NEW DELHI: The Food Safety and Standards Authority of India (FSSAI) has issued an advisory reinforcing mandatory compliance with labelling standards and warning statements for products containing plant and botanical ingredients or their extracts.
The regulator also warned that actions such as cancellation of licences or imposition of penalties will be taken if violations are found.
The detailed advisory was issued as it was observed that several Food Business Operators (FBOs) engaged in the manufacture and sale of Nutraceuticals, Health Supplements, or food for special dietary use or food for special medical purpose etc., are not adhering to the mandatory labelling requirements and warning statements as prescribed under Schedule IV (List of plant or botanical ingredients) of the aforesaid regulations.
The Schedule IV of the said Regulations covers a vast array of botanical ingredients, many of which require specific cautionary labelling due to their physiological effects.
Under these regulations, FSSAI mandates that warning statements must be prominent, legible, and clear to prevent misuse, especially by vulnerable populations.
The regulations specify certain warnings for individual plants or extracts based on their known side effects or contraindications.
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, constitute a comprehensive regulatory framework designed to regulate the manufacture, sale and distribution of non-conventional food categories viz., Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, food with added prebiotic and probiotic ingredients, Functional Food and Novel Food in India.
These regulations stipulate compliance standards concerning the permissible limit inter alia of plant and botanical ingredients and their extracts either alone or in combination of ingredients.
Furthermore, the regulation imposes rigorous labelling requirements, prohibiting any medicinal claims or suggestions of disease cure, and strictly limits the use of ingredients to those explicitly categorized under the designated schedules to ensure consumer safety and product efficacy within the ambit of the FSS Act, 2006.
The FSSAI released the consolidated list of all such plant and botanical ingredients/extracts where mandatory declaration/cautionary statements required to be displayed when such plant/botanical ingredients or extracts are used has been prepared in consultation with the Ministry of Ayush.
"In view of the above, considering consumer safety and the prevention of misleading claims, manufacturers of health supplements, nutraceuticals, FSDU, FSMP are hereby directed to ensure mandatory labelling indicating plant part used and immediate compliance with the specific disclaimer/cautionary statement or warnings based on the nature of the ingredient as provided in respect of several individual plant/botanical ingredients," the advisory said.
“Non-compliance to the statutory requirement as above constitutes violation of provision under section 23 of the FSS Act 2006 and shall attract stringent action under Section 52 of the FSS Act, 2006,” the advisory added.
The FBOs were also directed to review their labels and formulations to ensure that the products are in compliance with the provisions laid down under the FSS Act 2006 and the regulations as amended from time to time.
“Failure to comply with these labelling mandates shall render the FBO liable for regulatory action, including suspension or cancellation of licenses and imposition of penalties under the provisions of the Food Safety and Standards Act, 2006,” it said.
