India's food regulator has initiated legal action against Nestlé India over alleged non-compliance involving infant nutrition products, including NAN Excella Pro Stage 1, Lactogen Pro 1 and a follow-up formula. The Food Safety and Standards Authority of India (FSSAI) says it has filed three separate adjudication cases. Nestlé India disputes the allegations and says the products comply with applicable regulations.
What FSSAI found
The most significant laboratory finding concerns a sample of follow-up formula manufactured by Nestlé India. FSSAI said the sample was classified as sub-standard because it did not meet the prescribed requirement for biotin, also known as vitamin B7. The sample was sent for re-analysis and the referral laboratory also found it non-conforming with the required biotin level.
The regulator has not announced a recall in connection with the finding. The adjudication process will determine the regulatory outcome, so the initiation of proceedings should not be read as a final penalty or final judicial finding against the company.
Why NAN Excella Pro and Lactogen Pro are also under scrutiny
FSSAI also examined promotional material for NAN Excella Pro Stage 1 and Lactogen Pro 1 that was available on e-commerce platforms. The regulator flagged claims including references to "5 HMOs" and "Whey Protein" for NAN Excella Pro Stage 1, as well as a claim associated with Lactogen Pro 1 describing whey protein as easy to digest.
FSSAI says the disputed promotion contravenes restrictions applying to the promotion of infant nutrition products under India's Foods for Infant Nutrition Regulations, 2020 and the Infant Milk Substitutes, Feeding Bottles and Infant Foods law.
What Nestlé India says
Nestlé India has rejected the suggestion that its infant nutrition products are non-compliant. The company says NAN Excella Pro and Lactogen Pro and their labels were approved by an FSSAI expert committee. It also says it has submitted a detailed response to the authorities and maintains that the statements on the labels are factual and supported by scientific literature.
That distinction matters: FSSAI has begun adjudication proceedings, while Nestlé is contesting the regulator's position. The final outcome has not yet been determined.
Nestlé India shares react to the FSSAI action
The regulatory development also reached the stock market. Nestlé India shares fell nearly 3% intraday on September 18 as investors assessed the possible implications of the cases for one of the company's important product segments.
Part of a wider food-safety crackdown
The action comes during a broader period of tougher food-safety and labelling enforcement in India. Headline Thread previously examined FSSAI's wider crackdown on misleading claims, inspections and warning-label rules, which has put large packaged-food companies under increased scrutiny.
Food enforcement has also intensified at the state level. A recent Maharashtra FDA raid involving allegedly altered expiry dates illustrates the wider focus on product safety, traceability and consumer information.
What happens next
The three adjudication cases now move through the regulatory process, where Nestlé India's responses and FSSAI's findings can be considered before an outcome is reached. Consumers should distinguish that process from a product recall: FSSAI's announcement, as reported on September 18, did not say that the affected products had been recalled.
The key things to watch are whether FSSAI orders any corrective action or penalties, whether the disputed promotional language changes, and whether the regulator issues further directions concerning the follow-up formula sample. Any such step would be a material development beyond today's initiation of legal proceedings.
