⁠FSSAI Initiates Three Adjudication Cases Against Nestle India Over Infant Food Regulatory Violations

The Food Safety and Standards Authority of India (FSSAI) has initiated legal action against Nestle India over alleged non-compliance involving two of its infant nutrition products, NAN Excella Pro Stage 1 and Lactogen Pro 1, and a separate finding that a follow-up infant formula manufactured by the company failed to meet prescribed biotin standards.

The Claims Under Scrutiny

The regulator said the action follows an examination of the two products and their promotional material available on e-commerce platforms. For NAN Excella Pro Stage 1, FSSAI flagged claims relating to "5 HMOs" and "Whey Protein" printed on the packaging and used in online promotion. For Lactogen Pro 1, the authority raised concerns over a claim describing the product's "Whey Protein" as easy to digest.

According to FSSAI, both sets of claims place the products in contravention of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The provision restricts promotional claims and material intended to increase the saleability of infant foods, reflecting a regulatory concern that marketing should not influence infant feeding choices away from breastfeeding or clinically appropriate nutrition.

The regulator also invoked Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, a standalone statute that prohibits the advertisement and promotion of infant milk substitutes, feeding bottles and infant foods. The 1992 law was enacted to curb aggressive marketing by infant food manufacturers and is often read alongside food safety regulations to restrict claims that nudge consumers toward formula feeding.

FSSAI said it has sought clarifications from Nestle India regarding both sets of claims, indicating that the company will have a formal opportunity to respond before the matter proceeds further.

The Biotin Finding and Adjudication Cases

Separately, and independent of the labelling dispute, a sample of a follow-up formula manufactured by Nestle India was found to be sub-standard for its biotin content during routine laboratory analysis. Biotin, a B-vitamin, is among the nutrients mandated under the 2020 regulations for follow-up formula meant for infants transitioning beyond exclusive milk feeding. When the initial finding was challenged, the sample was sent for re-analysis to a referral laboratory as an additional layer of scrutiny. However, the referral laboratory also found the sample non-conforming with the prescribed biotin requirement, effectively confirming the original result.

In view of these findings, FSSAI said three separate adjudication cases have been filed against Nestle India. Two relate to the promotional claims on NAN Excella Pro Stage 1 and Lactogen Pro 1, while the third concerns the biotin shortfall in the follow-up formula sample. The cases will proceed independently before the adjudicating authority, though they stem from the same scrutiny of the company's infant nutrition portfolio.

The action places renewed regulatory focus on how infant food companies market ingredient-level claims such as HMOs, short for human milk oligosaccharides, and whey protein formulations, both of which have become common selling points in premium infant formula in recent years. Regulators globally have grown more cautious about such claims, given concerns that they can be used to suggest formula is comparable or superior to breastfeeding, which national nutrition policy continues to prioritise for infants.

Nestle India has not yet issued a public response to the adjudication cases.

Inputs from TOI