New Delhi: The Food Safety and Standards Authority of India (FSSAI) has initiated legal action against Nestlé India Ltd in three cases involving alleged promotional violations and nutritional non-compliance in its infant food portfolio, the top food regulator said in an Instagram post on Friday.
Nestle India said it remains compliant with all applicable regulations in the country.
The legal proceedings involve promotional claims made for two infant formula brands, NAN Excella Pro Stage 1 and Lactogen Pro 1, along with a follow-up formula sample that failed to meet prescribed nutritional parameters in laboratory tests.
“FSSAI examined the mentioned infant nutrition products and their promotional material available on e-commerce platforms,” the FSSAI said. The regulator stated that specific claims used in marketing the formulas were found to be non-compliant. “In NAN Excella Pro Stage 1, claims relating to ‘5 HMOs’ and ‘Whey Protein’ were observed, while in Lactogen Pro 1, a claim relating to ‘Whey Protein’ being easy to digest was observed. Accordingly, clarifications were sought from M/s Nestlé India Limited regarding the above claims,” the FSSAI said.
5-HMOs stands for five specific human milk oligosaccharides—complex, indigestible sugars naturally found in high concentrations in mother’s milk.
The regulator concluded that these promotional claims breach established statutory norms governing infant foods.
“Both products were found to be in contravention of Regulation 4(2) of the FSS (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional claims/material intended to increase the saleability of infant foods, and Section 3 of the IMS Act, 1992, which prohibits their advertisement and promotion,” the FSSAI said.
The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, or IMS Act, aims to promote breastfeeding and regulate the commercial production, supply, and distribution of baby food products.
A Nestlé India spokesperson said: “Our products are fully compliant with all the applicable regulations. The said products (i.e., NAN Excella Pro & Lactogen Pro) and their labels were approved by the expert committee of FSSAI. In response to the notice, we have again submitted our detailed response to the authorities regarding statements appearing on the label, which are factual in nature, and supported by scientific literature. We confirm to adherence of all regulations including all norms and label declarations as per applicable laws. We will continue to work closely and support FSSAI in its efforts towards consumer awareness.”
Shares of Nestle India settled about 1.4% lower at ₹1,353.10 apiece on the BSE on Friday.
Beyond advertising infringements, reported that laboratory testing detected a deficiency in the nutrient profile of another product. “A sample of Follow-up Formula manufactured by M/s Nestlé India Limited was found sub-standard with respect to Biotin content during laboratory analysis,” the FSSAI said.
This finding was subsequently confirmed through secondary referral testing. “The sample was subsequently referred for re-analysis, and the Referral Laboratory also found the sample non-conforming with respect to the prescribed Biotin requirement under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020,” the FSSAI said.
Consequently, the authority sanctioned formal legal proceedings against the company. “In view of the above contraventions, three separate adjudication cases have been filed against M/s Nestlé India Limited in respect of the three products,” the FSSAI said.
Dr. Sanjeev Bagai, paediatrician and chairman of Nephron Clinic in Delhi, cautioned against marketing claims promoting whey protein concentrates and synthetic additives in infant food.
“Marketing claims that these formulations are ‘easy to digest’ are simply not true. When a child has a normal, healthy gut capable of digesting regular milk, why give ultra-processed protein? There are no long-term studies proving the safety or benefits of ingredients like 5-HMOs or excess biotin in babies,” Dr. Bagai said.
“Using such high concentrations of whey protein—ranging from 70% to 80% and going up to over 90%—in unregulated amounts can cause serious damage to an infant’s developing liver and kidneys. Excess amounts disrupt natural metabolism. Formula milk is not meant for routine consumption; it is strictly indicated only when there is a clear medical necessity,” Dr. Bagai added.
Nestlé has been under scrutiny since 2024, when international investigative reports flagged high sugar content in its infant cereals and baby food sold in low- and middle-income countries, including India. Those findings had prompted regulatory examination into the company’s infant nutrition portfolio.
India’s and infant nutrition market was valued at approximately $9.92 billion in 2025 and is projected to rise to $13.89 billion by 2031, according to data from Ken Research. Within the category, infant milk formula forms the single largest segment, accounting for nearly 45% of the total market.