The FSSAI said in an advisory that it was aware of nutraceutical manufacturers and retailers that were not adhering to mandatory labeling requirements and warning statements concerning products containing certain plant or botanical ingredients.
Examples include the leaf and fruit of Azadirachta indica A. Juss., commonly known as the neem or Margosa-Leaf tree, as well as the root, leaf and whole plant of Coleus forskohlii, also known as Gandiva or parn-yavani, and coffee seed.
The regulator stressed that nutraceuticals containing these ingredients should specify the permitted dosage and warning statements on the product labeling.
For instance, nutraceuticals containing neem leaf and fruit should state that they are “not recommended for males and females planning to conceive.” Those containing neem fruit should also state that they are “not recommended for children below five years old.”
Neem leaf, when used as powder in nutraceuticals, should also be used only within the permitted dosage range of one to three grams, while neem fruit, when used as pulp, can only be used in the permitted range of one to two grams.
In total, the FSSAI and the Ministry of AYUSH have identified 16 plant and botanical ingredients that require mandatory caution statements and permitted ranges of use on product labeling.
The rule comes under Schedule IV of 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.
The FSSAI said in the advisory that warning statements are required for products containing these botanical ingredients because of their physiological effects.
Other than health supplements and nutraceuticals, the rules are also applicable to Foods for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP).
“Under these regulations, FSSAI mandates that warning statements must be prominent, legible and clear to prevent misuse, especially by vulnerable populations,” the FSSAI said in the advisory. “The regulations specify certain warnings for individual plants or extracts based on their known side effects or contraindications.”
The regulator added that failure to comply with labeling rules could result in suspension or cancellation of licenses and imposition of penalties under the provisions of the Food Safety and Standards Act, 2006.
