FSSAI warns nutraceutical firms over labelling violations, threatens action for non-compliance

FSSAI is requiring food companies to correct their product labels and follow all mandatory warning rules. The warning targets businesses making or selling nutraceuticals, health supplements, and related specialised foods. The regulator has expressed concern that several Food Business Operators are not following these requirements.

The required action includes complying with labelling rules for plant and botanical ingredients and their extracts. Labels must also carry the prescribed warning statements. These warnings must be prominent, legible, and clear, so consumers can notice and understand them before using the products.

FSSAI issued its advisory through a social media post on Monday. It warned that companies could face action if they continue not to comply. The rules apply under the 2016 regulations covering several non-conventional food categories, while also prohibiting medicinal claims or suggestions that a product can cure disease.

Nutraceuticals and health supplements are products regulated as non-conventional foods under India’s 2016 rules. They include products intended to supplement diets or provide particular nutritional or health-related functions. The article groups them with specialised foods, such as food for special dietary use and food for special medical purpose.

Ordinary foods are generally consumed as part of a regular diet, while these regulated products are presented for specific nutritional, health, dietary, or medical-purpose uses. They may contain plant or botanical ingredients and extracts. The article does not provide a detailed legal definition of each term, so these distinctions use established general knowledge alongside its description.

They are also different from medicines because the regulations prohibit medicinal claims or suggestions of disease cure. In other words, a product may be regulated as food while serving a specialised nutritional purpose, but it must not be presented as a disease-treating medicine.

India’s regulations require these products to follow mandatory labelling requirements and warning statements. The requirements specifically address plant and botanical ingredients and their extracts, whether used alone or combined with other ingredients. The label must present the relevant information in a way consumers can notice and understand.

FSSAI says warning statements must be prominent, legible, and clear. This means they should not be hidden, too small, or difficult to read. The regulations also set compliance standards for permissible limits of plant and botanical ingredients and their extracts. Companies must therefore address both the product’s composition and its label.

The rules also prohibit medicinal claims or suggestions that a product can cure disease. FSSAI issued the advisory because several Food Business Operators were not following these requirements. The regulator warned that action could be taken if companies fail to comply with the labelling and warning provisions.

India’s Food Safety and Standards regulations from 2016 cover seven categories of non-conventional foods. The article identifies these as health supplements, nutraceuticals, food for special dietary use, food for special medical purposes, food with added prebiotic and probiotic ingredients, functional food, and novel food.

This broad coverage matters because FSSAI’s labelling advisory is not limited to one type of product. It applies across these regulated categories when companies use plant or botanical ingredients and their extracts. The regulations set standards for permissible limits and prescribe warning statements for relevant products.

The article says several Food Business Operators in these areas are not adhering to mandatory requirements. FSSAI has therefore reminded them to comply. It also warns that companies may face action if they fail to follow the rules, including the requirements for clear warnings and the prohibition on medicinal or disease-cure claims.

India’s regulations set compliance standards for the permissible limits of plant and botanical ingredients and their extracts. These standards apply whether the ingredients are used alone or in combination with other ingredients. The rules also require appropriate warning statements on relevant products.

The article does not explain the scientific basis for each limit or identify particular plants. It does state that the labelling system is designed to prevent misuse. Warnings must therefore be prominent, legible, and clear, rather than buried in small or difficult-to-read text. Limits and warnings work together as regulatory safeguards.

FSSAI highlighted these requirements because several Food Business Operators are not following them. The concern is especially important for vulnerable populations, whom the regulator specifically mentions. Companies selling covered products must comply with the ingredient standards and display the required warnings. FSSAI has warned of action if they do not meet these obligations.

The clearest risk identified by the article is misuse. FSSAI says warning statements are required to help prevent misuse, especially among vulnerable populations. If warnings are missing, unclear, or difficult to read, consumers may not notice important information before using a product.

For example, a product containing plant or botanical ingredients might carry a required warning. If that warning is hidden or illegible, the consumer may use the product without seeing the regulator’s caution. The article does not identify a specific ingredient, health effect, or consumer injury. It also does not describe a particular misuse scenario.

FSSAI’s rules require warnings to be prominent, legible, and clear for this reason. Several Food Business Operators were reportedly not following the requirements, so the regulator issued an advisory. The immediate compliance issue concerns companies, while the stated consumer concern is preventing misuse, especially among vulnerable populations.

FSSAI’s regulations prohibit medicinal claims and suggestions that a product can cure disease. This keeps products in the regulated food categories described by the article from being presented as medical treatments. The rule applies to nutraceuticals, health supplements, and other covered non-conventional foods.

For example, a company may sell a product containing a plant extract, but its label cannot suggest that the product cures a disease. It must instead follow the applicable ingredient limits, labelling requirements, and warning statements. The article does not provide a named product or a specific prohibited claim.

The article does not give a detailed explanation for the prohibition. In general, separating food claims from medicine claims helps prevent consumers from confusing a food product with a proven disease treatment. FSSAI’s advisory reinforces this boundary while warning companies that non-compliance with the regulations may lead to action.