FSSAI Directs Nutraceutical Makers to Ensure Mandatory Warning Labels on Botanical Products

The Food Safety and Standards Authority of India (FSSAI) has issued a directive requiring nutraceutical and health supplement manufacturers to ensure adherence to mandatory labelling and warning statement requirements for products containing plant and botanical extracts. The regulatory body has instructed food business operators to review their existing product labels for compliance, noting that violations will result in stringent actions, including license suspension and the imposition of penalties.

According to the regulations, specific botanical ingredients require designated cautionary text. For example, products utilizing neem fruit extracts or Gandiva extracts must display the warning statement “Not recommended for children below 5 years.” Similarly, formulations containing Papita leaf or juice are mandated to carry the warning “Not recommended during pregnancy.”

In a recent advisory, the FSSAI stated that several food business operators manufacturing and selling nutraceuticals, health supplements, or foods for special dietary use have failed to follow prescribed labeling requirements and warning statements for products containing plant-based ingredients.

The regulatory framework is governed by 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. These rules set compliance standards for permissible limits of plant and botanical ingredients and their extracts, either individually or in combination. The regulations also strictly prohibit any medicinal claims or suggestions that a product can cure diseases.

The FSSAI advisory emphasizes that warning statements must be prominent, legible, and clear to prevent misuse, particularly among vulnerable populations. The required warnings are specified for individual plants or extracts based on known side effects or contraindications.

Manufacturers have been directed to ensure their product labels indicate the specific plant part used and include immediate compliance with required disclaimers, cautionary statements, or warnings based on ingredient characteristics.

The regulator concluded that any failure to comply with these labeling mandates will render the food business operator liable for regulatory action. This includes the potential suspension or cancellation of licenses and the imposition of penalties under the provisions of the Food Safety and Standards Act, 2006.

"The recent directive from the FSSAI underscores the critical importance of regulatory compliance for startups and established businesses operating in the health supplement and nutraceutical sectors. As consumer awareness grows, regulatory oversight on product labeling and safety disclaimers is becoming increasingly strict. Founders and operators must proactively review their product formulations and packaging to align with statutory requirements. Ensuring transparency not only protects vulnerable consumer segments but also safeguards businesses from severe penalties and operational disruptions such as license suspensions." — Dr. Shishir Gupta, Founder & CEO, StartupLanes