Delhi HC Pressures FSSAI in ORS Mislabeling Case, Threatens Production Ban

New Delhi – The Delhi High Court has expressed strong disapproval over the Food Safety and Standards Authority of India's (FSSAI) delay in addressing the issue of beverage companies using the medical term 'ORS' on products that do not conform to the World Health Organisation (WHO) formula. In a recent hearing, the Court admonished the FSSAI for its slow pace, clarifying that a previous consent order was intended to facilitate swift regulatory action, not to permit continued manufacturing of the misleadingly labeled products. The Court has now threatened to issue a direct restraining order against manufacturers if the FSSAI fails to make a final decision by the end of the week.

The sharp remarks from the bench underscore the escalating legal battle over the use of "Oral Rehydration Salt" (ORS) as a brand name for commercial beverages, a practice that public health advocates argue poses a significant risk to consumers, particularly children.

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The Heart of the Controversy: Medical Formula vs. Commercial Beverage

Oral Rehydration Solution, or ORS, is a specific, life-saving medical formulation recommended by the WHO to treat dehydration resulting from conditions like diarrhea and vomiting. Classified as a 'drug' under the Drugs and Cosmetics Act, 1940, its composition is scientifically standardized to replenish lost fluids and electrolytes effectively. The WHO-approved formula for a 21.80-gram sachet contains precise amounts of Sodium Chloride (2.6g), Potassium Chloride (1.5g), Sodium Citrate (2.9g), and Glucose Anhydrous (13.5g). Manufacturers of this medical-grade ORS must obtain a license from the State Drugs Control Authority and adhere to Good Manufacturing Practices (GMP).

The current legal dispute, however, centers on commercial beverages that use 'ORS' prominently in their branding, such as JNTL Consumer Health's 'ORSL'. These products, licensed by the FSSAI as food products, often contain high levels of sugar and do not follow the WHO's carefully balanced formula. Pediatricians have warned that consuming these beverages under the mistaken belief that they are medical ORS can be counterproductive and may even worsen dehydration and related symptoms.

A Timeline of Regulatory Back-and-Forth

The issue was first brought to the attention of regulatory bodies in 2021 by Dr. Sivaranjani Santhosh, a Hyderabad-based pediatrician who petitioned the Central Drugs Standard Control Organisation (CDSCO) to stop the practice. The CDSCO deferred to the FSSAI, which had licensed the products.

This led to a series of conflicting directives from the food safety regulator: 1. April 8, 2022: The FSSAI initially banned brands from using the term 'ORS' unless their products met WHO standards, deeming its use on juices and energy drinks as "false and misleading." 2. July 14, 2022: The FSSAI revised its stance, allowing the use of 'ORS' on labels provided a clear disclaimer was displayed: "The product is not an ORS formula as recommended by WHO." 3. October 14, 2025: In a significant reversal, the FSSAI withdrew all its previous directives. It issued a new order unequivocally instructing companies to cease using the term 'ORS' unless their formulations strictly complied with the WHO-recommended standards. This order also revoked the permission for using a disclaimer, making non-compliant manufacturers liable for punishment under the Food Safety and Standards Act, 2006.

Following this definitive ban, JNTL Consumer Health, a subsidiary of Johnson & Johnson, challenged the FSSAI's order in the Delhi High Court. The company secured an interim stay, permitting it to sell its existing stock, valued between ₹155 crore and ₹180 crore.

High Court's Impatience and the "Consent Order"

The case took a new turn during a recent hearing where the Court reviewed the progress made since it passed a "consent order." The order's objective was to allow the FSSAI to consider a representation made by JNTL and arrive at a decision. However, the Court expressed its profound frustration with the regulator's two-week delay.

“I would have restrained the manufacturers from manufacturing fresh batches had I known that the FSSAI would take two weeks to take a decision," the Court remarked sternly. It clarified the spirit and intent behind its earlier directive: "The consent order was passed to enable the FSSAI to take the requisite steps. It wasn’t to allow all these manufacturers to continue manufacturing these products. The idea was that the FSSAI would do the needful in two to three days.”

This judicial clarification is critical. It reframes the consent order not as a procedural delay tactic for the company, but as an instruction for expedited regulatory action. The Court’s statements signal that its patience is wearing thin and that it prioritizes public health concerns over procedural lethargy.

In response to the Court's admonishment, counsel for the FSSAI submitted that the authority would decide on the matter by the upcoming Friday. The Court put the regulator on notice, stating, “If you [FSSAI] are unable to do it, you move an application. I contemplate passing orders to restrain the manufacturers from manufacturing.”

Legal Implications and the Road Ahead

This case highlights several complex legal and regulatory intersections:

• Trademark vs. Public Health: It pits a company's right to use a brand name that incorporates a well-known acronym against the regulator's duty to prevent consumer deception and protect public health. The central question is whether a generic, medically significant term like ORS can be appropriated for commercial branding, especially when it could lead to harmful health outcomes.
  
  
• Judicial Oversight of Regulators: The Delhi High Court's active role demonstrates a robust system of judicial oversight. The Court is not merely reviewing the legality of the FSSAI's final order but is also scrutinizing the timeliness and efficiency of the regulatory process itself. Its threat to intervene directly with a manufacturing ban is a powerful assertion of its inherent powers to prevent public harm.
  
  
• Interpretation of Consent Orders: The Court's commentary provides an important lesson on the nature of consent orders. It clarifies that such orders, particularly in matters of public interest, are meant to be instruments of efficiency, not licenses for continued non-compliance pending a leisurely review.

For legal professionals in food law, intellectual property, and administrative law, this case is a crucial one to watch. The final FSSAI decision and any subsequent judicial review will set a significant precedent for how regulators must balance commercial interests with their primary mandate of consumer safety. The outcome will likely influence labeling regulations for a wide range of products that sit on the cusp between food and medicine, often referred to as 'nutraceuticals' or 'functional foods'.