February 13, 2025

Nutraceuticals, bridging "nutrition" and "pharmaceuticals," are food-based products delivering physiological benefits and promoting health when consumed appropriately. In India, the Food Safety and Standards Authority of India (FSSAI) oversees nutraceuticals under the Food Safety and Standards Act, 2006.

Understanding the Regulatory Framework

Several regulations govern nutraceuticals in India:

  • FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (as amended) 

These regulations apply to food items and formulations for humans above 2 years, aiming to promote health maintenance.

  • Other important regulations: 

FSS (Organic Foods) Regulations, 2017, FSS (Food Product Standards and Food Additive) Regulations, 2011, FSS (Packaging and Labelling) Regulations, 2011, FSS (Advertising and Claims) Regulations, 2018, FSS (Licensing and Registration of Food Businesses) Regulation, 2011, FSS (Contaminants, Toxins and Residues) Regulations, 2011, and FSS (Import) Regulations, 2017 (for imported nutraceuticals).

Key Points for Over the Counter (OTC) Nutraceuticals

  • Definition: The Nutraceutical Regulations apply to food items prepared for humans above the age of 2 years, with the aim to promote maintenance of health.
  • Permitted Formats: Nutraceuticals can be formulated as single or combined ingredients, or their extracts (processed or unprocessed), in conventional food formats like liquid, powder, tablets, capsules, and sprays.
  • Exclusions: Naturally occurring foods are excluded, meaning minimally processed items like fruits and vegetables can't be marketed as nutraceuticals.
  • Health Claims: Claims about health benefits, such as enhanced function, health maintenance, or immunity are allowed. Drug-like claims suggesting disease prevention or cure are prohibited. Claims lacking scientific basis or involving novel ingredients need FSSAI approval.
  • Licensing and Registration: Licensing is covered under the FSS (Licensing and Registration of Food Businesses) Regulations, 2011. Product registration may require import, manufacturing, and marketing licenses, along with other clearances.
  • Scientific Rationale: A scientific rationale is needed for the combination of ingredients, potentially based on peer-reviewed literature.

Navigating the Regulatory Pathway with Maven

Maven offers comprehensive support to navigate the complexities of the Indian nutraceutical market. Their services include:

  • Regulatory Overview and Product Classification: Determining the correct regulatory pathway for your specific product.
  • Compliance for Food Ingredients and Additives: Ensuring all ingredients and additives meet regulatory standards.
  • Claims Review: Reviewing and substantiating health claims based on scientific literature.
  • Labeling Review: Ensuring that your product labels comply with all regulations.
  • Product Registration/Notification: Managing the registration and notification process.
  • Go-to-Market Services: Providing comprehensive support for launching your product in the Indian market.

Maven's team possesses expertise in global health authority regulations and specializes in registration procedures for various food supplement and nutraceutical categories. They can assist with:

  • Product compliance.
  • Label assessment.
  • Claims review.
  • Product classification.
  • Registration.
  • Ensuring market continuity.

Challenges and Considerations

  • Implementation: Effective implementation and coordinated actions are crucial for ensuring food safety and nutrition.
  • Consumer Awareness: Consumer understanding of the link between diet and health influences demand.
  • Need for Amendments: Continuous updates to the regulatory framework are needed to protect consumers and accommodate changes in the industry.

Conclusion

Entering the Indian nutraceutical market requires a strong understanding of the regulatory landscape. Maven offers the expertise to ensure compliance and successful market entry. With Maven's support, you can confidently navigate the regulatory pathway and bring safe, effective nutraceutical products to Indian consumers