FSSAI vs AYUSH Registration — Which Licence Does Your Food or Health Product Need?

Businesses dealing in health foods, nutritional supplements, herbal products and wellness items often face a critical question: Does my product need FSSAI (Food Safety and Standards Authority of India) registration, or AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy) licensing — or both? The answer determines your regulatory path, labelling requirements and compliance obligations. Here is the complete guide.

FSSAI Registration — Food Products

FSSAI governs all food products under the Food Safety and Standards Act 2006. FSSAI registration/licence is required for:

• All food and beverages — packaged, processed, or raw
• Dietary supplements (not Ayurvedic — e.g., protein powders, sports nutrition)
• Fortified foods (fortified rice, flour, oil)
• Health foods claiming nutritional benefits (not medical claims)
• Nutraceuticals — vitamins, minerals, amino acids sold as food
• Cafes, restaurants, bakeries, food manufacturers

FSSAI licences are classified as: Registration (turnover under ₹12 lakh), State Licence (₹12 lakh to ₹20 crore), Central Licence (above ₹20 crore or for importers/exporters, large manufacturers).

AYUSH Licensing — Ayurvedic/Herbal/Siddha/Unani Products

AYUSH licensing under the Drugs and Cosmetics Act 1940 is required for:

• Products making therapeutic, disease-treatment or medicinal claims ("cures diabetes," "treats arthritis")
• Ayurvedic proprietary medicines — herbal formulations, churna, asava, kashaya
• Homeopathic medicines
• Unani, Siddha formulations
• Classical Ayurvedic preparations listed in Ayurvedic pharmacopoeias

AYUSH Licence is issued by the State Licensing Authority (Drug Inspectors under State Drug Control departments). In Kerala, the Kerala Drugs Control Department issues AYUSH licences.

When Both Licences Are Required

• Products that are sold as both food and medicine (e.g., herbal teas that make health claims)
• Companies manufacturing Ayurvedic products AND distributing them through food/pharmacy channels
• Importers of health products that include both food and AYUSH-classified items

Labelling — The Critical Distinction

• FSSAI product: Cannot make therapeutic claims ("not intended to diagnose, treat, cure or prevent any disease")
• AYUSH product: Can make disease-specific claims — but only claims supported by the AYUSH pharmacopoeia or approved by the licensing authority
• Making therapeutic claims on a FSSAI-labelled product is a violation of both FSSAI and AYUSH regulations

Conclusion

The FSSAI vs AYUSH determination depends on the product formulation, health claims made, and the regulatory pathway chosen — and getting it wrong can lead to product seizure and licence cancellation. SPOTON provides regulatory pathway advisory for health product companies and assists with FSSAI and AYUSH licence applications. Contact us for expert food and health product compliance services.