Hyderabad (Telangana) : In a landmark move for consumer safety, the Food Safety and Standards Authority of India (FSSAI) has prohibited food brands from using the term ‘Oral Rehydration Salts’ (ORS) or ‘ORS’ on any product that does not strictly follow the World Health Organisation (WHO) formulation standards. The directive, issued on October 14, mandates the immediate withdrawal of all previous permissions granted to food business operators (FBOs) for using ‘ORS’ in conjunction with brand names.

This regulation rescinds two prior orders dated July 14, 2022, and February 2, 2024, which had temporarily allowed the use of ‘ORS’ in trademarks with disclaimers stating the product was “Not an ORS formula as recommended by WHO.” The FSSAI followed up on October 15 with a detailed clarification, stating that using ‘ORS’ in the name of any beverage—whether fruit-based, non-carbonated, or ready-to-drink—violates the Food Safety and Standards Act, 2006. The regulator emphasised that such labelling misleads consumers through false, deceptive, ambiguous, and erroneous claims.

A paediatrician’s decade-long fight

The regulatory intervention stems from the persistent efforts of Dr. Sivaranjani Santosh, a Hyderabad-based paediatrician, who has campaigned against sugar-rich beverages falsely marketed as ORS for nearly a decade. In 2022, she filed a Public Interest Litigation (PIL) in the Telangana High Court, challenging the sale of products that claimed to be ORS but did not meet WHO-recommended electrolyte and glucose standards.

Dr. Sivaranjani highlighted that several companies marketed fruit juices and sweetened beverages under the guise of ORS, posing serious health risks, particularly for children and diabetic patients. Her complaints reached the Ministry of Health and Family Welfare, prompting both judicial and regulatory scrutiny.

Court and FSSAI actions

The Telangana High Court directed responses from both the FSSAI and the Drug Controller General of India, recognising the public health implications of misleading ORS claims. Subsequently, on April 8, 2022, FSSAI issued its first directive restricting the use of ‘ORS’ in food labels and advertisements.

However, in July 2022, the FSSAI temporarily relaxed the restriction following a writ petition by several companies, allowing products with registered trademarks to continue production until a final decision by the Controller General of Patents, Designs, and Trademarks. The latest October 14 directive now completely nullifies the previous permissions, mandating full compliance with WHO standards.

WHO-approved ORS vs sugar-loaded imitations

According to WHO, a standard oral rehydration solution has a total osmolarity of 245 mOsm/L, containing 2.6 grams of sodium chloride, 1.5 grams of potassium chloride, 2.9 grams of sodium citrate, and 13.5 grams of dextrose anhydrous per litre of water.

In contrast, several commercially marketed ORS beverages contain up to 120 grams of sugar per litre, with 110 grams being added sugar. Their electrolyte balance is inconsistent with WHO norms, providing only 1.17 grams of sodium, 0.79 grams of potassium, and 1.47 grams of chloride per litre, potentially compromising hydration efficacy and safety.

Paediatrician reflects on the victory

Reflecting on the outcome, Dr. Sivaranjani described the FSSAI order as the result of years of persistence and public support. She said, “It was a war. Eight years of battle, three years of filing PILs, and four to five years of fighting indifference. This victory belongs not to one person, but to people’s power—all the doctors, advocates, moms, and influencers who stood with me. I stood steadfast, and we won.”

The FSSAI directive is being hailed as a major step toward protecting consumers, especially children, from misleading labelling practices and ensuring that only scientifically validated ORS formulations are promoted in the market.