FSSAI Prohibits ORS Labeling on Food Products

FSSAI Prohibits ORS Labeling on Food Products

Why in News?

The Food Safety and Standards Authority of India (FSSAI) announced a strict directive to prohibit food and beverage companies from labeling their products as ‘ORS’. This decision aims to protect consumers from misleading claims, maintaining transparency and public trust.

Highlights of the FSSAI Directive on ‘ORS’ Labelling

• FSSAI has issued new directives on 14 October 2025 and issued clarifications & withdrawal of earlier orders permitting Oral Rehydration Solution (ORS) usage in brand names.
• According to the FSSAI directives, all Food Business Operators (FBOs) must remove the term “ORS” from packaging, branding, advertisements, and trademarks. This applies whether “ORS” appears alone, as a suffix, prefix, or inside a brand name. Even fruit drinks, ready-to-drink beverages, or electrolyte drinks are covered.
• The directive cites Sections 52 and 53 of the Food Safety and Standards Act, 2006 for penal action against violations. Products misbranded or making deceptive claims may face fines and mandatory corrective steps.
• FSSAI said that only formulations which meet World Health Organisation (WHO) standards can justifiably use the ORS label from confusing medical claims. 

What Triggered the Ban on ‘ORS’ Labeling

• • Regulatory Scrutiny: The debate over the misuse of the term “ORS” started gaining national attention in 2022 when a Public Interest Litigation (PIL) was filed before the Telangana High Court. The petition highlighted that several popular beverage brands were using “ORS” on their labels even though their products did not meet WHO formulation standards. The court directed the FSSAI to investigate the matter and issue appropriate guidelines.

• Misleading Marketing: During 2023–2024, the Indian market saw a rapid rise in drinks using “ORS” on their packaging. Brands promoted fruit-based and flavored electrolyte beverages as health-restoring or recovery drinks. Industry reports from NielsenIQ India showed that ORS-branded beverages registered a growth of nearly 42 percent in 2023. This aggressive marketing prompted concerns.

• Rising Health Risks: Consumers often could not differentiate between pharmaceutical ORS packets and commercial drinks with similar labeling. Several public health experts warned that dehydration cases, especially among children and rural populations, could worsen if people used such drinks as substitutes for real ORS solutions. In 2024, the Indian Academy of Paediatrics (IAP) reported that the misuse of unapproved drinks was common in small clinics and during summer months when dehydration cases peak.

What is Oral Rehydration Solution (ORS)?

• About: Oral Rehydration Solution or Salts (ORS) is a simple medical formulation used to treat dehydration caused by diarrhoea, vomiting, heat exhaustion, or other illnesses. It contains a balanced mixture of glucose and essential salts such as sodium chloride, potassium chloride, and citrate. It works on the principle of sodium-glucose co-transport, which means that when glucose is absorbed in the intestine, it carries sodium and water with it. The World Health Organization (WHO) and UNICEF recognize ORS as one of the most effective and affordable medical solutions.

• Development: The concept of ORS was first explored in the 1960s, when doctors discovered that adding glucose to a salt solution improved water absorption in patients with cholera. The breakthrough came during the Bangladesh cholera epidemic of 1968–1971, when researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) and Indian scientists at Christian Medical College, Vellore, tested oral rehydration therapy successfully. 

• Benefits: ORS is one of the simplest and most life-saving treatments in medical history.

• It prevents severe dehydration and restores fluid balance within hours. It can be easily prepared by dissolving one standard packet in one litre of clean drinking water. 

• • • The solution helps the body replace lost fluids and electrolytes quickly. 

• It is safe for infants, children, adults, and the elderly. According to WHO estimates, proper ORS use prevents 1.5 million child deaths every year globally. 

• ORS is inexpensive and does not require medical supervision, which makes it ideal for low-income regions. 

• It can be stored for long periods and distributed during emergencies like floods or disease outbreaks.

• In 2024, India distributed more than 600 million ORS packets across states to combat dehydration in children under five years. 

• Clinical studies show that ORS reduces stool output by 25% and the duration of diarrhoea by about 20% compared to untreated patients. 

• Limitations: ORS is also ineffective if mixed incorrectly. Adding too much or too little water can change the salt concentration, leading to serious health issues like hypernatremia or hyponatremia. 

WHO Standards in ORS Formulation

• The World Health Organization (WHO) created the first global standard for Oral Rehydration Salts (ORS) in 1978 to reduce dehydration-related deaths caused by diarrhoeal diseases. 
• The WHO-recommended ORS contains a specific balance of salts and glucose. It includes sodium chloride (2.6 g), glucose anhydrous (13.5 g), potassium chloride (1.5 g), and trisodium citrate dihydrate (2.9 g) per 1 litre of water. This creates a total osmolarity of 245 mOsm/L, which is lower than earlier formulations used in the 1980s.
• It is included in the WHO Model List of Essential Medicines, showing its global public health importance. 
• The formula was developed after extensive research during cholera outbreaks in the 1960s and 1970s, which was later updated in 2003 after clinical trials.
• The revised formula is now followed in more than 90 countries, including India, and is used in all national health programs like the National Health Mission (NHM) for diarrhoea control.
• India adopted the WHO ORS formulation through the Ministry of Health and Family Welfare under the National Diarrhoeal Disease Control Programme (NDDCP).