identity before use. For botanical ingredients, identity verification must be conducted on every shipment, not just on the first order from a supplier.

Master manufacturing records and batch production records - for every dietary supplement produced, a master manufacturing record (MMR) must exist specifying the formula, manufacturing steps, and specifications. A batch production record (BPR) must document the production of each specific batch against the MMR.

Laboratory operations - laboratory testing must be conducted using validated methods and calibrated equipment. Results must be documented and retained.

Testing finished products - each batch of finished dietary supplement must be tested to verify identity, purity, strength, and composition before it is distributed.

What this means for your Indian supplier: An Indian herbal ingredient manufacturer supplying the US market should be able to demonstrate cGMP-compliant manufacturing through a third-party audit against 21 CFR Part 111 or an equivalent standard. The most commonly recognised third-party certification for this purpose in the US market is NSF/ANSI 173 (Dietary Supplements) or an audit conducted by a recognised inspection body such as SGS, Bureau Veritas, Intertek, or TUV SUD against 21 CFR Part 111 scope.

Note that FDA facility registration (see below) is not evidence of cGMP compliance. Many registered facilities have never been inspected by the FDA. A current, scope-appropriate third-party cGMP audit report is the meaningful compliance signal - not registration alone.

FDA Facility Registration

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Food Safety Modernization Act (FSMA), any facility outside the United States that manufactures, processes, packs, or holds food or dietary supplement ingredients for consumption in the United States must register with the FDA.

This registration requirement applies to your Indian herbal ingredient suppliers. It is managed through the FDA’s registration portal and must be renewed biennially in even-numbered years between October 1 and December 31.

What registration confirms: That the facility has notified the FDA of its existence, location, and the type of food or supplement ingredients it handles. Registration gives the FDA the ability to inspect the facility and, if necessary, suspend registration (which effectively bars the facility from exporting to the US).

What registration does not confirm: That the FDA has inspected the facility, reviewed its manufacturing practices, or determined that it is compliant with cGMP or any other standard. A facility can be registered and simultaneously non-compliant with 21 CFR Part 111.

How to verify: Request the supplier’s FDA facility registration number and verify it against the FDA’s public registration database at www.fda.gov/food/registration-food-facilities-title-21-cfr-part1-subpart-h. An Indian supplier that cannot provide a current FDA facility registration number is not eligible to export ingredients to the US market.

FDA import alerts: If an Indian supplier’s facility or product category has been subject to an FDA import alert, shipments from that facility may be detained without physical examination at the US port of entry. Import alerts are publicly searchable on the FDA website. Before committing to a new Indian supplier for US-bound supply, check whether any import alerts are in force for that facility or product.

New Dietary Ingredient (NDI) Notifications

Under DSHEA, a New Dietary Ingredient (NDI) is defined as any dietary supplement ingredient not marketed in the United States before October 15, 1994. For any product containing an NDI, the manufacturer or distributor must submit a premarket safety notification to the FDA at least 75 days before the ingredient is introduced into interstate commerce.

What the NDI notification contains: The notification must identify the ingredient (including its Latin binomial name for botanicals), describe the dietary supplement in which it will be used, state the intended conditions of use, and provide a history of use or other safety evidence demonstrating that the ingredient is reasonably expected to be safe under the conditions described.

Which Indian herbal ingredients are NDIs: Most established Ayurvedic herbs and botanical extracts that have been marketed in the US supplement market since the 1980s and early 1990s are not NDIs. Ashwagandha root, turmeric rhizome, moringa leaf, tulsi, brahmi (Bacopa monnieri), shatavari, boswellia, and the majority of classic Ayurvedic ingredients in standard forms were present in the US dietary supplement market before October 15, 1994 and are generally not subject to the NDI notification requirement.

Where NDI questions arise: The NDI boundary becomes relevant when an Indian ingredient is sold in a form or at a specification not previously marketed in the US. A novel extract with a new standardisation method, a concentration significantly higher than what was previously sold, a new delivery format (for example, a liposomal encapsulation of an existing extract), or a combination of ingredients in a ratio not previously sold - any of these may constitute an NDI requiring notification.

The FDA publishes a list of submitted NDI notifications, which can be searched by ingredient name. If your Indian supplier claims their product does not require an NDI notification because it is an established ingredient, verify this against the FDA’s published notification list and, for new formats or high-potency specifications, consult a US regulatory attorney or dietary supplement specialist before commercial launch.

Practical implication: This is not a supplier-side requirement - the NDI notification is submitted by the US manufacturer or distributor, not the Indian ingredient exporter. However, your Indian supplier should be able to provide documentation of the ingredient’s history of use in the US market if you need to support an NDI safety assessment.

California Proposition 65 and Heavy Metals

California Proposition 65 - formally the Safe Drinking Water and Toxic Enforcement Act of 1986 - is a state-level regulation that requires businesses to provide a warning when a product exposes California consumers to chemicals listed by the California Office of Environmental Health Hazard Assessment (OEHHA) as carcinogens or reproductive toxins above defined safe harbor thresholds.

For herbal ingredient buyers, Proposition 65 is a material compliance consideration because heavy metals - lead, cadmium, and arsenic - are naturally occurring in soil and are absorbed by plants during cultivation. Dried herbal powders and root extracts routinely contain trace levels of these metals even when produced by fully cGMP-compliant Indian manufacturers with rigorous quality controls.

The lead threshold: The Prop 65 safe harbor level for lead is 0.5 micrograms per serving per day for reproductive toxicity. This is approximately 1,000 times stricter than FDA daily intake guidance for lead. A herbal root powder served at a standard supplement dose may exceed the Prop 65 lead safe harbor even when its heavy metal levels are well within FDA and USP limits. In 2025 alone, more than 5,000 Notices of Violation were filed against consumer brands under Prop 65, with heavy metals in herbal powders, protein powders, and supplement ingredients among the most frequently cited categories.

The practical implication for India sourcing: Prop 65 does not make Indian herbal ingredients non-compliant or unsellable in California. It creates a labeling requirement - a Prop 65 warning on the product - when exposure exceeds the safe harbor threshold at the intended serving size. Many US supplement brands selling herbal ingredients in California carry Prop 65 warnings as standard practice. What Prop 65 requires of your supplier is high-quality, ICP-MS tested heavy metal data at the lot level, so you can accurately calculate per-serving exposure and determine whether a warning is required.

What to require from your Indian supplier for Prop 65 purposes: A batch-specific Certificate of Analysis with ICP-MS tested lead, cadmium, arsenic, and mercury results expressed in micrograms per gram (or parts per million). This gives you the data needed to calculate per-serving exposure against Prop 65 safe harbor thresholds at your specific serving size. Generic or estimated heavy metal values are not sufficient - you need lot-specific quantitative data from an accredited laboratory.

Note that Prop 65 applies to products sold in California regardless of where the manufacturer or brand is based. If your product is sold through online channels that ship to California, Prop 65 compliance applies. If you sell through distributors who may sell into California, Prop 65 compliance applies.

FSMA Foreign Supplier Verification Program

The Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP), fully effective for dietary supplement ingredients, requires US importers to perform risk-based activities to verify that their foreign suppliers are producing food and dietary supplement ingredients in a manner that meets US safety standards.

FSVP applies to the US importer - the person in the US who purchases or consigns the imported ingredient. It does not apply to the Indian supplier directly, but it creates documentation obligations that flow back to your supplier verification activities.

What FSVP requires of US importers:

Identify a qualified individual responsible for FSVP compliance
Determine known or reasonably foreseeable hazards with each imported ingredient
Evaluate the risk posed by the ingredient and the supplier’s performance
Conduct supplier verification activities appropriate to the identified risk
Take corrective action when a supplier does not meet US food safety standards
Maintain records of all FSVP activities

What this means in practice: The documentation you collect from your Indian supplier - GMP certificates, audit reports, Certificates of Analysis, FDA facility registration - is not just quality assurance best practice. Under FSVP, it is a regulatory obligation. FSVP records are subject to FDA inspection and must be retained for a minimum of two years.

For herbal ingredients assessed as presenting a hazard requiring a supplier verification activity, onsite audits of the Indian manufacturing facility are the most rigorous verification method and may be required depending on the risk assessment outcome.

What to Require from Your Indian Supplier for the US Market

Consolidating the requirements above, a US-bound Indian herbal ingredient supplier should be able to provide the following as standard documentation:

Regulatory standing:

FDA facility registration number (current, verifiable in the FDA database)
FSSAI Central License (domestic food safety baseline)

GMP and quality systems:

Third-party cGMP audit report against 21 CFR Part 111 (or NSF/ANSI 173 certification) from a recognised inspection body - SGS, Bureau Veritas, Intertek, NSF, or TUV SUD - with current validity and scope covering the ingredient category being supplied
Quality manual or summary of documented SOPs for receipt, testing, manufacturing, and release

Per-shipment documentation:

Batch-specific Certificate of Analysis from a NABL-accredited laboratory covering: botanical identity (HPLC or TLC), active constituent assay at declared specification, moisture content, heavy metals (lead, arsenic, cadmium, mercury) by ICP-MS to ICH Q3D or USP limits, pesticide residue multi-residue screening, microbial limits (total aerobic count, yeast and mould, absence of Salmonella spp. and E. coli)
Material Safety Data Sheet in GHS 16-section format
Phytosanitary certificate issued by NPPO India prior to shipment departure
Certificate of Origin

For organic supply to the US:

USDA NOP certification from a USDA-accredited Certifying Agent - Indian NPOP certification is not equivalent to USDA NOP and cannot be used to support US organic claims

For Prop 65 compliance:

ICP-MS heavy metal data at lot level expressed in micrograms per gram or parts per million, enabling per-serving exposure calculation at your intended serving size

The US Market and India: A Supply Relationship Worth Getting Right

The United States represents the single largest commercial opportunity for Indian herbal ingredient exporters, and Indian manufacturers serving the US market have made significant investments in FDA-compliant manufacturing infrastructure over the past decade. GMP-certified Indian facilities with validated analytical laboratories, third-party audit credentials, and established US customer relationships exist across the Ayurvedic and botanical extract supply base.

For US buyers, the challenge is identifying which Indian suppliers have genuinely built US-compliant quality systems - and which rely on documentation that looks complete on the surface but does not meet the standard a US regulatory inspection would expect. The gap between these two supplier types is wide, and the commercial and regulatory consequences of getting this wrong fall on the US brand, not on the Indian exporter.

Getting this right from the start - with structured supplier qualification, documentation review, and appropriate verification activities under FSVP - creates a supply chain that is not only compliant but defensible: one that can withstand an FDA inspection, a Prop 65 enforcement action, or a quality non-conformance without significant operational disruption.

Sourcing herbal ingredients from India for the US market? Ayris Global works with verified Indian producers who maintain FDA-compliant quality systems and can provide the documentation US buyers require. Contact our sourcing team to discuss your ingredient requirements, or visit our For Buyers page for more information.

Frequently Asked Questions

Does my Indian herbal ingredient supplier need to be registered with the US FDA?

Yes. Any foreign facility that manufactures, processes, packs, or holds dietary supplement ingredients for US consumption must register with the FDA under the Bioterrorism Act and FSMA. Registration is a notification requirement, not an inspection-based approval. Request your supplier’s FDA facility registration number and verify it in the FDA’s public registration database. A supplier unable to provide a current registration number is not eligible to export ingredients to the US market.

What is the difference between DSHEA and cGMP for Indian herbal ingredient suppliers?

DSHEA is the US federal law establishing the dietary supplement regulatory framework - defining what supplements are, what claims may be made, and placing safety responsibility on manufacturers rather than requiring FDA pre-market approval. cGMP under 21 CFR Part 111 is the manufacturing quality standard issued under DSHEA, specifying how dietary supplement ingredients must be manufactured, tested, and documented. For Indian suppliers, cGMP compliance is demonstrated through third-party audit against 21 CFR Part 111 or NSF/ANSI 173, not through FDA registration alone.

What is an NDI notification and which Indian herbal ingredients require one?

An NDI notification is a premarket safety submission required for any dietary supplement ingredient not marketed in the US before October 15, 1994, submitted at least 75 days before commercial launch. Most established Ayurvedic herbs in standard forms were marketed in the US before 1994 and are not NDIs. The requirement becomes relevant for novel extracts, new standardisation specifications, or formulation formats not previously sold in the US market. If uncertain, consult a US regulatory attorney before launch.

Does California Proposition 65 apply to Indian herbal ingredient imports?

Yes, if the finished product is sold in California or shipped there through any channel including online marketplaces. The Prop 65 lead safe harbor is 0.5 micrograms per serving per day - approximately 1,000 times stricter than FDA guidance. Many herbal powders and root extracts exceed this threshold at standard serving sizes even with FDA-compliant heavy metal levels. Require ICP-MS tested, lot-specific heavy metal data from your Indian supplier to calculate per-serving exposure and determine whether a Prop 65 warning is required.

What should I require from an Indian herbal ingredient supplier to meet US cGMP requirements?

At minimum: FDA facility registration number (current and verifiable); third-party cGMP audit against 21 CFR Part 111 from NSF, SGS, Bureau Veritas, Intertek, or TUV SUD; batch-specific COA from a NABL-accredited laboratory covering identity, active constituent assay, ICP-MS heavy metals, pesticide residues, and microbial limits; GHS-format MSDS; and phytosanitary certificate. For organic supply, USDA NOP certification is required - Indian NPOP certification does not satisfy US organic requirements.

Ayris Global connects international buyers with verified Indian producers of botanical extracts, Ayurvedic actives, herbal powders, and nutraceutical ingredients. To discuss US-market sourcing requirements, contact us at sourcing@ayrisglobal.in or visit our For Buyers page.