FSSAI bans food brands from using 'ORS' tag over misleading claims

Officials say ban comes with food brands not conforming with WHO guidelines, high OTC sales

The Food Safety and Standards Authority of India (FSSAI) has issued a directive stating that no food brand can label a product as oral rehydration salts (ORS), unless the product has been approved by the World Health Organization (WHO).

 

As a result, any violation of the directive would be seen as misbranded and misleading, which is liable for punishment under appropriate provisions of the Food Safety and Standards Act, 2006.

 

Punishment under the act includes monetary penalties ranging from at least ₹300,000 to ₹10,00,000, and a directive to undertake corrective actions.

 

This comes after several food brands such as fruit-based drinks, non-carbonated drinks, and ready-to-drink beverages had been using variations of the term ORS as a prefix of suffix in their brand names.

   

A highly effective treatment for childhood diarrhoea, experts suggest that ORS should only be used when prescribed by a doctor. However, its over the counter (OTC) use is also very prevalent.

 

“Diarrhoea is the third leading cause of childhood mortality in India, and can be managed effectively with ORS. However, many pharmacies across the country sold products labelled as electrolyte products but did not meet the guidelines recommended by the WHO,” an official in the know said.

 

According to data from market research firm Pharmarack, moving annual turnover (MAT, which is previous 12 month’s turnover) for the ORS segment stands at ₹1,232 crore for the October 2024 to September 2025 period. 

 

It adds that this market has grown almost double from ₹648 crore for the same period in 2021.

 

This has majorly been possible due to OTC availability, and emergence of several non-pharmaceutical food-based brands claiming to have the same properties as rehydration salts.

 

“Previous orders of the Centre have also allowed the word ORS to be added to the brand name as a prefix or suffix for food products, leading to proliferation,” the official quoted above added.

 

These provisions allowed products to be marketed along with the warning that the product is not an ORS formula as recommended by the WHO. However, in its directive dated October 14, the food safety regulator had announced withdrawal of all such orders.

 

At the same time, all food business operators have now been asked to remove the word ORS from their food products, whether used as a standalone term or as a prefix/suffix in the product name.

 

“The use of the term ORS in the trademarked name or in naming any fruit-based, non-carbonated or ready-to-drink beverages even when accompanied by a prefix or suffix, constitutes a violation of provisions of the Food Safety and Standards Act, 2006,” the directive added.