IN Brief:
- FSSAI has filed three adjudication cases involving two infant-nutrition promotional claims and one follow-up formula sample.
- Reanalysis found the sampled follow-up formula did not conform to the prescribed biotin requirement.
- Nestlé says its products comply with applicable regulations and says the disputed product labels had previously received expert-committee approval.
Nestlé India is facing three adjudication cases from India’s food regulator involving infant-nutrition products, including two cases over promotional claims and another relating to a follow-up formula sample found non-conforming for biotin.
The Food Safety and Standards Authority of India said it had filed three separate cases after reviewing products and associated claims. Nestlé maintains that its products comply with applicable regulations and has submitted responses to the authorities.
Two proceedings concern NAN Excella Pro Stage 1 and Lactogen Pro 1. FSSAI says claims made in connection with the products breached restrictions applying to the promotion of infant foods.
The third case concerns product composition rather than marketing. FSSAI said a sample of follow-up formula was found to be substandard with respect to biotin, or vitamin B7, against the prescribed Indian requirements.
The sample was subsequently reanalysed, with the regulator reporting that the second assessment also found it non-conforming for the specified biotin requirement. FSSAI has not announced a recall in connection with the finding.
Nestlé said its products are fully compliant with applicable regulations and that it will continue working with the regulator. In relation to the disputed statements on labels, the company said they were factual, supported by scientific literature, and had previously been approved by an FSSAI expert committee.
The regulator’s filing does not itself resolve those disagreements. Adjudication provides the process through which the alleged regulatory breaches can be considered, leaving the respective positions of FSSAI and Nestlé to be tested through the applicable proceedings.
The composition case nevertheless carries a direct manufacturing dimension. Infant and follow-up formula operate under detailed nutritional specifications, requiring manufacturers to control micronutrient addition within prescribed ranges while accounting for ingredient variability, processing, storage, and analytical tolerances.
Biotin is required in very small quantities compared with the principal ingredients in a formula. That makes accurate premix preparation, dosing, mixing, sampling, and laboratory verification important because small deviations can be material against a regulatory specification.
Manufacturers also need batch-level traceability connecting ingredient lots, premixes, production conditions, test results, and finished packs. Where a regulator identifies a non-conforming sample, those records provide the basis for determining whether the result relates to an isolated batch, analytical variation, ingredient control, or a wider process issue.
The promotional cases involve a separate compliance system. Infant-nutrition rules impose controls that extend beyond standard food labelling, with particular restrictions around claims and promotion because of public-health policies designed to protect breastfeeding.
That means formula manufacturers need regulatory control over both the physical product and the information associated with it. Packaging copy, approved label artwork, websites, retailer descriptions, and e-commerce listings can all create regulatory exposure even where the recipe itself is unchanged.
Digital sales channels add another layer because product information can be amended separately from printed packaging. Manufacturers consequently need processes for ensuring that online claims remain aligned with approved product documentation and with the restrictions applying to infant foods.
The present FSSAI action covers both sides of that compliance structure. One proceeding concerns a measured nutrient result from a follow-up formula, while the other two concern statements associated with infant-nutrition products.
Nestlé India’s exposure to the category is commercially significant. Milk and nutrition products, including infant formula and baby food, were its largest revenue category in the financial year ending March 2026, accounting for around a third of product sales according to Reuters.
The cases therefore involve a tightly regulated product category that is also material to the company’s Indian business. They do not, however, establish that Nestlé’s wider infant-nutrition range is non-compliant, and the company disputes the regulatory concerns raised.
For production teams, the compositional case reinforces the need for control at micronutrient level as well as conventional food-safety parameters. Premix specification, weighing, mixing homogeneity, laboratory methods, release testing, and retained samples all become important where compliance can turn on a nutrient present at low concentration.
The adjudication process will determine the legal outcome of the three cases. Until then, the confirmed position is that FSSAI has initiated proceedings, a reanalysed follow-up formula sample was reported as non-conforming for biotin, and Nestlé says its products comply with the applicable regulations.
