Launching A New Nutritional Product In India: A Legal And Regulatory Perspective Under FSSAI

Introduction

The Indian food and nutrition industry is undergoing an unprecedented transformation. From functional beverages and protein bars to herbal nutraceuticals and fortified foods, the market has seen a surge in innovation. However, with innovation comes the challenge of regulatory compliance.

Every new food product whether manufactured domestically or imported must comply with the legal framework established under the Food Safety and Standards Act, 2006 ("FSS Act") and the regulations framed thereunder by the Food Safety and Standards Authority of India (FSSAI).

The FSSAI serves as India's apex regulatory body ensuring that food products are safe, accurately represented, and traceable. A misstep in compliance can result in product recalls, license suspension, monetary penalties, and even criminal prosecution.

The Statutory Framework

The cornerstone of India's food law is the Food Safety and Standards Act, 2006, which consolidates various earlier food laws such as the Prevention of Food Adulteration Act, 1954 and the Fruit Products Order, 1955.

Under Section 16(1) of the FSS Act, the FSSAI is empowered to specify standards and guidelines to ensure that food is safe for human consumption. Section 22 of the Act specifically governs functional foods, nutraceuticals, and novel foods, laying down restrictions on their manufacture and sale unless specifically permitted by regulations.

The relevant subordinate legislations include:

• Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011
• Food Safety and Standards (Packaging and Labelling) Regulations, 2011
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022 ("Nutraceutical Regulations")
• Food Safety and Standards (Import) Regulations, 2017
• Food Safety and Standards (Advertising and Claims) Regulations, 2018

Together, these constitute the regulatory ecosystem governing every aspect of product formulation, licensing, packaging, labelling, and marketing.

Understanding Product Categorisation

A foundational step before product development is determining under which category the product will be regulated. The FSSAI differentiates food products as follows:

1. Standardised Foods

• Products for which standards already exist under the FSSAI regulations (e.g., milk, juices, biscuits, tea, oils).
• Legal implication: No separate product approval is required; compliance with the prescribed standard and licensing is sufficient.

2. Proprietary Foods

• Defined under Regulation 2.12 of the Food Product Standards and Food Additives Regulations, 2011, these are foods not standardised but composed of approved ingredients.
• Legal implication: The manufacturer must ensure that all ingredients are permitted, no novel ingredients are used, and the label does not make therapeutic claims.

3. Novel Foods

• As per Section 22 of the FSS Act and Regulation 3(1)(b) of the Nutraceutical Regulations, a "novel food" refers to food with no history of human consumption in India or food derived through new technologies or processes.
• Legal implication: Such products require pre-market approval based on safety, toxicological, and clinical data.

4. Nutraceuticals and Health Supplements

• These include food products intended to supplement the diet with vitamins, minerals, botanicals, probiotics, or bioactive substances.
• Legal implication: Governed by the 2022 Nutraceutical Regulations, these products must not claim to treat or cure diseases (which would make them "drugs" under the Drugs and Cosmetics Act, 1940).

Licensing and Product Approval Procedures

1. FSSAI Licensing

All Food Business Operators (FBOs) are required to obtain a license or registration under Section 31 of the FSS Act. Licenses are issued through the Food Safety Compliance System (FoSCoS) portal and divided as follows:

Practical Insight: In practice, even medium-sized businesses often apply directly for a Central License to ensure operational flexibility for future expansion or inter-state distribution.

2. Product Approval (Non-standardised / Novel Foods)

If the product falls outside the scope of standardised foods, the company must apply for product approval under Section 22 read with Section 16(5) of the FSS Act. The Product Approval Process involves submission of:

• Ingredient list with CAS/INS numbers
• Manufacturing process and flowchart
• Certificate of analysis for each ingredient
• Nutritional composition and shelf-life study
• Safety or toxicological data for new ingredients
• Label drafts and intended claims
• Certificates from NABL-accredited or FSSAI-recognised labs

The application is filed online through the FoSCoS Product Approval module, and evaluated by the Product Approval and Review Committee (PARC).

Timelines: In theory, approvals may take 60–120 days, but practically, delays of 6–9 months are common due to data clarifications or ingredient safety queries.

Practical Insight: Many start-ups underestimate the level of scientific substantiation FSSAI demands. Engaging a food technologist and regulatory consultant at the formulation stage can drastically reduce delays.

Ingredient and Additive Regulations

FSSAI maintains positive lists of permissible ingredients and additives. Any ingredient not present in these lists is considered "non-compliant" unless supported by safety data. Regulation 16 of the Nutraceutical Regulations, 2022 requires that all botanical ingredients be sourced from the Indian Pharmacopoeia, Ayurvedic Pharmacopoeia, or other recognised compendia.

Schedule IV prescribes limits for vitamins and minerals, usually capped at RDA (Recommended Dietary Allowance) unless justified otherwise.

Practical Insight: Companies often attempt to include foreign nutraceutical ingredients commonly used in EU or US products. However, FSSAI does not automatically recognise foreign approvals (such as EFSA or FDA clearances). A detailed safety dossier including toxicology, clinical, and historical usage data must accompany the application.

Packaging and Labelling Compliance

Under the Packaging and Labelling Regulations, 2011 (as amended in 2020), every food product must display:

• Name of the food and brand
• Ingredient list in descending order
• Nutritional information (energy, protein, fat, carbohydrates, sugars, etc.)
• Veg/Non-veg logo
• FSSAI License number and logo
• Net quantity, manufacturer address, batch/lot number
• Shelf-life and storage instructions
• Country of origin (for imports)
• Allergen declaration

For nutraceuticals, additional details such as the daily usage quantity, contraindications, and warnings are mandatory under Regulation 8 of the Nutraceutical Regulations, 2022.

Practical Insight: Even minor discrepancies (like incorrect font size, missing license number, or improper allergen symbol) have led to show-cause notices and product seizures. Companies should conduct a pre-print legal and regulatory label audit before packaging.

Claims, Advertising, and Consumer Protection

The Food Safety and Standards (Advertising and Claims) Regulations, 2018 and Consumer Protection Act, 2019 regulate product advertising and marketing.

• Health Claims: Must be supported by adequate scientific evidence.
• Nutrient Function Claims: Allowed only if the nutrient has a recognised physiological role.
• Prohibited Claims: Any claim suggesting prevention, cure, or treatment of diseases (e.g., "treats diabetes", "reduces cholesterol") is strictly prohibited.
• Section 53 of the FSS Act empowers FSSAI to impose a penalty of up to ₹10 lakhs for misleading advertisements. Additionally, the Central Consumer Protection Authority (CCPA) under the Consumer Protection Act may impose separate penalties or order withdrawal of advertisements.

Practical Insight: From a risk management perspective, companies should maintain a "claims substantiation file" a repository of published studies, clinical trials, or expert opinions supporting every claim made in advertisements or on labels.

Imports and International Launches

For imported nutritional or health products, the Food Safety and Standards (Import) Regulations, 2017 apply. Key steps include:

• Importer license under FoSCoS
• Pre-clearance from FSSAI Designated Officer at the port of entry
• Submission of documents such as: Bill of entry and product approval, country of origin certificate, ingredient safety data, label in English and certificate of Analysis from accredited lab

FSSAI conducts sampling and laboratory analysis at port. Products failing standards are subject to destruction or re-export orders.

Practical Insight: Importers must ensure ingredient compliance before shipment. Once a consignment reaches port, any non-conformity can lead to demurrage charges and significant commercial losses.

Enforcement, Penalties, and Risk Mitigation

FSSAI has broad enforcement powers under Chapter X of the FSS Act:

Practical Insight: FSSAI enforcement is increasingly data-driven, with AI-based monitoring of e-commerce and advertising. Proactive compliance, internal audits, and maintaining documentary evidence of approvals are now essential for brand protection.

Common Challenges in Practice

Despite the structured framework, several practical bottlenecks remain:

• Ambiguity in classification: Products often straddle the line between "nutraceutical" and "drug."
• Approval delays: The scientific panel's queries and safety clarifications prolong the process.
• Lack of guidance on foreign ingredients: FSSAI's non-recognition of foreign dossiers complicates innovation.
• Regulatory inconsistency across states: Different interpretation by local Designated Officers creates uncertainty.
• Limited testing capacity: Delays in lab testing at ports or NABL facilities cause commercial disruptions.

Strategic and Practical Recommendations

1. Regulatory Planning at R&D Stage: Before formulation, map each ingredient against FSSAI-approved lists to avoid reclassification later.
2. Label and Claims Legal Vetting: Have every claim reviewed by both legal and nutrition science experts.
3. Maintain Robust Documentation: Keep all approval letters, test reports, and declarations ready for inspection.
4. Periodic Compliance Audit: Conduct internal audits every six months to identify deviations.
5. Collaborate with Regulators: Engage with FSSAI through pre-submission meetings or clarifications; this builds credibility and avoids rejection.
6. Cross-functional Compliance Teams: Combine marketing, R&D, and legal teams to ensure coordinated compliance across departments.

Conclusion

Launching a new nutritional or health product in India is both an opportunity and a regulatory challenge. The FSSAI regime, while stringent, aims to protect consumer safety and maintain product integrity.

For companies, early-stage compliance is not merely a legal necessity but a strategic advantage. A product that is well-documented, lawfully approved, and transparently labelled inspires greater consumer trust and investor confidence.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.