FSSAI Files Three Adjudication Cases Against Nestlé India Over Infant Formula Claims and Biotin Content

Open in the app — quiz, notes, Mistake Vault

The news

The Food Safety and Standards Authority of India said on Friday that it has initiated legal action against Nestlé India Ltd. for alleged non-compliance with food safety norms in three infant nutrition products, PTI reported in The Hindu. The Economic Times reported that the regulator filed three separate cases for adjudication against the company in connection with NAN Excella Pro Stage 1 and Lactogen Pro 1, and a laboratory finding relating to biotin content in a follow-up formula. FSSAI said it examined the infant nutrition products and the promotional material available on e-commerce platforms and found that claims relating to “5 HMOs”, a blend of five human milk oligosaccharides, and to whey protein being easy to digest, were not appropriate. The Hindu's account specifies that in NAN Excella Pro Stage 1 the regulator flagged claims relating to “5HMOs” and “Whey Protein”, and in Lactogen Pro 1 a claim describing “Whey Protein” as easy to digest. The regulator said it sought clarifications from Nestlé India. Both products were found to be in contravention of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional claims or material intended to increase the saleability of infant foods. Separately, a sample of a follow-up formula manufactured by the company was found to be substandard with respect to its biotin content during laboratory analysis; the sample was sent for re-analysis and the referral laboratory also found that it did not conform to the prescribed requirement of the water-soluble B vitamin under the same 2020 Regulations. The regulator also cited Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which prohibits certain advertising and promotion of infant milk substitutes and infant foods. On social media FSSAI said, “Legal action initiated against Nestlé India Ltd over several non-compliances pertaining to the FSS Act.” A Nestlé India spokesperson said the company adheres to all regulations including all rules and label declarations as per applicable laws, and that “our products are fully compliant with all applicable regulations. The said products (i.e., Nan Excella Pro and Lactogen Pro) and their labels were approved by the expert committee of FSSAI.” The company said it had again submitted a detailed response to the authorities regarding statements appearing on the label, which it described as factual in nature and supported by scientific literature.

The chain in one line: Infant formula sells increasingly through e-commerce → marketing claims migrate from the tin's label, which an FSSAI expert committee clears in advance, to product pages and promotional material that nobody clears in advance → FSSAI examines those listings for NAN Excella Pro Stage 1 and Lactogen Pro 1 → finds the “5 HMOs” and easy-to-digest whey protein claims outside Regulation 4(2) of the 2020 infant nutrition regulations → three cases filed for adjudication, with a separate substandard-biotin finding in a follow-up formula confirmed on referral analysis

Static syllabus linkage

One statute replaced eight, and it created the regulator that is acting here. The Food Safety and Standards Act, 2006 consolidated the scattered body of Indian food law, subsuming the Prevention of Food Adulteration Act, 1954 along with the control orders on fruit products, meat food products, vegetable oil products, edible oils packaging, solvent-extracted oils and milk and milk products. It established the Food Safety and Standards Authority of India as a statutory body under the Ministry of Health and Family Welfare, consisting of a Chairperson and twenty-two members, with a Chief Executive Officer as its administrative head. FSSAI's core functions are to lay down science-based standards, regulate manufacture, storage, distribution, sale and import of food, and accredit laboratories. Enforcement on the ground is carried out by State Food Safety Commissioners, Designated Officers at district level and Food Safety Officers, which is why the Act is a Centre-State machine rather than a purely central one.
The Act separates civil adjudication from criminal prosecution, and this case is on the civil side. Offences involving substandard or misbranded food and misleading advertisement are dealt with by penalties imposed by an adjudicating officer not below the rank of an Additional District Magistrate, appointed by the State government. A penalty for substandard food may extend to ₹5 lakh under Section 51, and for a misleading advertisement to ₹10 lakh under Section 53. An appeal against the adjudicating officer's order lies to the Food Safety Appellate Tribunal. Genuinely unsafe food, by contrast, attracts prosecution before a court with imprisonment graduated by the injury caused, which is why the phrase “cases filed for adjudication” in the reports signals the civil track and not a criminal complaint.
Infant food carries a second, stricter statute administered by a different ministry. The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, amended in 2003, prohibits the advertisement and promotion of infant milk substitutes, feeding bottles and infant foods, bans the supply of free samples and of donations to hospitals, and requires labels to state that mother's milk is best for the baby. The 2003 amendment extended the prohibition to foods marketed for children up to two years of age. The Act is administered by the Ministry of Women and Child Development, separately from the FSS Act's health ministry lineage, and it is among the strictest national enactments of the WHO International Code of Marketing of Breast-milk Substitutes adopted by the World Health Assembly in 1981. Its logic is that in this one market the remedy is prohibition of promotion rather than regulation of promotion.
The constitutional and international scaffolding behind food standards. Article 47 of the Constitution places on the State the primary duty of raising the level of nutrition and the standard of living and improving public health, and it is the stated Directive Principle behind the FSS Act's preamble. Internationally, the Codex Alimentarius Commission, established in 1963 as a joint body of the Food and Agriculture Organization and the World Health Organization, sets reference standards for food including compositional requirements for infant formula, and FSSAI harmonises Indian standards with Codex where it can. The WHO recommends exclusive breastfeeding for the first six months of life, and the National Family Health Survey has placed the Indian figure at roughly two-thirds of infants under six months. That gap is the commercial space in which infant formula marketing operates, and the reason the law treats it differently from other food.

Why UPSC loves this

Regulatory bodies are a fixed Prelims target and FSSAI is the most examinable of them. The paper regularly asks whether a body is statutory, constitutional or executive, which ministry it reports to, and what its parent Act is. FSSAI answers all three cleanly — statutory, FSS Act 2006, Ministry of Health and Family Welfare — and its penalty and adjudication architecture is exactly the kind of detail that separates a prepared candidate from a well-read one.
The syllabus link runs through both GS2 and GS3. GS2 carries 'issues relating to development and management of social sector relating to health' and 'statutory, regulatory and various quasi-judicial bodies'; GS3 carries 'food processing and related industries in India'. A case about infant nutrition standards and their enforcement sits at the intersection, and can be used in an answer on regulatory capacity as readily as one on child nutrition.
The examinable tension is approval versus supervision. The company's defence is that its labels were cleared by an FSSAI expert committee; the regulator's charge concerns promotional material on e-commerce platforms. UPSC rewards candidates who notice that both statements can be true simultaneously, because they describe different objects. That gap between ex-ante approval and continuing supervision is a general theme across Indian regulation, from drugs to financial products.

Prelims nuggets

The Food Safety and Standards Authority of India is a statutory body established under the Food Safety and Standards Act, 2006 and functions under the Ministry of Health and Family Welfare; it consists of a Chairperson and twenty-two members, with a Chief Executive Officer as its administrative head.
The FSS Act, 2006 consolidated earlier food laws including the Prevention of Food Adulteration Act, 1954 and the control orders relating to milk and milk products, meat food products, vegetable oil products and fruit products.
Under the FSS Act, the penalty for substandard food may extend to ₹5 lakh under Section 51 and for a misleading advertisement to ₹10 lakh under Section 53; such penalties are imposed by an adjudicating officer not below the rank of Additional District Magistrate.
An appeal against an order of the adjudicating officer under the FSS Act lies to the Food Safety Appellate Tribunal.
The Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 govern infant formula and follow-up formula; Regulation 4(2) restricts promotional claims or material intended to increase the saleability of infant foods.
Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 prohibits the advertisement and promotion of infant milk substitutes, feeding bottles and infant foods; the Act is administered by the Ministry of Women and Child Development.
The WHO International Code of Marketing of Breast-milk Substitutes was adopted by the World Health Assembly in 1981, and the Codex Alimentarius Commission, established in 1963 as a joint FAO-WHO body, frames international food standards including those for infant formula.

Analysis

The company's defence and the regulator's charge are not about the same document. Nestlé says the labels of NAN Excella Pro and Lactogen Pro were approved by an FSSAI expert committee. FSSAI says it examined the products and the promotional material available on e-commerce platforms. Both can be accurate, because label approval is an ex-ante, product-specific clearance of a fixed artefact, while a product listing is variable, unreviewed and rewritten at will. The finding worth carrying out of this story is therefore structural rather than about one firm: India's food regulation clears the tin and then has no continuing eye on the page that sells it.
Infant nutrition is the one market where more information is not the remedy. The standard regulatory answer to a doubtful claim is disclosure — require the qualifier, print the evidence, let the buyer choose. That answer fails here for three compounding reasons. The purchaser is a parent making a decision under anxiety and time pressure, the consumer of the product cannot report an effect, and a claim like “5 HMOs” carries the form of scientific precision without offering any comparative benchmark against which a layperson could evaluate it. This is precisely why the IMS Act, 1992 chose prohibition of promotion over regulation of promotion, and why a policy answer that recommends 'better labelling' here has misread the market.
The biotin finding is legally the stronger case and analytically the weaker one. A laboratory result on micronutrient content, confirmed by a referral laboratory on re-analysis, is objective, documented and difficult to contest, and it is the count most likely to survive adjudication. But a shortfall of a water-soluble vitamin in a sampled batch is a manufacturing and quality-control failure, remedied by plant audit, batch traceability and process correction. The claims issue is a market-design failure, remedied by supervision of digital marketing. Treating them as a single story about one company's conduct obscures that the two defects have entirely different fixes, and an examiner will reward the candidate who separates them.
Two statutes and two ministries govern one tin, with predictable consequences. The FSS Act and its 2020 infant nutrition regulations run through the Ministry of Health and Family Welfare; the IMS Act, 1992 runs through the Ministry of Women and Child Development. Their prohibitions on promotion overlap, which is why a single enforcement action cites both. Overlapping jurisdiction generally produces either duplicated proceedings or, more often, each authority assuming the other is acting. The counter-view deserves recording: the IMS Act's severity was a deliberate legislative choice made in response to a global controversy over breast-milk substitute marketing, and folding it into a general food statute would almost certainly dilute it. The fix is coordination, not consolidation.
Enforcement by announcement is a real instrument with a real due-process cost. FSSAI publicised the action on social media while the matter is still at the stage of cases filed for adjudication. In a reputation-sensitive category this is far faster and far more powerful than any penalty the statute permits, and a regulator with limited inspection capacity would be foolish not to use it. The cost is that it collapses the distinction between an allegation and a finding, against a party that has a stated defence on record and a right of appeal to the Food Safety Appellate Tribunal. An honest answer accepts the deterrent logic and still registers that publicity should ordinarily follow adjudication rather than substitute for it.
The statutory penalties are too small to be the operative deterrent. A ceiling of ₹5 lakh for substandard food and ₹10 lakh for a misleading advertisement was set in 2006 and has not been indexed; against the marketing budget of a large multinational it is a rounding error. The behaviour-changing consequences in practice are recall, retailer delisting and reputational damage — which is another way of saying that the formal legal instrument has been substituted by an informal one. By contrast the Consumer Protection Act, 2019 gives the Central Consumer Protection Authority substantially larger penalties for misleading advertisements and the power to bar endorsers, which is the more credible model. The argument for raising FSS Act penalties is not punitiveness; it is that a regulator forced to rely on publicity because its statute is toothless will keep creating the due-process problem described above.

Possible Mains question

Regulatory approval of a product's label is not the same as regulatory control of its marketing. Discuss this proposition with reference to India's legal framework for infant nutrition products, and examine whether India's food safety enforcement architecture is adequate for a market in which promotion has shifted to digital platforms. (15 marks, 250 words)

Model approach

Introduction. Begin with the architecture rather than the incident. State in two sentences that infant nutrition in India is governed simultaneously by the FSS Act, 2006 with its Foods for Infant Nutrition Regulations, 2020 under the health ministry, and by the IMS Act, 1992 under the women and child development ministry, and that the second prohibits promotion outright. The reader must know there are two statutes before the argument about approval and supervision can land.
Body — set out the gap precisely. Explain that an expert committee clears a label, which is fixed and product-specific, whereas a marketplace listing and its promotional copy are variable, unreviewed and easily altered. Use the fact that Regulation 4(2) restricts promotional claims or material intended to increase saleability, and note that enforcement on digital material is necessarily reactive because nothing pre-clears it. This is the analytical core of the answer.
Body — explain why this market is treated differently from other food. Argue from information asymmetry: the buyer is a parent under pressure, the consumer is an infant who cannot report an effect, and scientific-sounding compositional claims have no lay benchmark. Connect this to Article 47 and to the WHO International Code of 1981, and explain that prohibition of promotion, rather than disclosure, is the deliberate regulatory choice that follows.
Body — assess enforcement capacity honestly, including the counter-argument. Note that penalties of ₹5 lakh and ₹10 lakh, fixed in 2006, are not a deterrent at corporate scale, that enforcement rests on State Food Safety Officers and Designated Officers with limited laboratory capacity, and that regulators therefore substitute publicity for penalty. Concede the legitimate counter-view that publicity is fast and effective, and then record the due-process cost of announcing before adjudication concludes.
Conclusion. Close with two specific, implementable proposals rather than a call for awareness: a continuing obligation on e-commerce platforms to carry only approved claim text for products in the infant nutrition category, and indexation of FSS Act penalties so that the formal instrument, rather than reputational damage, does the deterring. Both are concrete, and both follow from the argument you have made.

Administrator's brainstorm

You are the Designated Officer in a district and receive a complaint that a shop is displaying discount posters for infant formula. The shopkeeper says the manufacturer supplied the posters and that he has no idea any law prohibits them. What do you do?

Take the posters off the wall first, because the display continues to operate while any inquiry proceeds, and a prohibition on promotion that is enforced slowly is not enforced at all. Then separate the two parties in your own mind: the retailer's ignorance is entirely plausible and a written warning with an explanation of the IMS Act is the proportionate response to him, while the manufacturer who printed and distributed the material is the party against whom the case should actually be built. Seize the material, record where it came from, and obtain a statement about the supplying distributor before anyone has time to reconsider. Then do the thing that matters more than this one shop — send a circular to the district's chemists and retailers setting out exactly what may and may not be displayed, because most of this conduct is genuine ignorance and a circular prevents a hundred cases you would otherwise have to file.

A referral laboratory confirms that a batch of a follow-up formula sold in your district is below the prescribed micronutrient requirement. The company has approached you saying the deviation is marginal and within analytical tolerance, and asks you to defer action. What is your position?

The standard is a legal requirement and not a target, and a referral analysis exists precisely to settle the question of analytical variation, so once it has confirmed the original finding the argument about tolerance has already been heard and answered. Say that plainly and proceed to the adjudicating officer. At the same time, be exact about proportionality: this is a substandard-food matter on the civil track, not unsafe food, so the remedy is penalty and corrective action rather than prosecution, and you should say so to the company as clearly as you say the first part. Ask for the batch distribution record and require withdrawal of the affected batch from the district's shelves, because a micronutrient shortfall in an infant food is not academically minor even if it is legally categorised as substandard. Document everything you were told and everything you decided, since a large company with a marginal deviation is the case most likely to be appealed.

You are the State Food Safety Commissioner. Your officers can inspect shops but have no capacity to monitor what manufacturers claim on e-commerce platforms, where most such marketing now happens. How do you address this with the resources you have?

Accept the constraint rather than pretending to a capability you do not have — a monitoring cell that exists on paper is worse than an acknowledged gap, because it stops anyone from solving the problem. Do the two things that scale without headcount: agree a standing arrangement with the major platforms that listings in the infant nutrition category carry only the approved label text, and publish the approved claim set so that compliance is checkable by anyone, including competitors, who are the most motivated inspectors you will ever have. Use your own limited staff for what only a public officer can do, which is sampling and laboratory testing, and route citizen complaints about listings through a simple reporting channel so that the public does the surveillance you cannot fund. Escalate to FSSAI the one thing that must be fixed centrally: a platform-level obligation, since a State-by-State approach to a national marketplace will fail.