Food regulator FSSAI on Monday warned manufacturers and sellers of nutraceuticals, health supplements and special dietary products of regulatory action for failing to comply with mandatory labelling requirements and warning statements.
The Food Safety and Standards Authority of India (FSSAI) expressed concern that several food business operators (FBOs) were not following prescribed norms, particularly those governing plant and botanical ingredients and their extracts.
In an advisory issued on Monday, the regulator directed businesses to ensure strict compliance with labelling requirements under the existing food safety regulations.
๐๐ฆ๐ฆ๐๐ ๐ณ๐น๐ฎ๐ด๐ ๐ป๐ผ๐ป-๐ฐ๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ
"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," FSSAI said.
The regulator said the advisory specifically addresses compliance with warning statements for products containing plant and botanical ingredients and their extracts.
Such ingredients may be used individually or in combination with other substances, subject to prescribed regulatory limits and conditions.
FSSAI emphasised that manufacturers and sellers must follow the applicable standards to ensure consumers receive accurate information about the products they purchase.
๐ช๐ฎ๐ฟ๐ป๐ถ๐ป๐ด ๐น๐ฎ๐ฏ๐ฒ๐น๐ ๐บ๐๐๐ ๐ฏ๐ฒ ๐ฐ๐น๐ฒ๐ฎ๐ฟ
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, companies must comply with specific requirements governing ingredients, product labelling and consumer warnings.
The regulations cover health supplements, nutraceuticals, foods for special dietary use, foods for special medical purposes, products containing added prebiotic and probiotic ingredients, functional foods and novel foods.
FSSAI said the regulations prescribe permissible limits for plant and botanical ingredients and their extracts, whether used separately or in combination.
Warning statements must be prominent, legible and clearly displayed on product labels to help consumers understand relevant precautions and avoid misuse.
The requirements are particularly important for vulnerable consumers who may face greater risks from inappropriate consumption.
๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ถ๐ป๐ฎ๐น ๐ฐ๐น๐ฎ๐ถ๐บ๐ ๐ฝ๐ฟ๐ผ๐ต๐ถ๐ฏ๐ถ๐๐ฒ๐ฑ
The regulator reiterated that nutraceuticals and health supplements cannot be marketed with claims suggesting that they cure diseases or possess medicinal properties prohibited under the regulations.
Food businesses must ensure that their product descriptions, packaging and warning statements comply with the prescribed standards.
The distinction between food supplements and medicines is central to the regulatory framework, which seeks to prevent consumers from being misled about the intended use of such products.
FSSAI has asked food business operators to review their labelling practices and address any deficiencies to avoid regulatory action.
The advisory comes amid the growing availability of nutraceutical and health supplement products, making accurate labelling and clear consumer information important for food safety.