FSSAI’s Crackdown on Fake ORS: Health Risks and the Truth Behind Rehydration

Fake ORS vs Real ORS:

1. What is at stake?

Recently, the Food Safety and Standards Authority of India (FSSAI) issued a landmark directive that targets beverages labelled as “ORS” (Oral Rehydration Solution) but which do not meet the medically correct formulation. In parallel, the Delhi High Court granted an interim stay on key parts of this directive, creating a complex situation in public health terms.

As a physician who treats hepatic disease and supports children and adults through severe illness and recovery, I wish to address: why authentic ORS matters; how these misleading drinks pose health risks (including for liver health); what the recent regulatory action means; and what caregivers and health-practitioners must do.

2. Why standard ORS is a medical cornerstone

The true ORS is one of the great breakthroughs in modern medicine for diarrhoeal disease. According to reports, it was first scaled up in populations in the 1970s and remains essential because it addresses not just fluid loss but electrolyte imbalance and the mechanism of absorption of sodium-glucose co-transport.

In effect: when a patient (especially a child) suffers from diarrhoea and vomiting, the body loses water, sodium, potassium, and bicarbonate (or citrate). The correct ORS replaces these losses, supports absorption of water in the intestine, prevents circulatory collapse, and prevents downstream organ effects.

For the liver (and other organs) this is relevant: severe dehydration or electrolyte disturbances can precipitate acute hepatic stress, may worsen underlying liver disease, or in very ill children result in multisystem involvement including the liver. Although ORS itself doesn’t treat liver disease, failure to manage dehydration properly can lead to worse overall outcomes for vulnerable organs.

3. What the recent regulatory action is

On 14 October 2025, FSSAI issued a directive that no food or drink product that does not meet the WHO-recommended ORS formulation may use the term “ORS” in its brand name, label, advertisement or trademark — whether as a prefix, suffix or standalone.

The directive noted that many drinks labelled as ORS are in fact sugar-rich beverages with inadequate electrolyte content, thereby misleading consumers.

Shortly thereafter, the Delhi High Court granted an interim stay on key parts of the regulation following a petition by a manufacturer (allowing sale or disposal of existing stock) while the matter is adjudicated.

Thus we have a situation where, from a regulatory standpoint, the standard has been set but the enforcement is momentarily paused in parts — leading to a grey area for consumers and health-care providers.

4. Why misleading “ORS” labels are dangerous — especially for children and those with liver or systemic vulnerabilities

a) Children and dehydration

Children under five are especially vulnerable to dehydration from diarrhoea and vomiting. In India, diarrhoea remains a leading cause of mortality in this age group.
When a beverage marketed as “ORS” is in fact a sugar-heavy drink with low electrolyte content:

• It fails to replace sodium/potassium losses adequately.
• The high sugar content can increase osmotic load in the gut, worsening diarrhoea. For example, some of these drinks reportedly contain up to 110–120 g of sugar per litre, far above the roughly 13.5 g per litre in true ORS.
• As a consequence, children may present with worse dehydration, electrolyte derangements (e.g., hyponatraemia, hyperglycaemia), seizures, brain swelling or worse.

b) Impact on liver and systemic health

From a hepatic standpoint:

• In dehydration, hepatic perfusion may drop, which can exacerbate underlying liver disease or cause acute injury in susceptible patients.
• Electrolyte disturbances (for example potassium or sodium derangements) place stress on cellular metabolism in the liver and other organs.
• If children or adults receive an ineffective rehydration drink believing it to be ORS, the delay in proper treatment increases risk of complications: in liver-disease patients this could mean decompensation, in children it may mean more severe illness, hospitalisation, or organ stress.
• Furthermore, sugar-rich drinks may also burden metabolic handling in the liver (though this is secondary) — especially in patients with existing fatty liver, metabolic syndrome or hepatic injury.

Therefore, the mislabelling of ORS is not a benign marketing mistake — it has direct implications for children’s health and for vulnerable adult populations including those with liver disease.

5. Why this matters for parents, caregivers and clinicians

Given the above, the implications are:

• As a clinician, I emphasise that when diarrhoea/vomiting occurs, the first line remains the authentic WHO-recommended ORS (available as sachets in pharmacies) prepared exactly as instructed.
• Drinks marketed as “rehydration”, “hydration solutions” or even bearing “ORS-type” labels should not be substituted unless their composition is known and meets the standard.
• In children, vigilant monitoring of hydration status (capillary refill, urine output, mental status, skin turgor) remains critical — especially if one suspects they have been given a sugar-heavy substitute instead of true ORS.
• For adult patients with liver disease, or any chronic organ disease, similarly ensure that dehydration (even mild) is managed correctly. Misleading products can create added risk.

6. The regulatory and public‐health gap

While the FSSAI’s directive is much welcomed — it addresses a long-standing issue of misleading marketing — the high court stay introduces a complication: the enforcement is not yet absolute. The result is:

• Some beverages that do not meet ORS standards may continue to be sold under “ORS” branding for now.
• Caregivers and clinicians must therefore remain vigilant and not assume any drink labelled ORS is correct.
• It emphasises the need for awareness — both among the public and health-care workers — that the term “ORS” in packaging alone is insufficient guarantee of medical compliance.

7. Doctor’s recommendations

• For children with diarrhoea or vomiting: Purchase WHO-approved ORS sachets (check contents: approximately 2.6 g sodium chloride, 1.5 g potassium chloride, 2.9 g trisodium citrate + 13.5 g glucose per litre of water). Use exactly as directed.
• Avoid reliance on market-drinks simply labelled “ORS” unless the electrolyte and glucose values are clearly stated and match standard.
• For adults (especially with liver or chronic disease): Monitor for signs of dehydration early. Even mild dehydration may trigger disproportionate stress on the liver. Ensure oral rehydration is correct.
• Educate caregivers, parents and patients: The term “hydration drink” or “sports/energy drink” is not equivalent to ORS. A high-sugar beverage may make matters worse.
• For pharmacies and health-care settings: Stock genuine ORS sachets; avoid substituting flavoured or sugar-rich “hydration solutions” in place of ORS.
• For policymakers and hospitals: Advocate for wider awareness campaigns about this regulatory change and the risks of misleading ORS labelling.
• As liver specialists and other physicians: Incorporate hydration-status checking and correct ORS use in protocol — especially for patients undergoing transplant, liver failure, or other organ compromise.

8. Conclusion

In summary: The recent regulatory push by FSSAI is a welcome correction addressing a serious issue — that many products labelled as “ORS” are in fact sugar-laden drinks unsafe for use in dehydration. But the interim stay by the Delhi High Court means the marketplace still has ambiguity.

For clinicians, parents and caregivers — particularly where children or patients with liver/organ disease are involved — the message is clear: do not rely on label alone. Ensure correct ORS formulation, understand the risks of incorrect substitutes, and respond early in dehydration. The health of children and vulnerable adults depends on the correct solutions — not mimics.

As a liver transplant surgeon, I cannot over-emphasise: every time the body is stressed (through dehydration, vomiting, electrolyte imbalance) the liver and other organs are put on the back foot. Using the right ORS is a simple, yet vital, step in protecting organ health and overall recovery.

Stay hydrated. Stay safe. Use genuine ORS.
— Dr. Bipin Vibhute