1. Introduction

The present case arises from a public health controversy concerning the marketing and sale of beverages branded as “ORSL” (Oral Rehydration Salt Liquid) in India. These products were being sold in pharmacies and retail outlets as if they were medically approved oral rehydration solutions (ORS), despite not conforming to the World Health Organization (WHO)-prescribed composition for ORS.

The issue gained national attention when Dr. Sivaranjani Santosh, a Hyderabad-based paediatrician, challenged the role and conduct of the Food Safety and Standards Authority of India (FSSAI) in handling the matter, alleging leniency and regulatory inconsistency in enforcing its ban on such misleading products.

2. Background of the Case

Dr. Sivaranjani Santosh had been campaigning for several years against the marketing of high-sugar beverages misleadingly branded as “ORS” or “ORSL.” These products contained excess glucose and inadequate electrolytes, thereby posing potential health risks to children and patients suffering from dehydration or diarrhoeal conditions.

Following sustained medical and public pressure, the FSSAI issued an order on 15 October 2025, prohibiting all manufacturers and marketers from using the term “ORS” (or any similar expression) in product names, trademarks, or labelling unless the formulation strictly adhered to the WHO’s approved ORS composition.

However, within days of the ban, controversy erupted after reports suggested that FSSAI had granted permission to certain companies (notably JNTL Consumer Health Pvt. Ltd., an Indian subsidiary of Kenvue) to dispose of existing ORSL stocks, allegedly through a “stay” or interim relief.

3. The Contention

(a) Dr. Sivaranjani Santosh’s Allegation

Dr. Santosh publicly criticized FSSAI, alleging that despite banning non-compliant ORS-labelled beverages, the authority had “secretly permitted” their continued disposal and sale under the guise of stock clearance. She termed this a “national shame”, arguing that the regulator’s actions diluted the ban and endangered public health, especially for children.

Her contention was that:

• The disposal permission (if any) was inconsistent with the Food Safety and Standards Act, 2006, which mandates that unsafe or misbranded food products must be withdrawn from circulation immediately.
• The alleged consent for disposal violated Section 26(2)(ii) of the FSSA, which prohibits misleading representation of food, and Section 52, which penalizes such misbranding.
• Allowing sale of remaining stocks undermined the object of the October 15 ban and constituted administrative inconsistency and negligence in public health regulation.

(b) FSSAI’s Response

The FSSAI issued a public clarification on 23 October 2025, categorically denying the allegations. It asserted that:

• It had not granted any permission or consent for the sale, disposal, or clearance of ORSL stocks.
• Claims that it allowed disposal were “false and misleading.”
• The order of 15 October 2025 remained fully effective, and enforcement authorities were directed to ensure compliance across the country.
• The supposed “stay” order cited in media reports pertained to a judicial proceeding (W.P.(C) 16217/2025) filed by JNTL before the Delhi High Court, and not to any administrative consent by FSSAI.

4. Legal Framework

The dispute touches upon multiple legal provisions under the Food Safety and Standards Act, 2006 and its subordinate regulations:

1. Section 3(1)(zz) – Defines “misbranded food” as any food whose labelling, presentation, or advertisement is misleading or false.
2. Section 26(2) – Places the duty of ensuring compliance with standards upon food business operators (FBOs).
3. Section 52 – Prescribes penalties for misbranding (up to ₹3 lakh).
4. Section 63 – Penalizes manufacturing or selling food in contravention of FSSAI orders.
5. Food Safety and Standards (Labelling and Display) Regulations, 2020 – Prohibit false or deceptive representations on food labels.

Under the WHO-UNICEF guidelines, a medically valid ORS must contain per litre:

• Sodium chloride – 2.6 g
• Potassium chloride – 1.5 g
• Trisodium citrate – 2.9 g
• Glucose – 13.5 g

The “ORSL” drinks, on the other hand, reportedly contained excess sugar and inadequate electrolytes, thereby qualifying as non-medical beverages, not therapeutic rehydration solutions.

5. Judicial Proceedings

The manufacturer, JNTL Consumer Health Pvt. Ltd., filed a writ petition before the Delhi High Court (W.P.(C) No. 16217 of 2025), challenging the FSSAI’s order of 15 October 2025.
It sought interim relief to allow sale or disposal of existing stocks, contending that:

• The term “ORSL” was a registered trademark long in use and distinct from “ORS.”
• The FSSAI’s directive amounted to retrospective application of a ban without adequate notice.
• The existing stocks, already in the supply chain, would cause commercial loss if immediately destroyed.

The High Court reportedly issued a limited stay, restraining immediate enforcement of the ban against the petitioner’s stocks until the next hearing, directing FSSAI to consider representations.

This partial stay order was interpreted in the media as FSSAI’s “permission” for disposal, prompting Dr. Santosh’s criticism. FSSAI clarified that the stay was a court’s interim order, not an administrative approval by the regulator.

6. Issues Raised

1. Whether beverages marketed as “ORSL” violate the FSSAI’s labelling and composition regulations and constitute misbranded food under the Food Safety and Standards Act, 2006.
2. Whether FSSAI, as the statutory regulator, acted within its powers by imposing the October 15 ban.
3. Whether the subsequent stay order justifies temporary non-enforcement or constitutes arbitrary leniency towards a manufacturer.
4. Whether misleading labelling of “pseudo-ORS” beverages violates the right to health and consumer protection principles under Article 21 and related jurisprudence.

7. Arguments

For Dr. Sivaranjani Santosh

• The regulator’s duty is to protect public health, not to accommodate commercial considerations.
• Allowing even limited sale or disposal of non-compliant products undermines consumer trust and violates the spirit of the FSSA.
• Misrepresentation of high-sugar beverages as medical ORS can exacerbate dehydration, especially in children.
• Regulatory ambiguity amounts to administrative arbitrariness and failure of statutory duty.

For FSSAI

• The FSSAI’s directive banning misuse of “ORS” remains valid and binding.
• It has not authorized any sale or disposal; any temporary suspension is judicial, not regulatory.
• FSSAI is actively pursuing nationwide enforcement against all misbranded ORS-labelled products.
• Misinterpretation of the High Court’s stay cannot be equated with regulatory misconduct.

For the Manufacturer

• The company’s product “ORSL” is a proprietary beverage, not a therapeutic ORS, and its label already carries nutritional information.
• The product’s branding existed before the new directive, thus sudden enforcement without transition period violates principles of natural justice.
• Interim disposal of existing stocks is reasonable to prevent commercial waste and loss.

8. Court’s Observations (as reported)

The Delhi High Court, in its interim observations, directed that:

• The matter requires examination of the scope of the FSSAI’s directive and the distinction between “ORS” and “ORSL” as commercial labels.
• FSSAI shall file a detailed response explaining the scientific and legal basis of the ban.
• Until further orders, enforcement against JNTL’s existing stocks would be temporarily suspended, subject to compliance with disclosure norms.

Final adjudication remains pending.

9. Analysis

This case raises a significant intersection of public health, consumer protection, and administrative law.

The FSSAI’s October 2025 order is in line with its statutory duty to ensure that food products are safe, correctly labelled, and not misleading. However, the controversy highlights the tension between regulatory enforcement and judicial interim relief.

From a public health perspective, Dr. Santosh’s campaign underscores the vital role of medical professionals in exposing unsafe or misleading products. The case also draws attention to corporate branding practices that exploit medical terminology to market consumer beverages.

The legal question of whether a registered trademark like “ORSL” can be restricted due to public health grounds will test the balance between intellectual property rights and consumer safety.

10. Conclusion

The ORSL controversy epitomizes the challenges in enforcing food safety standards in India where regulatory oversight meets judicial scrutiny and corporate influence.

While FSSAI’s denial of any “permission” for disposal clarifies its official stance, the pending judicial review will determine the extent of regulatory powers over misleading commercial terminology and product clearance.

Dr. Sivaranjani Santosh’s advocacy has brought to national attention a critical issue of medical misbranding and child health safety, reinforcing that public health must override commercial convenience.

The final outcome of this case will likely set an important precedent for how India balances consumer rights, food labelling integrity, and industry compliance under the Food Safety and Standards Act, 2006.