FSSAI filed three cases against Nestle India for illegal promotional claims on two infant formulas and sub-standard Biotin levels in a third product, citing violations of the 2020 infant nutrition regulations and the IMS Act.
FSSAI filed three adjudication cases against Nestle India on 18 September 2026 after its surveillance found that two of the company's infant formula products carried promotional claims prohibited under Indian food law, and a third product failed mandatory nutrient tests.
The two products at the centre of the claims dispute are NAN Excella Pro Stage 1 and Lactogen Pro 1, both manufactured by Nestle India (a subsidiary of Swiss multinational Nestle S.A.). FSSAI found that both products displayed claims relating to '5 HMOs' (human milk oligosaccharides) and 'Whey Protein' in ways that contravene Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which bars promotional claims or material intended to increase the saleability of infant foods. The same conduct also violates Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (IMS Act), which prohibits the advertisement and promotion of such products. FSSAI sought clarifications from Nestle India before proceeding to file the adjudication cases.
Separately, a sample of a follow-up formula manufactured by Nestle India was found sub-standard with respect to Biotin content during laboratory analysis. A re-analysis test confirmed the finding: the product did not meet the prescribed Biotin requirement under the same 2020 infant nutrition regulations.
What changed, and why it matters
India's 2020 infant nutrition regulations tightened the rules that existed under the older IMS Act framework. Regulation 4(2) is specific: it does not merely prohibit false claims, it prohibits promotional claims altogether on infant foods, regardless of whether the underlying ingredient (HMOs, whey protein, or anything else) is scientifically legitimate. The intent is to prevent manufacturers from using nutrient callouts to market products to parents in a category where the World Health Organization recommends exclusive breastfeeding for the first six months of life.
HMOs are a class of complex carbohydrates found naturally in human breast milk. Manufacturers have increasingly added synthetic or fermentation-derived HMOs to formula and then front-labelled the count ('5 HMOs', '3 HMOs') as a selling point. Whether added HMOs in formula confer the same benefits as those in breast milk is still an active area of research. A 2023 review published in Nutrients found that some HMO supplementation in formula showed benefits for gut microbiota composition, but noted that long-term clinical outcomes remain insufficiently studied. Indian regulations do not wait for that debate to settle: the promotional restriction applies regardless.
The Biotin shortfall is a separate and more straightforward compliance failure. Biotin (vitamin B7) is a mandatory micronutrient in infant formula under the 2020 regulations because it supports fatty acid metabolism and neurological development in infants. A product that fails Biotin testing in both primary and re-analysis samples is sub-standard by definition, not by interpretation.
Nestle India has faced scrutiny in India before. In 2024, the Swiss-based NGO Public Eye and the International Baby Food Action Network (IBFAN) published a report alleging that Nestle added sugar to infant formula sold in lower-income countries, including India, while selling no-added-sugar versions in Europe. Nestle India disputed the characterisation at the time. The current FSSAI action is a domestic regulatory proceeding, not connected to that report, but it adds to a pattern of regulatory attention on the company's infant nutrition portfolio in India.
FSSAI has not publicly released the full adjudication schedule or the specific penalties being sought. Adjudication under the Food Safety and Standards Act, 2006 can result in financial penalties; criminal prosecution is a separate track. It is not yet clear whether FSSAI will order a product recall for the Biotin-deficient batch or require label changes on NAN Excella Pro Stage 1 and Lactogen Pro 1.
What parents and buyers should do
If you are currently using NAN Excella Pro Stage 1, Lactogen Pro 1, or any Nestle follow-up formula, the immediate practical step is to check the batch number on the packaging and watch for any FSSAI recall notice on the FSSAI official website. FSSAI has not issued a public recall as of 20 September 2026, but the Biotin sub-standard finding applies to at least one specific batch that was tested.
For parents choosing infant formula more broadly, the regulatory action is a reminder that front-of-pack claims on infant formula in India are legally restricted, not just ethically questionable. A product that says '5 HMOs' on the tin is already in a grey area under Indian law, whatever the science says about HMOs themselves. The number on the label is a marketing signal, not a clinical prescription.
Paediatricians and dietitians advising families on formula choice should note that FSSAI's clarification-and-adjudication process does not automatically mean the products are unsafe to use right now, but the Biotin deficiency finding is worth flagging to your doctor if your infant is on a Nestle follow-up formula and you are uncertain about the batch.
For anyone tracking clean-label and additive-free standards in the infant category: the 2020 FSS (Foods for Infant Nutrition) Regulations are the primary document to read. They set out permitted ingredients, mandatory nutrient ranges, and the promotional restrictions that FSSAI is now enforcing. The regulations are available on the FSSAI website and are more detailed than most brand communications suggest.