Supplement Labelling Requirements and Compliance in USA | India | UAE | Europe

If you're planning to export supplements or scale globally, labeling isn't just a formality—it's your frontline defense.

In the USA, one missing FDA-required warning can get your product pulled. In India, a non-compliant AYUSH label might delay your FSSAI approval for months. And in the UAE or EU? Forget multilingual packaging or unapproved health claims—they simply won’t make it to shelves.

This guide breaks down supplement labeling requirements across USA, India, UAE, and Europe. We’ll cover what’s legally required, what varies country to country, and what exporters must know to avoid costly setbacks.

Looking to stay compliant, build trust, and expand globally? Start by fixing what’s on your label.

Why Supplement Labelling is Important?

If you're launching or exporting a supplement brand, accurate labelling isn't optional, it's essential.

From consumer trust to regulatory compliance, your label acts as a legal and ethical contract. It’s not just design, it’s documentation.

Here’s why getting your supplement labelling right is mission-critical:

Ensures Consumer Safety and Transparency

Your label communicates vital information: ingredients, dosage, allergens, usage instructions, and storage. It helps consumers make informed health decisions — and protects your brand from liability.

For instance, dietary supplement compliance in the USA requires a Supplement Facts panel, proper warnings and disclaimers, and allergen listings. In India, FSSAI nutraceutical labelling mandates functional classification and clear usage directions. Missing or incorrect details can trigger consumer harm, fines, or recalls.

Facilitates Regulatory Clearance Across Markets

Each region has its own regulatory framework, and label compliance is often the first barrier to entry.

• In the USA, FDA supplement labeling requires a standard format with business info, net content, and a disclaimer for structure/function claims.
• FSSAI regulations in India include bilingual labelling, specific nutrient claims, and dosage instructions.
• In Europe, the nutrition and health claims regulation managed by EFSA is one of the most rigorous worldwide.
• The UAE’s ESMA labelling laws require Arabic translation, country-of-origin disclosure, and strict ingredient limits.

Not following supplement label laws by country can result in port holds, product rejection, or long-term bans.

Boosts Export Readiness and Brand Legitimacy

A compliant label ensures smoother customs clearance, retail listing approvals, and global distribution.

When your supplement packaging complies with international requirements, you're not just legally secure — you're signaling maturity to potential partners and buyers. In high-barrier regions like the EU, EU supplement label requirements focus on shelf stability, additive limits, and approved claims.

Startups and exporters who get the labelling right from day one avoid delays, rejections, and reputational damage.

Prevents Misleading or Illegal Health Claims

Many businesses unintentionally overstep, promising results they can’t legally claim. For example, “Treats arthritis” or “Cures diabetes” are not allowed without clinical substantiation.

Different countries impose strict guidelines on labeling claims on supplements. In the USA, unauthorized claims require an FDA disclaimer. In Europe, only pre-approved nutrition and health claims are permitted. India and UAE have similar controls, prohibiting exaggerated or unsubstantiated marketing.

Violating these rules invites legal scrutiny, brand damage, and regulatory shutdowns.

Global Supplement Labelling Requirements

If you're scaling your supplement brand globally, know this, labelling is your passport. Compliant packaging is what gets your product through customs, onto shelves, and into the hands of paying customers.

What’s Common Across Markets?

Despite regional quirks, there are foundational rules nearly every country agrees on:

• Allergen Information – From peanuts to shellfish, common allergens must be clearly disclosed.
• Recommended Dosage – Daily intake, serving size, and usage instructions are mandatory.
• Ingredient Transparency – Active ingredients, excipients, and additives must be listed in descending order by weight or volume.
• Warning Statements – Includes disclaimers for pregnant women, children, and individuals on medication.

This baseline is your starting point. Miss any of these, and you’re asking for a regulatory takedown.

The Differences That Matter

Understanding labeling differences across countries is what separates compliant exporters from blocked shipments.

Region	Label Language	Claim Regulations	Required Authority
USA	English	Claims must include FDA disclaimer if not evaluated	FDA
India	English + Hindi	Health claims must be FSSAI-approved	FSSAI
Europe	Local language(s)	Only EFSA-approved claims allowed	EFSA
UAE	English + Arabic	No disease-curing claims permitted	ESMA

 

• In the UAE, bilingual labels (English + Arabic) are legally required.
• European supplement labelling mandates multilingual packaging in applicable member states.
• India’s FSSAI labeling guidelines specify font sizes, logo placement, and specific positioning of health warnings.
• In the US, including a Supplement Facts panel (not Nutrition Facts) is a legal must.

Understanding these variations is key to staying ahead of international supplement labeling trends. What works in California could be illegal in Dubai. One missed translation or unverified health claim could delay your entire shipment.

What are the labeling requirements for supplements in the USA?

Here's what you need to know if you're selling or exporting to the American market.

The United States regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA), with enforcement by the Food and Drug Administration (FDA). Under DSHEA compliance, your supplement label isn’t just packaging — it’s a legal document.

Mandatory Label Elements

Every dietary supplement sold in the U.S. must include:

• The term “Dietary Supplement” clearly on the front panel
• A full list of ingredients per serving in the Supplement Facts box
• Warning statements, allergen disclosures, and usage instructions
• The name and place of business of the manufacturer, packer, or distributor
• Batch number, expiry date, and net quantity of contents
• All information must be presented in English

If it’s missing any of these, the product risks being pulled from shelves, or worse, banned from entering the U.S. altogether.

Claims: Tread Carefully

Any health or nutritional claim must be backed by science and pre-approved by the FDA. Even structure-function claims (e.g., “supports immunity”) require a specific disclaimer:

“This statement has not been evaluated by the FDA…”

FDA supplement labelling is strict, but predictable. Fulfilling US dietary supplement label requirements gives you a competitive edge. Fail to comply, and you're not in the game.

Indian Supplement Labelling Laws

What is mandatory on nutraceutical labels in India? It’s a question every brand entering the Indian supplement market must answer, accurately. For those planning to start a health supplement brand in India, it is very important to know the supplement labelling laws in India.

In India, supplement labelling falls under the purview of the Food Safety and Standards Authority of India (FSSAI) and, in some cases, the Ministry of AYUSH (for Ayurveda-based formulations). FSSAI supplement labelling guidelines aren’t just policy, they’re mandatory checkpoints for market entry.

Key Labeling Requirements

To meet India nutraceutical labeling rules, your product must display:

• The word “Nutraceutical” prominently on the front label
• Ingredient percentages in accordance with ICMR (Indian Council of Medical Research) limits
• Mandatory advisories:
  • “Not for Medicinal Use”
  • Recommended daily dosage
  • Warning against excess consumption
• The FSSAI license number
• Clear disclosure of allergens, storage conditions, and net content

Labels must also comply with the Legal Metrology Act, which imposes penalties for incorrect quantity declarations or deceptive branding.

Special Case: Ayurvedic Supplements

If your product contains Ayurveda-based ingredients, it must satisfy AYUSH labelling compliance in addition to FSSAI standards — a dual requirement many exporters overlook.

Bottom line? Non-compliance can cost you shelf space, credibility, and market access. Get your FSSAI supplement labelling right, and you’ve already cleared one of the biggest hurdles in the Indian nutraceutical space.

What are Supplement Labelling Laws in UAE?

If you're exporting to the Gulf, this is a question you can’t afford to overlook. The UAE supplement label regulations are enforced by a trio of authorities:

• The Emirates Authority for Standardization and Metrology (ESMA)
• Dubai Municipality
• MOHAP (Ministry of Health and Prevention).

These bodies ensure that health supplements sold in the UAE meet strict criteria for clarity, compliance, and consumer safety.

Mandatory Labelling Requirements

To comply with Dubai health supplement compliance norms, your product must include:

• Arabic and English are both mandatory — no exceptions
• A clear designation as a “health supplement”
• Batch number, manufacturing date, and expiry date
• Accurate dosage instructions, usage guidelines, and storage conditions
• No curative or disease-treatment claims are allowed under any circumstances

The Arabic label requirements also extend to ingredient lists, warnings, and claims. Any oversight in translation or formatting can delay customs clearance — or worse, result in product rejection.

In the UAE, packaging isn’t just presentation. It’s a passport to market access. Get the label wrong, and your product doesn’t enter the country.

EU Supplement Labelling Laws + Country Comparison

What are the EU laws for dietary supplement labeling? Short answer: complex but standardized, if you know where to look.

The European Union enforces a unified framework to govern supplement labelling. But here’s the twist, while the base rules are harmonized, each member state adds its own flavor. And if you’re exporting to Europe, you need to understand both the baseline and the nuances.

Core Regulatory Framework

Three key regulations shape the EU supplement labelling rules:

• Directive 2002/46/EC: Defines what qualifies as a food supplement
• Regulation (EU) 1169/2011: Covers nutrition, ingredient listing, allergens, and legibility
• Regulation (EC) 1924/2006: Regulates health and nutrition claims, strictly vetted by EFSA

All products must be clearly labelled as “Food Supplement” include a nutrition table, storage conditions, allergen info, and comply with EFSA label compliance rules if making any claims.

Labels must also be in the local language of the target market and adhere to Regulation 1169/2011 supplements for visibility, size, and clarity.

Country-Specific Labelling Additions (At a Glance)

• Italy: Requires compliance with its national list of allowed botanical ingredients
• Spain: Uses the term "Complemento Alimenticio" instead of "food supplement"
• France: Mandates a list of pre-approved botanical species
• Poland: Enforces labelling through its Chief Sanitary Inspectorate

Bottom line: even within the EU, labelling differences across countries matter. A one-size-fits-all approach won’t cut it.

Want your supplement line to reach Germany, Spain, or Italy without regulatory delays? Nail the international supplement labeling trends, and localize with precision.

Global Labelling Compliance at a Glance

Region	Regulatory Body	Language Required	Health Claims	Special Requirements
USA	FDA + DSHEA	English	Only FDA-approved	Allergen, dosage, warnings
India	FSSAI + AYUSH	English	No curative claims	“Not for Medicinal Use” label
UAE	ESMA + MOHAP	Arabic+ English	Prohibited	No cure/treatment claims
Europe	EFSA + local bodies	Local Language	EFSA-approved	Country-specific warnings

 

Conclusion

Supplement labeling laws across the USA, India, UAE, and Europe isn’t just regulatory housekeeping—it’s a strategic move. Clear, compliant labels open export doors, reduce legal risks, and build consumer trust.

From FSSAI and AYUSH labeling compliance in India to FDA supplement labeling in the US and EFSA rules in Europe, each region has its own playbook. Understanding these labeling differences across countries helps brands stay competitive and export-ready.

Need help aligning your labels with global regulations?

Abha Biotechnology offers regulatory-backed third party manufacturing that ensures your product labels meet FSSAI, FDA, and EFSA standards, right from the first batch.

Let’s simplify your compliance journey, together.