Nutraceutical Fssai Regulation
Regulations
Nutraceuticals Regulations FSSAI
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- Regulations
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Interesting Topics
Nutraceuticals Regulations FSSAI
Table of Content
- 1. Outlined in FSSAI Nutraceutical Regulations 2022
- 2. FSDU and FSMP Category of foods Mentioned in the FSSAI Nutraceutical
- 3. Schedule of Ingredients mentioned in the Nutraceutical Regulation
- 4. Standards/ Criteria for the Purity of the ingredient
- 5. Scopre and Labelling requirements for Food for Sports person
1. What are the key categories outlined in the FSSAI Nutraceutical Regulations, 2022?
The FSSAI regulations define categories including
- Health Supplements,
- Nutraceuticals,
- Food for Special Dietary Use,
- Food for Special Medical Purposes, and
- Prebiotic/Probiotic Foods.
These categories aim to classify food products based on their specific health benefits and intended purposes, offering clearer guidelines for manufacturers and consumers.
[Refer Page 2 of 76, Annexure 1, Section 2, Category 2 – under Scope and categories covered, Sub-section (2): Categories covered– FSSAI Direction dated 30 March 2022 (PDF)]
2. Explain about the FSDU and FSMP category of foods mentioned in the FSSAI Nutraceutical Regulations, 2022?
Food for special dietary use (FSDUs) are designed for individuals with dietary restrictions, like gluten-free or diabetic foods, ensuring proper nutrition while excluding certain ingredients. The composition of FSDUs can vary significantly from the composition of comparable ordinary foods. Food for Special Medical Purposes (FSMPs) are specially formulated to manage medical conditions, such as enteral feeding formulas or products for malnutrition. Both categories require compliance with stringent labelling, ingredient safety, and health claims to ensure consumer safety.
[Refer Page 3 of 76, Annexure 1, Section 2, Category 3 – under Definitions, Sub-section (c): Food for special dietary use – FSSAI Direction dated 30 March 2022 (PDF)]
3. Explain about the four schedules of ingredients mentioned in the nutraceutical regulations, 2022?
The FSSAI directive outlines four schedules of ingredients:
Schedule I: Approved ingredients for nutraceuticals (e.g., vitamins, minerals, herbal extracts).
Schedule II: Approved ingredients for health supplements (e.g., probiotics, botanicals).
Schedule III: Ingredients for Food for Special Dietary Use (e.g., gluten-free, low-sodium).
Schedule IV: Ingredients for Food for Special Medical Purposes (e.g., enteral feeding formulas, medical nutritional products).
[Refer Page 4 of 76, Annexure 1, Section 2, Category 5 – under General requirements for all categories, Sub-section (2): (a) Ingredients – FSSAI Direction dated 30 March 2022 (PDF)]
4. Explain about the standards/criteria for the purity of the ingredients as well as the additives, processing aids and flavours used in the food products?
According to the nutraceutical standards, the purity criteria of ingredients used in the category of the foods will be specified by FSSAI. In case of the unspecified criteria, the purity criteria are generally based on the pharmacopeia standards. The list of additives, excipients, processing aids and flavours are mentioned in the regulations. Prior approval of FSSAI is required for using any additives which are not specified under the regulations.
[Refer Page 5 of 76, Annexure 1, Section 2, Category 5 – under General requirements for all categories., Sub-section (4): Additives, processing aids and flavours – FSSAI Direction dated 30 March 2022 (PDF)]
5. Explain about the scope and labelling requirements for 'Food for Sportsperson' mentioned in the FSSAI Nutraceutical Regulations, 2022?
The FSSAI guidelines for ‘Food for Sportsperson’, designed to meet the nutritional needs of athletes and active individuals. These foods must support physical performance, recovery, and overall well-being. Labelling requirements include clear details about the product’s intended use, nutritional content, and any specific health claims. The front of pack label should include the following statement – ‘FOR SPORTSPERSON ONLY’. The packaging must also include warnings for proper usage, especially regarding dosage, to ensure safety and effectiveness for sportspersons.
[Refer Page 13 of 76, Annexure 1, Section 2, Category 3.1.2 – under Food for Sportsperson, Sub-section (b): Labelling requirement(s) – FSSAI Direction dated 30 March 2022 (PDF)]
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