FSSAI Bans “ORS” in Food Branding: Health Care Law Update & Healthcare Legal Consultant India Guide (2025)

Introduction

On 15 October 2025, the Food Safety and Standards Authority of India (FSSAI), issued an Order withdrawing all previous permissions for the use of the term “ORS” with any brand names [1]. Earlier orders dated 14 July 2022 [2] and 2 February 2024 [3] had permitted use of “ORS” as part of a trademark or brand name subject to the declaration that “The product is NOT an ORS formula as recommended by WHO.” This regulatory update comes against the backdrop of diarrhoea which remains a significant public health challenge. Diarrhoea ranks as the third leading cause of mortality among children in India, accounting for approximately 13% of all deaths in children under five years of age each year [4]. The primary threat from diarrhoeal disease is dehydration, which can be treated simply, effectively, and inexpensively with an Oral Rehydration Salts (ORS) solution. The World Health Organisation (WHO)-recommended ORS formula is a specific, life-saving composition of salts and glucose designed for rapid rehydration. However, a critical public health issue emerged as numerous commercial products, such as ORSL, Gatorade, Enerzal, and Tata Gluco Plus, entered the market. While sold as electrolyte drinks, these beverages did not conform to the precise therapeutic formulation recommended by the WHO. The use of names and branding that closely resembled “ORS” led to widespread consumer confusion, with many purchasing these flavoured beverages under the false impression that they were suitable for managing clinical dehydration. This substitution posed a serious health threat, as patients suffering from severe diarrhoea were not receiving the required therapeutic intervention.

Paediatrician’s Persistence: The Eight Year Long Battle to the Latest FSSAI Order

In response to the deceptive marketing, Dr. Sivaranjani Santosh, a Hyderabad-based paediatrician, took legal action after repeatedly witnessing parents administer these drinks to sick children in place of medically approved ORS. In 2022, she filed a Public Interest Litigation (PIL) in the Telangana High Court challenging companies that marketed fruit-based or flavoured drinks as ORS despite not meeting WHO or Indian Pharmacopoeia standards [5]. Her petition underscored the potential dangers of such misrepresentation and urged regulatory authorities to act against misleading labelling practices. Cases like these highlight why having a reliable healthcare legal consultant india becomes essential for navigating the intersection of public health and regulatory law. The use of the term “ORS” in brand names and food labels posed serious risks to patients. Because of these misleading labels, parents had been giving such drinks to infants and children, leading to health complications and, in some cases, even fatalities, as highlighted in the PIL.

What is ORS?

ORS is a medically formulated solution essential for treating dehydration resulting from conditions like severe diarrhoea, heat stroke, or other illnesses that cause significant fluid loss. It is a specific and carefully balanced mixture of salt and sugar that, when dissolved in clean water, effectively replenishes lost fluids and electrolytes in the body, making it a critical tool in managing childhood diarrhoea. Under Indian laws, authentic ORS is defined as a drug. Chapter IV of the Drugs and Cosmetics Act states that all drugs shall be of standard of quality meeting IP/bp/usp mentioned in Schedule 1 of the Act [6]. Its composition is specified in point no. 27 under Schedule K of the Drugs and Cosmetics Rules, 1945 [7]. Schedule K is a provision under Rule 123 [8] that lists certain drugs exempted from specific licenses (like a sale license) to ensure their wider availability to the public. The official formula for ORS to be dissolved in one litre of water (as defined in the notification G.S.R. 57(E) dated 07 February 1995 [9]) is as follows:

Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:—

• Sodium—50 to 90 millimoles
• Total osmolarity—240 to 290 milli osmoles
• Dextrose: Sodium molar ratio—Not less than 1:1 and not more than 3:1.

Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain:—

• Sodium—50 to 90 millimoles.
• Total osmolarity—Not more than 290 milli osmoles.
• Precooked rice—Equivalent to not less than 50 gms and not more than 80 gms as total replacement of Dextrose.

Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labelled with the indication for “Adult Choleratic Diarrhoea only”. Patent and Proprietary Oral Rehydration Salts shall not contain mono or Polysaccharides or saccharin sweetening agent. WHO guidelines on the manufacture of the new ORS can be accessed here [10]. Cosmetics Rules, is regulated by the Central Drugs Standard Control Organisation (CDSCO).

Why the FSSAI Stepped In to Regulate ORS?

While ORS is primarily a therapeutic formulation regulated under the Drugs and Cosmetics Act, 1940, the Food Safety and Standards Authority of India (FSSAI) is empowered to intervene when food or beverage manufacturers use the term “ORS” in their product names, labelling, or advertisements. This authority flows from Section 16(5) [11] and Section 22 [12] read with Section 3(1)(j) [13] of the Food Safety and Standards Act, 2006 (FSSA), which entrusts FSSAI with the responsibility to regulate the manufacture, storage, distribution, sale, and import of food to ensure safe and wholesome products for human consumption. Understanding these regulatory nuances is where pharmaceutical company legal advisory india services play a pivotal role in helping businesses remain compliant. In recent years, several manufacturers of flavoured beverages and electrolyte drinks began branding their products with the term “ORS,” creating a misleading impression that such products possessed therapeutic rehydration properties comparable to pharmaceutical-grade ORS. Since these products were marketed and sold as food items rather than licensed drugs, they fell within FSSAI’s regulatory jurisdiction. By invoking its powers under the misbranding and misleading claims provisions (Sections 23 [14] and 24 [15]) of the FSSA, FSSAI sought to prevent consumer deception and protect public health.

FSSAI Orders on the Use of the Term “ORS”

Order dated 08 April 2022 [16]

The FSSAI Order dated 08 April 2022 was issued under Section 16(5) of the Food Safety and Standards Act, 2006 [7] to curb misleading advertisements and marketing of food products falsely labelled as “ORS” or similar terms. It cites Regulation 2.2.1(3) of the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 [17] and Regulation 4(3) of the Labelling and Display Regulations, 2020 [18], which prohibit false or deceptive labelling likely to create an erroneous impression about a product. This directive clarified that ORS is a drug formulation governed by the Drugs and Cosmetics Rules, 1945 and prescribed by the Drugs Controller General of India (DCGI) for treating dehydration due to diarrhoea. However, some food business operators (FBOs) licensed under FSSAI were marketing fruit-based or non-carbonated beverages using misleading terms like “ORSL,” “ORSL Rehydrate,” or “Electro Plus ORS.” FSSAI declared that such products amount to “misbranded food” under Section 3 [13] and are punishable under Sections 52 [19] and 53 [20] of the FSSA.

Order dated 14 July 2022 [2]

In this Order, the FSSAI, in response to representations and court direction (in WP(C) No. 9051/2021), reviewed its earlier prohibition of using “ORS” or similar terms in food product labels. It noted that certain food business operators (FBOs) hold valid trademarks containing “ORS.” Thus, the order allowed these FBOs to continue using their trademarked names temporarily, pending a decision by the Controller General of Patents, Designs & Trademarks (CGPDTM). However, such continuity is conditional: if the CGPDTM rules against the trademark, the FBO must cease production under that name, recall existing products, and not use pre-printed packaging with “ORS.” For other FBOs without prior trademarks, the use of “ORS” in names must be discontinued, and they were given six months to exhaust existing stock and packaging. Meanwhile, all permitted products must carry a prominent declaration on the front label stating that “The product is NOT an ORS formula as recommended by WHO,” or equivalent phrasing, to prevent consumer confusion.

Order dated 02 February, 2024 [3]

This FSSAI Order, issued after the order dated 14 July 2022, clarifies the regulatory position regarding the use of the term “ORS” in brand names by Food Business Operators (FBOs). Initially, FSSAI had allowed FBOs with valid registered trademarks containing “ORS” to continue using them until the CGPDTM gave its final decision. The CGPDTM later clarified that, under Section 17 of the Trade Marks Act, 1999 [21], the use of the word “ORS” along with a prefix or suffix may be permitted as part of the trademark “as a whole.” In light of this clarification, FSSAI permitted such FBOs to continue manufacturing products using “ORS” with prefixes or suffixes, subject to strict labelling and disclaimer requirements. These include a prominent front-of-pack declaration stating “The product is NOT an ORS formula as recommended by WHO,” with minimum font sizes prescribed based on the packaging area. Additionally, FBOs must comply with Regulation 4(7) of the FSS (Advertising and Claims) Regulations, 2018 [22], by displaying another disclaimer that the name is a brand or trademark and does not represent the product’s true nature. Compliance with these requirements became mandatory from 1 April 2024, ensuring consumers are not misled by brand names resembling therapeutic ORS formulations. Businesses seeking to understand such compliance timelines often consult with the best tech law firms in Delhi that specialise in food, pharma, and health care law matters.

Order dated 15 October 2025 [1]

The FSSAI clarification dated 15 October 2025 was issued to reinforce the regulatory position on the use of the term “ORS” (Oral Rehydration Solution) in food product names and labelling. This clarification explicitly withdraws all previous permissions that had allowed Food Business Operators (FBOs) to use “ORS” or similar terms with prefixes or suffixes under certain conditions, such as trademark ownership or the use of disclaimers. The order states that no food or beverage product licensed under FSSAI may now carry the word “ORS” in its name, label, or advertisement unless it strictly conforms to the WHO-recommended ORS formulation, which falls under the jurisdiction of the Drugs and Cosmetics Act, 1940. Any such usage will henceforth be treated as misbranding or misleading representation under the Food Safety and Standards Act, 2006, inviting regulatory and penal action.

Regulatory and Legal Framework

Food Safety and Standards Act, 2006

Section 23: Packaging and Labelling of Foods [14] – This section prohibits the sale of any packaged food that is not labelled in the manner specified by regulations. Crucially, it mandates that labels must not contain any statement, claim, or design that is false or misleading about the food product, its nutritive value, or if it implies medicinal or therapeutic benefits. Using the medical term “ORS” on a beverage is considered a misleading claim that implies therapeutic qualities. Section 24: Restrictions of Advertisement and Prohibition as to Unfair Trade Practices [15] – This provision forbids any advertisement for a food product that is misleading or deceptive. It also prohibits unfair trade practices, such as falsely representing the quality or standard of a food item or making a misleading representation about its usefulness. Branding a beverage as “ORS” is seen as an unfair trade practice that deceives consumers about its purpose and efficacy.

Food Safety and Standards (Labelling and Display) Regulations, 2020

Sub-regulation 4(3): General Requirements [18] – This regulation states directly that pre-packaged food must not be described or presented on its label in a way that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect”. The use of “ORS” on a simple beverage creates a false and erroneous impression that it is a medical-grade rehydration solution. Sub-regulation 5(1): The Name of Food [23] – This rule requires that the name of the food, displayed on the front of the pack, must indicate the “true nature of the food”. An electrolyte drink’s true nature is that of a beverage, not a medically formulated Oral Rehydration Salt. Using a brand name that includes “ORS” fails to represent the product’s true character and is therefore a violation.

Food Safety and Standards (Advertising & Claims) Regulations, 2018

Sub-regulation 4(1) and 4(13): General Principles [22] – These regulations set the foundational rules for all claims made about food products. Sub-regulation 4(1) demands that all claims must be “truthful, unambiguous, meaningful, not misleading” and easy for consumers to understand. Sub-regulation 4(13) explicitly states, “No advertisement shall be made for food products which is deceptive to the consumers”. Using “ORS” on a beverage violates both principles by being inherently misleading and deceptive.

Penalties Under the FSS Act, 2006

Section 52: Penalty for Misbranded Food [19] – This section outlines the penalty for anyone who manufactures, stores, sells, or imports misbranded food. A product is considered misbranded if its label is false or misleading. The penalty for such a violation can extend up to three lakh rupees. The Adjudicating Officer may also order corrective action or the destruction of the product. Section 53: Penalty for Misleading Advertisement [20] – This section applies to any person who publishes or is party to a misleading advertisement that falsely describes a food product or is likely to mislead consumers as to its nature, substance, or quality. This is a more severe offense, with a penalty that can extend up to ten lakh rupees.

Consumer Protection Rationale behind FSSAI’s 2025 Order

The latest FSSAI Order dated 15 October 2025 prohibiting the use of the term “ORS” in the branding, labelling or advertisement of food and beverage products is rooted in the broader consumer protection objective of preventing misleading representations and unfair trade practices in the marketplace. From a health care law standpoint, this order represents a landmark intervention that aligns food regulation with constitutional and statutory consumer rights. Under Section 2(9) of the Consumer Protection Act, 2019 (CPA) [24], the term “consumer rights” includes the right to be protected against marketing of goods and services which are hazardous to life and property and the right to be informed about the quality, quantity, potency, purity, standard and price of goods. By allowing non-therapeutic beverages to use the term “ORS,” consumers could be misled into believing that these products possess clinical rehydration properties, potentially delaying proper medical treatment. Hence, restricting such use directly upholds the right to information and protection from deceptive marketing. Further, Section 2(28) of the CPA [24] defines an “unfair trade practice” to include false or misleading representation of the standard, quality or grade of goods, while Section 10 empowers the Central Consumer Protection Authority (CCPA) to issue directions or recall orders against such practices. The CCPA (Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements) Guidelines, 2022 [25] also prohibit advertisements that mislead consumers regarding the nature, substance or efficacy of a product or exploit their lack of knowledge. The Supreme Court, in Centre for Public Interest Litigation v. Union of India [26], recognised that the right to safe and wholesome food is an integral component of the right to life under Article 21 of the Constitution of India [27]. It was held that:

• “We may emphasis that any food article which is hazardous or injurious to public health is a potential danger to the fundamental right to life guaranteed under Article 21 of the Constitution of India. A paramount duty is cast on the States and its authorities to achieve an appropriate level of protection to human life and health which is a fundamental right guaranteed to the citizens under Article 21 read with Article 47 of the Constitution of India.”

By prohibiting the misleading use of “ORS” in food products, FSSAI thus upholds both the statutory rights of consumers under the Consumer Protection Act and the fundamental right to safe food guaranteed by Article 21. The Order ensures that consumers are not deceived by deceptive marketing practices, thereby strengthening the framework of truthful labelling, informed choice, and health protection, the very pillars of India’s consumer jurisprudence.

Implications for Stakeholders

For Industry

The directive presents immediate and substantial challenges for Food Business Operators (FBOs) whose products have utilized the “ORS” acronym. The implications of this Order are multifaceted, encompassing operational, legal, and financial dimensions. Engaging a best tech law firm with expertise in food safety and pharmaceutical regulations can help companies assess their exposure and restructure their branding strategies in line with the new directives. The Order also carries significant legal and regulatory implications. FBOs who continue to use the term “ORS” risk being classified as offering “misbranded” or “misleading” products under the Food Safety and Standards Act, 2006. Non-compliance exposes companies to penalties under Sections 52 [19] and 53 [20] of the Act, which can include fines of up to ten lakh rupees, product seizures, and potential prosecution. With the immediate withdrawal of previous permissions granted in 2022 [2] and 2024 [3], any ambiguity regarding compliance has been removed, making strict adherence to the directive essential to avoid legal consequences. Following the issuance of the Order, the industry now awaits further directives from the regulatory authority, which are expected to detail the specific timelines for compliance and the procedures for withdrawing non-compliant products from the market.

For Consumers

From a consumer rights perspective, this move reinforces the principle that every individual has a right to safe and accurately labelled food and health products. Under the Consumer Protection Act, 2019, consumers are entitled to protection against goods that are hazardous to life or health and against unfair trade practices. The Order aligns with Section 2(36) and Section 2(47) of the Act [24], which define “unfair trade practices” and “misleading advertisements” respectively, by ensuring that products marketed as ORS truly meet established standards and do not create false impressions about their efficacy. Furthermore, the Order addresses broader public health concerns by standardizing the quality of ORS available in the market. Access to a reliable and effective rehydration solution is especially important for vulnerable populations, such as children and the elderly. Consumers can now be reasonably assured that any product labelled as ORS has been vetted for safety and compliance, reducing the risk of ineffective treatment during episodes of dehydration. In essence, this regulatory measure enhances consumer trust, promotes informed decision-making, and reinforces the fundamental right to safe food and health products in India.

For Regulators

From an operational perspective, the Order necessitates the development and implementation of clear guidelines, inspection protocols, and verification mechanisms. Regulatory authorities must ensure that only formulations conforming to the prescribed compositional standards are approved for marketing as ORS. The authorities will have to be swift regarding the implementation protocol of the Order, and a close watch will be required to ensure compliance. This may involve increased sampling, laboratory testing, and monitoring of advertisements and packaging to detect and prevent violations. The move also strengthens the regulatory enforcement framework by providing a legal basis to initiate penalties or product recalls for non-compliant entities, thereby reinforcing the deterrent effect of the law. Regulatory bodies may also benefit from structured collaboration with pharmaceutical company legal advisory india professionals who can bridge enforcement gaps across drug and food regulatory domains. Moreover, the Order aligns regulatory oversight with consumer protection objectives under the Food Safety and Standards Act, 2006 and relevant provisions of the Consumer Protection Act, 2019, particularly regarding misleading claims and unfair trade practices. By defining clear boundaries for the use of the term “ORS,” regulators can ensure consistency in enforcement, reduce ambiguity in compliance requirements, and enhance public confidence in the effectiveness of regulatory measures. In essence, this step strengthens FSSAI’s capacity to uphold food safety standards, mitigate risks to public health, and maintain the integrity of the Indian food regulatory ecosystem.

Conclusion

In conclusion, the FSSAI’s 15 October 2025 Order marks a decisive step towards safeguarding public health and ensuring consumer protection in India. By prohibiting the use of the term “ORS” in food and beverage branding, labelling, and advertisements, the regulatory authority has closed a loophole that allowed non-therapeutic products to be misleadingly marketed as medical-grade rehydration solutions. The directive not only protects consumers from potentially hazardous or ineffective products but also reinforces the broader principles of truthful labelling, informed choice, and the right to safe and wholesome food under Article 21 of the Constitution and the Consumer Protection Act, 2019. For organisations navigating such complex regulatory landscapes, guidance from a healthcare legal consultant india or the best tech law firms in delhi well-versed in health care law remains indispensable. Overall, this regulatory intervention underscores the importance of aligning food industry practices with public health imperatives, promoting accountability among manufacturers, and strengthening the legal and institutional framework to prevent misleading marketing practices. It reaffirms the commitment of FSSAI and other authorities to uphold the health, safety, and rights of consumers across the country.

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