Remove drinks branded as ORS from shop shelves, e-comm platforms, FSSAI tells states

This direction follows an order by the FSSAI last month banning the use of the term ‘ORS’ in the brand name of any product that does not follow the appropriate formulation recommended by the World Health Organisation (WHO). Pharma multinational Johnson and Johnson’s subsidiary JNTL Consumer Health moved the Delhi High Court asking that it be allowed to sell the existing stocks, which the court denied. This has led to the food regulator now enforcing its October order.

What the FSSAI order says

The officers have been asked to submit an action taken report detailing the inspections conducted, violations detected, and corrective actions that have been initiated.

Significantly, the food regulator has asked the state authorities to ensure that action is not taken against the real WHO-recommended oral formulations, which are essential for the treatment of diarrhoea. These products — usually available as powders that have to be mixed in water — are actually considered to be “drugs” as per the law and fall under the purview of the drug regulator and not the food regulator. The order says, “…it has come to the notice that certain food safety officers are initiating actions, including discontinuing the sale of WHO-recommended Oral Rehydration Salts (ORS) products, even though the regulatory directions issued by FSSAI … apply only to fruit-based beverages and similar products misleadingly marketed as ORS.”

The order further states: “… all … authorities shall ensure that no interference is made with the storage, distribution, or sale of WHO recommended ORS products; enforcement activities shall remain strictly confined to non-compliant food products presented or labelled as ORS, and no sampling, seizure, or lifting of WHO-recommended ORS products shall be carried out. All field officers must exercise due diligence …”

Why fake ORS is a health concern

These “misleading” products have been flagged as a health hazard, considering that they can lead to worsening of dehydration rather than helping with it. ORS — a simple glucose-electrolyte mixture — can reduce deaths and hospitalisations due to acute diarrhoeal diseases, especially in children under the age of five years in whom diarrhoea continues to be a big killer. The WHO-recommended formulation promotes absorption of the water and electrolytes required, whereas any increase in sugar content can actually draw out water from the cells to the gut. It may also worsen diarrhoea itself.

The food regulator initially banned the use of the term ORS by other drinks in April 2022. This relief, however, did not last long. Another order a few months later allowed companies to use the term ORS in their brand names as long as they carried warnings saying that their products were not an ORS solution. This led to many continuing to consume these products, thinking they are ORS, with children turning up at hospitals with worsening dehydration.