Only WHO-Compliant Formulas Can Use ORS Tag: FSSAI Cracks Down on Misleading Beverage Labels

The order marked under file number RCD-15001/6/2021-Regulatory-FSSAI—comes after an eight-year-long campaign led by pediatrician Dr Sivarajanani, who fought against the rampant misuse of the “ORS” label on commercial beverages that did not meet WHO criteria.

This directive overturns the earlier FSSAI orders issued in July 2022 and February 2024, which had placed strict labeling conditions on products using the term “ORS.” Those regulations had required manufacturers of non-WHO-compliant formulations to display a prominent front-of-pack disclaimer reading, “The product is NOT an ORS formula as recommended by WHO,” in order to safeguard consumers from misleading claims.

The FSSAI directive states,

"It is hereby 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 made thereunder."

Dr Sivarajanani’s relentless pursuit, spanning eight years of advocacy, three years of filing Public Interest Litigations (PILs), and four to five years of battling official apathy, culminated in this decisive regulatory action.

“It was a war. Eight years of battle, three years of filing PILs, and four to five years of fighting indifference. We have won—no one can use ‘ORS’ on their label unless it’s a WHO-recommended formula," the doctor expressed.

Earlier, the Medical Dialogues Team had reported that Dr Santosh previously had written to the Central Drugs Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) in this regard and already had filed a Public Interest Litigation (PIL) before the Telangana High Court.

Speaking to Medical Dialogues, Dr Sivaranjani had explained that ORSL, which is an energy drink, contains added sugar- around 10 times the recommended amount by the World Health Organization (WHO).

For years, several beverage brands had marketed flavored electrolyte drinks and fruit-based beverages as “ORS,” allegedly exploiting consumer trust in a medically recognized term. Such misbranding blurred the line between medical formulations and commercial beverages, posing public health and consumer protection risks.

According to FSSAI’s order dated October 14, 2025, no company can use “ORS” on product labels unless the formula fully matches the WHO-prescribed standard.

FSSAI’s latest order firmly restores that distinction, ensuring that only scientifically validated, WHO-aligned formulations can bear the “ORS” label. The decision aligns with FSSAI’s mandate under the Food Safety and Standards Act to prevent false, misleading, or deceptive claims in the food and beverage industry.

Following the order, FSSAI has directed all enforcement divisions and State food authorities to monitor compliance and initiate strict regulatory action against violators. Manufacturers using the “ORS” term on labels will be required to reformulate their products or remove the misleading terminology immediately.

Beverage manufacturers will be required to remove or revise any misleading ‘ORS’ labeling unless their products conform exactly to WHO-recommended ORS composition. FSSAI has instructed its enforcement divisions to monitor compliance and take strict regulatory action against violators.

To view the official order, click the link below:

https://medicaldialogues.in/pdf_upload/ors-fssai-304978.pdf