Nutraceuticals in India are regulated by the Food Safety and Standards Authority of India (FSSAI) under the 2016 Health Supplements and Nutraceuticals Regulations. The framework covers ingredients, safety, manufacturing, and labelling requirements for eight categories, including nutraceuticals, health supplements, probiotics, prebiotics, and novel foods.
Manufacturers, importers, and sellers must obtain the appropriate FSSAI license and comply with applicable labelling, packaging, safety, and quality standards. FSSAI has also updated the framework through subsequent amendments and directions.
Key Takeaways
- FSSAI regulates nutraceuticals under the 2016 Health Supplements and Nutraceuticals Regulations.
- The framework covers eight categories, including health supplements, nutraceuticals, FSDU, FSMP, plant or botanical-based specialty foods, probiotics, prebiotics, and novel foods.
- Businesses manufacturing, importing, or selling nutraceutical products must obtain the appropriate FSSAI license based on their activity and eligibility.
- Nutraceutical labels must comply with the FSS (Labelling and Display) Regulations, 2020, while packaging must meet the applicable FSS (Packaging) Regulations, 2018.
- Businesses must support health and nutritional claims with appropriate scientific evidence and avoid misleading claims.
- Manufacturers must follow applicable GMP, microbiological, chemical, and food safety standards and maintain required testing and quality-control records.
- FSSAI has updated the nutraceutical framework through subsequent amendments and directions, including changes to permitted ingredients and additives.
What Are Nutraceuticals?
Nutraceuticals are food products that provide health or physiological benefits beyond basic nutrition. The term combines “nutrition” and “pharmaceutical.” These products support specific nutritional or health needs but remain regulated as food products in India.
They broadly include:
- Dietary supplements: Concentrated sources of nutrients such as vitamins, minerals, amino acids, and permitted botanical ingredients, usually consumed as tablets, capsules, powders, or liquids.
- Functional foods: Foods that provide additional health benefits, such as fortified foods, probiotic products, and omega-3-enriched foods.
Common examples include vitamin supplements, protein powders, probiotic drinks, omega-3 products, and permitted herbal supplements.
Who Regulates Nutraceuticals in India?
The Food Safety and Standards Authority of India (FSSAI) regulates nutraceuticals under the Food Safety and Standards Act, 2006. FSSAI classifies these products as food rather than drugs, so food safety regulations apply instead of pharmaceutical regulations.
The primary framework is the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016. FSSAI and the relevant State Food Safety Authorities oversee compliance.
It classifies products in 8 categories:
| Category | Description |
| Health Supplements | Concentrated sources of nutrients intended to supplement the normal diet. |
| Nutraceuticals | Products containing nutrients or bioactive compounds that provide physiological or health benefits. |
| Foods for Special Dietary Use (FSDU) | Foods specially formulated to meet particular dietary requirements. |
| Foods for Special Medical Purpose (FSMP) | Foods formulated for the dietary management of specific medical conditions under appropriate supervision. |
| Specialty Foods Containing Plants or Botanicals | Products containing permitted plant or botanical ingredients. |
| Foods Containing Probiotics | Foods containing beneficial live microorganisms in permitted amounts. |
| Foods Containing Prebiotics | Foods containing ingredients that support beneficial gut microorganisms. |
| Novel Foods | Foods or ingredients without a history of safe human consumption in India that must meet applicable approval requirements. |
Licensing Requirements Under FSSAI Nutraceutical Regulations
Businesses that manufacture, import, distribute, or sell nutraceuticals must obtain the appropriate FSSAI registration before starting operations. The applicable category depends on the business activity, turnover, and other licensing criteria:
- Basic Registration: Generally applies to petty food businesses with annual turnover up to ₹12 lakh.
- State License: Generally applies to eligible businesses with turnover above ₹12 lakh and up to ₹20 crore.
- Central License: Applies to businesses exceeding the prescribed turnover threshold and to activities that require central licensing, including food imports.
Labelling and Packaging Requirements Under FSSAI Nutraceutical Regulations
Nutraceutical products must comply with the FSS (Labelling and Display) Regulations, 2020 and applicable requirements under the FSS (Packaging) Regulations, 2018. Key labelling requirements include:
- Ingredients and nutrition: Declare the ingredients, quantities, nutritional information, and other mandatory particulars.
- Serving information: State the recommended serving size, dosage where applicable, and directions for use.
- Health claims: Ensure health and nutrition claims have scientific support and comply with FSSAI requirements. Avoid misleading claims or claims that the product can prevent, treat, or cure a disease.
- Warnings: Display applicable cautionary statements and restrictions, including statements relating to children, pregnant women, or lactating mothers where required.
- Product details: Display the FSSAI license number and logo, manufacturer’s or importer’s details, batch number, and applicable date markings.
Ingredient and Safety Standards Under FSSAI Nutraceutical Regulations
Nutraceutical formulations must use permitted ingredients and additives within the limits prescribed by FSSAI. Businesses should verify the applicable schedules before developing or modifying a product.
- Permitted ingredients: Use only ingredients permitted for the relevant product category and within prescribed limits.
- Permitted additives: Use only approved food additives and comply with their specified conditions and limits.
- Good Manufacturing Practices: Follow GMP and food-safety management practices covering hygiene, sanitation, production, and process controls.
- Safety standards: Ensure compliance with prescribed limits for microorganisms, heavy metals, pesticide residues, and other contaminants through appropriate testing.
Recent Regulatory Updates
FSSAI periodically updates the nutraceutical framework to reflect new scientific evidence, permitted ingredients, and industry developments. These include:
- 30 March 2022 directive: FSSAI updated requirements for permitted ingredients, additives, and standards applicable to nutraceutical and health-supplement products.
- Ongoing schedule updates: FSSAI continues to add, modify, or clarify permitted ingredients and additives under the 2016 regulations.
- Formulation changes: A product that met the requirements earlier may require review if FSSAI later changes the applicable ingredient or additive requirements.
Note: Businesses should therefore check the latest FSSAI notifications and applicable schedules before formulating, manufacturing, importing, or relabelling a nutraceutical product.
Consequences of Non-Compliance Under the FSS Act
Failure to meet nutraceutical requirements can result in regulatory and financial consequences under the Food Safety and Standards Act, 2006, including:
- Monetary penalties for violations such as substandard products, misbranding, or misleading claims.
- Product recall or seizure of non-compliant or unsafe products.
- Suspension or cancellation of the FSSAI registration or license.
- Prosecution for serious violations involving unsafe food or other offences under the Act.
