FSSAI Bans Misleading Use of ORS Label on Fruit Juices: Dr. Sivaranjani Santosh’s 8-Year Fight Brings Major Regulatory Reform

In a landmark decision dated October 14, 2025, the Food Safety and Standards Authority of India (FSSAI) issued a strict directive prohibiting the use of the term “ORS” (Oral Rehydration Solution) on any fruit juices, non-carbonated beverages, or other food products unless they strictly conform to the World Health Organization (WHO) recommended formula FSSAI order details. This crucial regulation aims to end widespread consumer trick caused by sugar-loaded drinks misbranded as ORS, which pose significant health risks, especially to children suffering from dehydration due to diarrheal diseases.

Why This Ban Was Needed

Oral Rehydration Solution (ORS) is a scientifically validated medical treatment prescribed for dehydration caused by diarrhea, particularly in children. However, the Indian market had become flooded with fruit juices and other beverages labeled “ORS” without conforming to the WHO formula, which includes precise concentrations of sodium chloride, potassium chloride, sodium citrate, and dextrose. Many of these drinks contained dangerously high sugar levels, up to ten times the medically recommended amount, misleading vulnerable populations about their effectiveness as per WHO ORS formulation criteria and Financial Express report

This issue prompted a rigorous and persistent public health campaign led by Hyderabad-based pediatrician Dr. Sivaranjani Santosh. Over an eight-year period, she tirelessly advocated against the misuse of the ORS label, utilizing social media education, government petitions, and ultimately a Public Interest Litigation (PIL) in Telangana High Court India Today on Dr. Santosh’s campaign Economic Times background on Dr. Santosh.

The Regulatory Directive

On October 14, 2025, FSSAI revoked all previous permissions that allowed companies to use the “ORS” term even with disclaimers like “This product is NOT an ORS formula as recommended by WHO.” Going forward, only those products that strictly follow the WHO recommended composition can legally use the ORS label. This includes the removal of the term “ORS” from all other food and beverage products, whether used alone, as a prefix or suffix, or as part of trademarks FSSAI’s official notification Business Standard article.

The FSSAI also emphasized the legal basis of this decision, citing violations under the Food Safety and Standards Act, 2006 concerning misleading advertisements, labeling, and deceptive branding practices. Enforcement teams across states have been directed to ensure strict compliance and penalize offenders The Hindu article on enforcement.

What Is The WHO Recommended ORS Formula?

The ORS prescribed by WHO contains specific electrolytes and glucose amounts optimized for effective rehydration without harming the patient. The formula consists of 2.6 g sodium chloride, 1.5 g potassium chloride, 2.9 g sodium citrate, and 13.5 g dextrose per liter of water, resulting in an osmolality of 245 mOsm/L WHO guidelines. Beverages labeled as ORS but containing up to 120 g of sugar per liter are not just ineffective but can worsen dehydration, especially in children PLOS ONE on hydration therapy.

Dr. Sivaranjani Santosh’s Campaign

Dr. Sivaranjani Santosh took this issue from social media advocacy to legal battlefield. Despite initial hurdles, including a temporary regulatory relaxation allowing disclaimers, her persistence ended in the recent strict FSSAI directive. She highlights the moral imperative for accurate product labeling, underscoring that families deserve real, life-saving ORS not sugary beverages posing as medicine India Today exclusive on Dr. Santosh’s fight.

The Public Health Impact

Diarrhea remains a leading cause of mortality in Indian children under five. Accurate ORS usage reduces the need for hospital admissions and preserves child lives JAMA Network on diarrhea treatment in India. The FSSAI ban allows doctors and caregivers to restore trust in the therapy, ensuring life-saving medicines are not confused with harmful substitutes Free Press Journal on public awareness.

While FSSAI’s directive is a major victory, Dr. Santosh stresses the need for broad-based public education on correct ORS preparation and use. Clear instructions, widespread awareness, and enforcement of labeling rules will be decisive in ensuring compliance and reducing childhood dehydration deaths Deccan Chronicle on implementation challenges.