Applicable Act/Rule: Food Safety and Standards Act, 2006; Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
Applicable Section/Rule: Section 23 and Section 52 of the Food Safety and Standards Act, 2006; Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 7(3)(v), 8(2)(i), 9(2)(i), 12(1)(i), 12(2), 12(3)(i), 12(3)(ii) and 12(3)(iii) of the Food Safety and Standards Regulations, 2016.
The Food Safety and Standards Authority of India (FSSAI) has issued directions concerning compliance with labelling requirements and cautionary statements for plant and botanical ingredients and their extracts used in health supplements, nutraceuticals, food for special dietary use, food for special medical purposes and other categories covered under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
Food Business Operators (FBOs) engaged in the manufacture and sale of the specified food categories are required to comply with the labelling requirements and warning statements prescribed under Schedule IV of the regulations for plant and botanical ingredients and their extracts. The cautionary statements must correspond to the ingredients concerned and include the prescribed warnings relating to permitted daily usage, contraindications and restrictions for specific groups.
The document specifies that non-compliance with these statutory requirements constitutes a violation of Section 23 of the Food Safety and Standards Act, 2006, and attracts action under Section 52 of the Act.
Food Business Operators are directed to review their product labels and formulations for compliance with the Act and the applicable regulations. Failure to comply with the labelling requirements may result in regulatory action, including suspension or cancellation of licences and imposition of penalties under the Food Safety and Standards Act, 2006.
The attached document also contains an annexure listing botanical ingredients, plant parts, permitted daily usage ranges and associated cautionary statements. Examples include Azadirachta indica (Neem), Coleus forskohlii, Carica papaya and Coffea arabica, with specified usage limits and warnings for certain groups.
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