Food Supplements Vs Nutraceuticals Under FSSAI: Key Regulatory Differences Brands Must Know In 2025

Your turmeric capsule is not just “natural,” and your vitamin drink is not merely “fortified.” Under Indian food law, these products fall into clearly defined regulatory categories either as food supplements (health supplements) or nutraceuticals. Choosing the wrong classification can result in licensing delays, label non-compliance, rejected claims, or outright product bans. 

As India’s health and wellness market continues to grow rapidly, FSSAI compliance has become a strategic business priority. The distinction between food supplements and nutraceuticals under the Food Safety and Standards Authority of India (FSSAI) directly affects formulation limits, ingredient approvals, dosage justification, labelling, advertising claims, and market authorization. 

In this detailed guide, Maven Regulatory Solutions breaks down the difference between food supplements and nutraceuticals under FSSAI law, explains recent regulatory updates in 2025, and highlights how one classification decision can shape your product’s regulatory success. 

FSSAI Regulatory Framework for Food Supplements and Nutraceuticals 

Both food supplements and nutraceuticals are regulated under: 

Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016, along with amendments and guidance updates issued through 2025. 

FSSAI Product Categories Include: 

• Health Supplements (Food Supplements) 
• Nutraceuticals 
• Foods for Special Dietary Use (FSDU) 
• Foods for Special Medical Purpose (FSMP) 
• Novel Foods 

Understanding the correct category is critical, as FSSAI applies distinct compliance requirements to each. 

What Are Food Supplements Under FSSAI? 

Under FSSAI regulations, food supplements are classified as Health Supplements. 

Definition 

Food supplements are products intended to supplement the normal diet by providing concentrated sources of nutrients or other substances with a nutritional role, but without pharmacological or therapeutic action. 

Common Ingredients in Food Supplements 

• Vitamins (A, B-complex, C, D, E) 
• Minerals (Calcium, Iron, Zinc, Magnesium) 
• Amino acids 
• Proteins 
• Essential fatty acids 
• Approved plant-based extracts 

Key Regulatory Conditions 

• Ingredients must be listed in FSSAI Schedules I–VI 
• Dosages must not exceed ICMR-prescribed RDA limits 
• Intended for general health maintenance, not functional outcomes 

Food supplements are considered low-risk products when formulated within approved limits. 

What Are Nutraceuticals Under FSSAI? 

Definition 

Nutraceuticals are products derived from food sources that provide physiological or functional benefits beyond basic nutrition. They contain bioactive compounds that act at a cellular or biochemical level. 

Common Nutraceutical Ingredients 

• Curcumin (from turmeric) 
• Polyphenols and flavonoids 
• Lycopene 
• Omega-3 concentrates 
• Probiotics and prebiotics 
• Plant sterols and antioxidants 

Key Regulatory Characteristics 

• Functional benefit must be scientifically substantiated 
• Ingredients may exceed RDA levels with FSSAI approval 
• Products cannot claim disease treatment or cure 

Nutraceuticals sit at the intersection of food and science, making regulatory scrutiny significantly higher. 

Scientific Difference: Food Supplements vs Nutraceuticals 

Food supplements prevent deficiencies, while nutraceuticals aim to optimize health and reduce disease risk—without crossing into medicinal claims. 

Regulatory Differences Under FSSAI Law 

1. Licensing & Product Classification 

• Food supplements fall under Health Supplement licensing 
• Nutraceuticals require separate category licensing 
• Novel ingredients or functional claims require additional safety dossiers 

2. Ingredient Approval & Dosage Limits 

3. Labelling Requirements 

Both categories must comply with FSSAI labelling regulations, including: 

• Product category declaration 
• Usage instructions 
• Dosage limits 
• Mandatory disclaimer: “NOT FOR MEDICINAL USE” 

Additional Nutraceutical Label Requirements 

• Source of bioactive ingredient (plant/animal) 
• Functional claim substantiation 
• Disease-related disclaimers 

 4. Health Claims & Advertising 

• Food Supplements: Only general claims (e.g., “supports immunity”) 
• Nutraceuticals: Specific functional claims allowed, if scientifically proven 

Misleading or pharma-like claims are strictly prohibited. 

Key FSSAI Updates in 2025 You Must Know 

Recent regulatory tightening includes: 

• Mandatory QR codes for traceability on nutraceuticals priced above ?1,000 
• Prohibition of pharma-like substances in food products 
• Clinical data requirement for high-dose botanicals 
• Enhanced scrutiny of novel food ingredients 
• Introduction of Front-of-Pack Nutrition Labelling (FOPNL) for supplements and functional beverages 

These updates significantly impact product development and reformulation strategies. 

Why Misclassification Can Derail Your Product Launch 

Incorrect classification can lead to: 

• FSSAI license rejection 
• Label non-compliance notices 
• Forced reformulation 
• Advertising restrictions 
• Market withdrawal 

Early regulatory assessment is critical to avoid costly delays and reputational risk. 

How Maven Regulatory Solutions Supports FSSAI Compliance 

Maven Regulatory Solutions provides end-to-end regulatory support for: 

• Food supplement vs nutraceutical classification 
• Ingredient & dosage assessment 
• Scientific claim substantiation 
• Label and formulation review 
• FSSAI license and approval strategy 

Our experts help brands align science, formulation, and regulation right from concept to market. 

Frequently Asked Questions (FAQs) 

1.Can nutraceuticals exceed RDA limits under FSSAI? 

Yes, provided scientific justification and FSSAI approval are obtained. 

2.Are herbal products automatically nutraceuticals? 

No. Herbal products may be food supplements or nutraceuticals depending on dosage and functional claims. 

3.Can nutraceuticals claim disease treatment? 

No. Any curative or therapeutic claim is prohibited under FSSAI law. 

4.Is QR code labelling mandatory for all supplements? 

Currently applicable to nutraceuticals priced above ?1,000, with phased implementation. 

Conclusion 

The difference between food supplements and nutraceuticals under FSSAI law is not semantic it is strategic. The correct classification determines your regulatory pathway, market approval timeline, claim flexibility, and compliance risk. 

As FSSAI regulations continue to evolve in 2025, proactive regulatory planning is the key to sustainable success. With expert guidance from Maven Regulatory Solutions, brands can confidently navigate classification decisions and bring compliant, market-ready products to Indian consumers.