“India’s Food Regulator FSSAI Draws the Line: Only WHO-Approved Formulas Can Be Called ORS”
In a significant regulatory move, the FSSAI has issued a directive that all food and beverage manufacturers must remove the term “ORS” (Oral Rehydration Solution/Salts) from product names, trademarks and labels unless the product meets the strict formula approved by the World Health Organization (WHO
The move comes after long-standing concerns that many beverage products marketed with “ORS” in their name did not adhere to the recognized ORS formula — a situation that regulators say has the potential to mislead consumers and even worsen health‐outcomes.
What the directive says
- As of the order, any food business operator (FBO) across states, Union Territories and under central licensing must cease using “ORS” in product labelling or naming, whether as a standalone term, with a prefix/suffix, or embedded in a trademark.
- The FSSAI emphasises that the use of “ORS” in the name of beverages (fruit-based drinks, ready-to‐drink, non-carbonated) that don’t meet the WHO‐approved ORS standard is a violation of the Food Safety and Standards Act, 2006 (FSSA) and its regulations.
- Previously, in July 2022 and February 2024, the regulator had allowed use of “ORS” in product names provided there was a disclaimer: “The product is NOT an ORS formula as recommended by WHO.” That permission has now been withdrawn after review.
- The FSSAI notes that such misuse of the term “ORS” can mislead consumers through false or ambiguous labelling and make products mis-branded, thus attracting penalties under Sections 52 and 53 of the FSSA.
Why this matters: the background & implications
What is genuine ORS?
An ORS is a medically-approved formulation (of specific salts and sugars dissolved in water) to treat dehydration — especially due to diarrhoea, vomiting or other causes of fluid loss. The WHO has defined the exact mixture and use-case. 
What was the issue?
Over the years, numerous packaged drinks have used “ORS” in their name or branding — often flavoured or sugar‐rich beverages marketed as electrolyte or hydration drinks. In many cases, these did not adhere to the approved ORS composition (lower salts, higher sugar) and yet may have given consumers the impression they were medically appropriate ORS solutions. Experts say this can be dangerous (especially for vulnerable patients) since high sugar or incorrect electrolyte ratios may worsen dehydration or related medical conditions.
Who pushed for change?
A key role has been played by Dr Sivaranjani Santosh, a paediatrician from Hyderabad, who for nearly eight years campaigned against the misuse of “ORS” in product labelling. Her advocacy collected evidence of children and patients being given mis‐labelled “ORS” drinks that were not medically appropriate, which helped push the regulator to act.
Implications for industry
- Beverage companies that included “ORS” in product names will need to re-label, rename or reformulate — or remove the term altogether.
- Retailers and distributors may face compliance scrutiny.
- The decision reinforces that using medically-charged terminology in food/beverage branding (without meeting the standard) is risky from a regulatory and liability standpoint.
- From a consumer perspective, less confusion: one key label (“ORS”) is now reserved for medically-appropriate formulations.
Implications for public health
- Patients needing true ORS (e.g., children with diarrhoea, patients with dehydration) are less likely to be misled by commercial drinks.
- Encourages better hygiene around dehydration management: e.g., genuine ORS when required, not substitutes with high sugar that may worsen outcomes.
- A broader step in ensuring food & beverage labelling meets clarity, transparency and safety.
Challenges & What to watch
- Enforcement: While the directive is clear, actual monitoring at retail level, especially in remote/low-regulation states, will be key.
- Industry push-back: Some brands may argue trademark rights or prior existing use; how that plays out in court or regulatory forums remains to be seen.
- Consumer awareness: Even with correct labels, consumers need to understand what ORS is, when it’s needed, and when a regular “hydration drink” is not a substitute.
- Formulation oversight: Some manufacturers may choose to reformulate to meet ORS standards — but that will demand regulatory reviews/approvals, labelling changes etc.
- Broader precedent: This move may inspire further scrutiny of other terms (e.g., “health drink”, “nutrient solution”, etc.) used in ways that can mislead.
Key takeaway
The FSSAI’s decision to ban the use of “ORS” in product naming unless it meets WHO-approved standards is a landmark step in food regulation and consumer protection in India. It underscores that medical‐grade terminology cannot be casually applied in food/beverage branding without meeting the underlying science. For consumers, it means clearer labels; for industry, a stricter compliance bar; for public health, a reduction in misleading branding that could harm vulnerable populations.

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