The Food Safety and Standards Authority of India (FSSAI) has directed nutraceutical and health supplement makers to ensure that they adhere to the mandatory labelling and warning statement requirements for products containing plant and botanical extracts in accordance with the regulations. The regulator has asked them to review their product labels to ensure compliance as violations will attract stringent action, including suspension of licences and imposition of penalties.
For instance, when neem fruit extracts or Gandiva extracts are used in a product, the regulations prescribe warning statements such as “Not recommended for children below 5 years” on labels. Similarly when Papita leaf or juice is used in a product, it is required to carry a warning statement: “Not recommended during pregnancy.”
In a recent advisory, FSSAI said, “It has been observed that several food business operators engaged in the manufacturing and sale of nutraceuticals, health supplements or foods for special dietary use are not adhering to mandatory labelling requirements and warning statements as prescribed in,” regulations for products using plant or botanical ingredients.
The regulator said that the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, stipulate compliance standards concerning the permissible limit of plant and botanical ingredients and their extracts either alone or in combination of ingredients. The regulations also imposes rigorous labelling requirements, prohibiting any medicinal claims or suggestions of disease cure.
“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,” it added in its advisory.
“Considering consumer safety and the prevention of misleading claims, manufacturers of health supplements, nutraceuticals, are hereby directed to ensure mandatory labelling indicating plant part used and immediate compliance with the specific disclaimer or cautionary statement or warnings based on the nature of the ingredient,” the advisory said. It has asked health supplements and nutraceutical manufacturers to review their labels and formulations to ensure that their products are in compliance with the regulations.
“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 added.