The Food Safety and Standards Authority of India (FSSAI) has initiated three separate cases against Nestlé India over alleged regulatory violations involving infant nutrition products. The action covers promotional claims made for two baby food products and a separate issue involving the biotin content of a follow-up formula.
The regulator examined products and promotional material available on e-commerce platforms before taking action. The cases involve NAN Excella Pro Stage 1, Lactogen Pro 1 and a follow-up formula.
Two cases relate to the way NAN Excella Pro Stage 1 and Lactogen Pro 1 were promoted. FSSAI has questioned claims associated with five human milk oligosaccharides, or HMOs, and whey protein in NAN Excella Pro Stage 1.
HMOs are complex sugars naturally found in breast milk and are increasingly used in infant nutrition products. FSSAI has also objected to a claim on Lactogen Pro 1 that described its whey protein as easy to digest.
The regulator has said such promotional claims are restricted under India’s rules governing infant food and milk substitutes. These rules are designed to ensure that marketing does not encourage the sale of infant milk substitutes through claims or presentation that could influence parents’ feeding choices.
The issue is particularly sensitive because infant formula is not treated like an ordinary packaged food in India. The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, places strict limits on advertising and promotion of these products.
The Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, provide additional requirements for infant nutrition products. Together, the rules cover areas including labelling, nutritional composition and promotional claims.
The third case involves a different concern. FSSAI said a sample of a Nestlé follow-up formula was found to have non-conforming levels of biotin during laboratory testing. The sample was subsequently sent for re-analysis, and the referral laboratory also found that it did not meet the prescribed requirement.
Biotin, also known as vitamin B7, is a water-soluble vitamin that plays a role in several metabolic processes. Infant foods are required to meet specified nutrient levels because babies and young children have particular nutritional requirements during early growth.
The biotin finding is separate from the promotional claims involving NAN Excella Pro Stage 1 and Lactogen Pro 1. One set of cases concerns how products were marketed, while the other concerns the nutritional composition of a tested sample.
Nestlé India has rejected any suggestion that its infant nutrition products do not comply with regulations. The company has said NAN Excella Pro and Lactogen Pro are fully compliant with applicable requirements. It has also said the labels under scrutiny were approved by an FSSAI expert committee and that the claims were supported by scientific evidence.
The company has said it will continue to cooperate with the regulator and has submitted its response to the proceedings.
The cases are now part of the regulatory adjudication process. The initiation of legal action does not, by itself, amount to a final finding of guilt or establish that the products are unsafe. The proceedings will determine whether the alleged violations are established and whether any penalty or further action is required.
The development has brought fresh attention to the importance of labelling and marketing in India’s infant nutrition market. Parents often rely on information printed on packaging or displayed on shopping websites when choosing formula and other baby food products. Claims about digestion, nutrients and ingredients can therefore have a direct influence on how a product is perceived.
The FSSAI action also highlights the growing importance of monitoring online marketplaces. Product descriptions and promotional material on e-commerce platforms can reach consumers just as directly as advertisements or packaging. Regulators are increasingly examining such information as part of food safety and compliance checks.
Nestlé has faced regulatory scrutiny in India before, most notably during the 2015 Maggi noodles controversy. That episode involved allegations over lead levels and resulted in a temporary ban on the product before it returned to the market after subsequent testing and legal proceedings. The present matter concerns infant nutrition and involves different regulatory questions.
The latest action comes as food safety authorities continue to focus on product standards, labelling and claims made to consumers. Infant nutrition remains one of the most closely regulated parts of the food sector because of the vulnerability of the consumers involved.
The outcome of the three FSSAI cases will determine what action, if any, Nestlé India faces. Until then, the regulator’s allegations and the company’s response remain part of an ongoing legal and regulatory process.
