Exporting Supplements from India: US, EU, UK and GCC Rules and Halal Explained

Supplements made in India can be exported, but each destination regulates them differently, so a product compliant in India may need reformulating or relabelling before it ships. The US regulates them as dietary supplements with Supplement Facts labelling and requires food facility registration, the EU and UK treat them as food supplements with novel food and claims controls, and GCC countries generally require product registration, often alongside Halal certification.

Importers, overseas brands and Indian founders expanding abroad all face the same question: what has to change for each market? An export-ready nutraceutical manufacturer in India can manufacture to your specification and prepare documents, but market access depends on the formula, the label, the claims and the importer of record. This guide gives a general overview. Regulations change, so confirm the current position with your importer or a regulatory adviser in each market before you commit to production.

The principle: design for the strictest market first

Ingredient lists, permitted forms, maximum levels, labelling formats and claims all vary between markets. If you plan to sell in several regions, it is usually more efficient to design a formula that meets the strictest relevant rules and then adapt labels, rather than build separate formulas later. Discuss target markets at the brief stage of custom formulation.

United States

• Category. Products are regulated as dietary supplements under US food law, not as drugs, provided they meet the definition and make no disease claims.
• Facility registration. Foreign facilities that manufacture, process, pack or hold food for US consumption must be registered with the US FDA as food facilities and renew registration on the FDA's schedule. Harrods Health's facility is US FDA registered. Registration is not an FDA approval of products.
• Manufacturing practice. Dietary supplements are subject to US current good manufacturing practice requirements, and importers have their own supplier verification obligations.
• Labelling. Labels use a Supplement Facts panel in a defined format, alongside statement of identity, net quantity, ingredient list and responsible party details.
• Ingredients. Some ingredients not previously marketed in the US may require a new dietary ingredient notification before sale.
• Claims. Structure/function statements are allowed with a mandatory disclaimer and notification to the FDA, but disease claims are not. Claims must be substantiated.
• Shipping. Food imports generally require prior notice to the FDA before arrival.

European Union

• Category. Food supplements are regulated under EU food law, with a dedicated framework setting permitted vitamins and minerals and their forms. Maximum levels for many substances are still set nationally.
• Novel foods. Ingredients without a significant history of consumption in the EU before the reference date need novel food authorisation before use. This catches some botanicals and extracts familiar in India, so check each one.
• Notification. Many member states require the importer or brand to notify the national authority before a supplement is placed on the market.
• Claims. Only authorised nutrition and health claims may be used; claims for many botanicals remain unresolved, which limits what can be said.
• Labelling. Food information rules apply, plus supplement-specific mandatory statements, in the language of each country of sale.

United Kingdom

Great Britain has its own supplement, novel food and claims regime following its exit from the EU, broadly similar in structure but with separate registers and authorisations. Northern Ireland has its own arrangements. Treat the UK as a separate market.

GCC countries

Gulf Cooperation Council markets each run their own systems, although standards are increasingly harmonised. Common features include:

• Classification. Authorities decide whether a product is a food, a health or supplement product, or a medicine, based on ingredients, dose and claims. Classification determines the registration route.
• Product registration. Most supplements need registration or listing by a local importer or agent before sale, with a dossier of formula, labels, specifications and manufacturer documents.
• Labelling. Arabic labelling is generally required, often alongside English.
• Halal. Halal certification is expected, and in some cases required, for products containing animal-derived ingredients, and is widely requested by buyers for all products. The certifying body must be recognised in the destination country.
• Climate. Hot transit and storage conditions make packaging and stability especially important.

Harrods Health's facility is Halal certified, and products are assessed individually for Halal suitability.

Other markets: Africa and South-East Asia

Many African and South-East Asian markets require product registration with a national regulator, local labelling and an in-country importer or registrant. Requirements, timelines and classification rules differ widely, so engage a local partner early. Halal certification is important in several South-East Asian and African markets.

Comparing the main markets

Area	US	EU and UK	GCC
Category	Dietary supplement	Food supplement	Food or health product, by classification
Facility requirement	FDA food facility registration	Food business rules via the importer	Manufacturer documents in registration dossier
Product pre-approval	Generally no, except new ingredients	Notification in many states; novel foods need authorisation	Registration or listing usually required
Label format	Supplement Facts panel	Food information rules plus supplement statements	Arabic labelling, local requirements
Claims	Structure/function with disclaimer	Authorised claims only	Reviewed during registration
Halal	Buyer driven	Buyer driven	Widely expected

Export documents and logistics

• Commercial invoice, packing list and certificate of origin.
• Certificates of analysis for each batch, plus product specifications.
• Copies of manufacturer licences and certifications, such as FSSAI, GMP, ISO and Halal.
• Health or free sale certificates where the destination requires them.
• Labelling that matches the registered or notified product exactly.

Our fulfilment and export service packs, documents and dispatches to export ports, and our quality certifications page lists what we hold. Claims rules differ by market too; see what supplement brands can and cannot say.

Common export pitfalls

• Printing labels before the importer confirms local requirements.
• Using an Indian label with only a sticker added, when the market expects full local labelling.
• Assuming an ingredient permitted in India is permitted everywhere.
• Copying Indian marketing claims into markets with authorised claims lists.
• Shipping with too little remaining shelf life for the importer or retailer.
• Underestimating registration time in markets that need product approval before sale.

How Harrods Health supports exporters

We manufacture nutraceuticals and health supplements in-house under an FSSAI licence for nutraceuticals, in a facility that is also ISO certified, GMP-compliant, Halal certified, AYUSH licensed and US FDA registered. We offer ready and custom formulas, packaging and label design, samples before you order, a single account manager and dispatch to warehouses or export ports. Market registration and claims approval remain the responsibility of the brand owner or importer.

Frequently asked questions

Can supplements made in India be sold in the US?

Yes, if the facility is registered with the US FDA, the product meets the dietary supplement definition, ingredients are acceptable, labels follow US rules and claims are compliant. The importer also has its own obligations.

Does FDA registration mean a product is FDA approved?

No. Food facility registration is a requirement for the facility. It is not an approval or endorsement of any product.

Do I need Halal certification to sell in the GCC?

Halal is widely expected and may be required for products with animal-derived ingredients. Check with your importer and the destination authority.

Why might an Indian formula need changing for the EU?

Some ingredients may be novel foods in the EU, permitted vitamin and mineral forms differ, and maximum levels and claims rules vary, so formulas and labels often need adapting.

Planning an export range? Talk to our private label supplement manufacturing team.