The Regulatory Framework

Until 2016 there was no standard into which an “Energy Drink” fitted. Carbonated beverages could carry caffeine only up to the limit prescribed for them, and the drinks sold under that name contained a good deal more, so for years they sat outside the standards altogether. FSSAI dealt with this in 2016 by introducing a standard for "Caffeinated Beverages" under sub-regulation 2.10.6 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 (FPS Regulations). Products complying with this standard are licensed under FCS 14.1.4.1 and 14.1.4.2 of the Food Category System. The use of the descriptor “Caffeinated Beverages” rather than “Energy Drinks” was a terminological choice whose significance has now become apparent.

On 28 March 2024, the FSSAI issued an advisory to e-commerce food business operators (2024 Advisory) clarifying that the descriptor "Energy" drinks could be used for products licensed under FCS 14.1.4.1 and 14.1.4.2 and standardised under sub-regulation 2.10.6(2) of the FPS Regulations. However, the present Notices appear to proceed on a different understanding of the same regulatory framework. FSSAI has stated that it has not notified any standard for “Energy Drink”, that the Food Category System is not intended for product naming, and that claims such as “vitalises body and mind”, “enhancing focus”, “boost energy levels” and “aid in general weakness” are impermissible under the Food Safety and Standards Act, 2006 (FSS Act). The contradiction between the 2024 Advisory and the Notices gives rise to arguments grounded inter alia in legitimate expectation and promissory estoppel. Food business operators (FBOs) that relied on the 2024 Advisory in designing their labels may contend that FSSAI cannot reverse its position without following the legislative and regulatory procedures. In fact, the contradiction also undermines FSSAI's own assertion that the descriptor was never permissible as in such an event, the 2024 Advisory would itself have been ultra vires.

The statutory framework operates at three levels. Section 26(2)(ii) of the FSS Act prohibits an FBO from manufacturing, storing, selling or distributing any misbranded food, and Section 3(1)(zf) defines “misbranded food” to include food offered or promoted for sale with false, misleading or deceptive claims on its label or through advertisement. Section 23 of the FSS Act, in turn, requires packaged food to be labelled in the manner specified by regulations and stipulates that a label shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the food. The phrase “misleading in any particular” imports both an objective standard (capable of misleading) and a contextual inquiry (misleading in what particular). Section 24 separately restricts misleading advertisements, and these provisions together regulate the informational environment around packaged food. The Food Safety and Standards (Advertising and Claims) Regulations, 2018 (Claims Regulations) require every claim to be truthful, unambiguous and scientifically substantiated under Regulation 4, and Regulation 11 mandates prior approval of FSSAI for reduction of disease risk claims other than those defined in the regulations and for which criteria are laid down therein.

The Food Safety and Standards (Labelling and Display) Regulations, 2020 (Labelling Regulations) impose a distinct obligation: Regulation 5(1) requires every package to carry on its front of pack the name of the food, which must indicate the true nature of the food. Where the regulations specify an essential composition for a food that establishes its identity, the name provided therein must be used, and otherwise a common or usual name or an accompanying description of the true nature of the food. Regulation 4(3) further stipulates that a pre-packaged food shall not be described or presented on its label in a manner that is false, misleading or deceptive or likely to create an erroneous impression regarding its character. This creates a dual test: the name must accurately describe the product, and it must not suggest qualities the product does not possess. Contravention of the misbranding provisions attracts a penalty of up to INR 3,00,000 under Section 52, while a misleading advertisement attracts a penalty of up to INR 10,00,000 under Section 53. Section 38 authorises Food Safety Officers to seize any article of food appearing to contravene the Act or the regulations made thereunder, and adverse licensing consequences under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 may follow at the State level.

Legal Questions: Balancing Legislative, Enforcement and Marketing Interests

The FSS Act draws a line between making standards and enforcing them. Standards are framed as regulations under Section 92, after prior publication and consideration of objections, and are laid before Parliament under Section 93. The enforcement provisions then operate on the standards so made. The Bombay High Court considered this boundary in Vital Nutraceuticals Private Limited v Union of India [2014 SCC OnLine Bom 195]. The Hon'ble Court struck down the FSSAI's product approval advisories, stating that substantive requirements cannot be imposed without following the procedure in Sections 92 and 93 of the FSS Act. The Hon'ble Supreme Court, while dismissing the Special Leave Petition filed by FSSAI against the judgment, affirmed the Bombay High Court's view.=

When the Notices are challenged, the central issue is which side of that line the present exercise falls on. It may be contested that FSSAI is creating a new product naming restriction through executive action rather than the regulation-making procedure. In this regard, FSSAI would raise a counterargument that if the descriptor renders a label misleading within the meaning of Section 3(1)(zf) of the FSS Act, action against it is enforcement of an existing prohibition, not the creation of a new one. Even if such a counterargument were to be accepted, whether a descriptor is misleading or not is a mixed question of fact and law, and FSSAI has not published the evidentiary basis for its determination. The Bombay High Court's judgment in M/s Nestle India Limited v Food Safety and Standards Authority of India [2015 SCC OnLine Bom 4713] points the same way. The order banning Maggi noodles was set aside largely for want of fair procedure.

Pertinently, commercial speech has the protection of Article 19(1)(a) of the Constitution of India, and what the statute forbids is speech that misleads. The argument comes down to a question of fact: does the phrase “Energy Drink”, on a can that already states its caffeine content and carries the warnings the standard requires, tell the consumer something untrue? The phrase is used in much of the world, usually next to a mandatory high caffeine warning, and the regulatory treatment abroad is far from uniform. It does not appear that any Indian court has yet had to decide whether a descriptor in common commercial use, and tolerated by FSSAI for years, can be called misleading in itself.

The Notices also take objection to particular claims. “Vitalises body and mind” and “aid in general weakness” are claims about what the drink does for the body, and a claim of that kind has to be substantiated scientifically under the Claims Regulations, with the burden of substantiation resting on the FBO. “Boosts energy levels” is the closer case, because the stimulant effect of caffeine is well documented, but the Claims Regulations make no allowance for familiar ingredients and the substantiation is required all the same. What can fairly be asked is that these claims be assessed on the basis of scientific substantiation, rather than by a notice that treats the conclusion as already reached. A separate complication arises for brands incorporating “Energy” in their registered trademarks under the Trade Marks Act, 1999.

The Road Ahead

The Notices are part of a larger pattern. In June 2024 FSSAI made FBOs drop "100 per cent" claims from reconstituted fruit juices, and in August 2026 it barred certain Dabur products carrying similar claims. FSSAI is now concerned with what a packaged food calls itself, and not only with what is in it.

It is clear that none of the questions raised by the present Notices has a settled answer. Whether the 2024 Advisory gave the industry a legitimate expectation, and whether "Energy Drink" is misleading in itself, are the two questions that matter most. Whether a licence describing the product as an energy drink carries a vested right to the name, how far a court will review FSSAI's choice of enforcement tool, and whether an improvement notice under Section 32 had to come first, remain open as well. Each point is arguable and will have to be settled in court. Recently, the Delhi High Court has set aside an order passed by the FSSAI directing a popular beverage brand to discontinue the use of the descriptor 'Energy Drink' on its range of caffeinated beverages for failure to adopt principles of natural justice.

What the Notices really test is how far FSSAI's authority runs: whether an enforcement notice can do what no regulation has done, and whether a descriptor that FSSAI itself permitted in 2024 can be taken away by executive action two years later. The answers will matter well beyond energy drinks, because they will settle the terms on which FSSAI deals with the food industry as a whole.

The article has been authored by Jeevan Ballav Panda (Partner), Sankalp Udgata (Senior Associate) & Saurabh Samraat (Associate) at Khaitan & Co. Views expressed are personal.