From a regulatory standpoint, nutraceuticals currently exist in the twilight zone, between foods and medicines. And this grey zone has benefitted some brands. In India, nutraceutical regulations are evolving, and are in flux between the Food Safety and Standards Authority of India (FSSAI) and the Central Drugs Standard Control Organisation (CDSCO).
However there may be an end in sight finally to this uncertainty. FSSAI spokespeople at this year’s Global NutraConnect Summit 2026, organised by Health Foods and Dietary Supplements Association (HADSA), indicated that they expect nutraceuticals to remain under their watch. There was a collective sigh of relief and applause from the audience.
But their celebrations may be premature. The FSSAI can be as tough as the CDSCO. Consider the FSSAI’s evolving stand and crackdown on the misuse of the Oral Rehydration Solution (ORS) nomenclature. The FSSAI’s previous orders dated July 14, 2022 and February 2, 2024 had permitted the use of the term ‘ORS’ on food labels as part of the trademark with a prefix or suffix in the product name, subject to the declaration/warning: “The product is NOT an ORS formula as recommended by WHO.”
But on October 15, 2025, FSSAI clarified that, upon further review, the use of the term ‘ORS’ in the trademarked name or in the naming of any food product otherwise-whether fruit-based, non-carbonated, or ready-to-drink beverages-even when accompanied by a prefix or suffix, constitutes a violation of the provisions of the Food Safety and Standards Act, 2006 and the regulations. The communication from FSSAI goes on to state that ‘such practices are misleading to consumers by way of false, deceptive, ambiguous, and erroneous names/label declarations’, and are in contravention of various sections of the Food Safety and Standards Act, 2006.
The impact on sales of brands that can no longer use the ORS branding is clear. As per PharmaTrac data, India’s ORS sales value dipped 26 per cent, from Rs 115 crore last March to Rs 85 crore this March. This is a clear impact of FSSAI’s regulations, as brands were forced to withdraw mislabelled products, and reformulate as per WHO’s ORS guidelines. Legacy ORS brands will have to keep up with newer entrants, who have positioned their ORS-based brands as science-backed WHO-approved rehydration solutions.
The writing on the wall is clear. Comply or move out. The regulator has teeth and is not afraid to bite. The importance of regulating the nutraceutical sector increases as medicines for chronic health conditions need to be supported with specialised nutrition for better long term health outcomes.
For example, the recent avalanche of generic weight loss shots has triggered product launches in the diabetes and obesity nutrition space. As specialised nutrition becomes a vital part of various treatment regimes, stronger regulatory oversight to guard against mislabelling and misleading claims is crucial to protect consumer/patient safety.
VIVEKA ROYCHOWDHURY
Editor
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