FSSAI files 3 cases against Nestlé India over infant nutrition product violations
Synopsis
India's top food regulator has opened three adjudication cases against Nestlé India — two over promotional claims on NAN Excella Pro and Lactogen Pro, and one over a sub-standard biotin reading in a Follow-up Formula. Nestlé insists its labels were FSSAI-approved and backed by science. The cases have no final penalty yet, but could reshape how infant nutrition products are marketed online.
Key Takeaways
FSSAI initiated three separate adjudication cases against Nestlé India on 18 September 2026 .
Complaints cover promotional claims on NAN Excella Pro Stage 1 (5 HMOs, Whey Protein) and Lactogen Pro 1 (easy-to-digest whey protein).
A third case relates to a Follow-up Formula sample found sub-standard for biotin content in two separate laboratory analyses.
The violations are alleged under Regulation 4(2) of the Foods for Infant Nutrition Regulations, 2020, and the IMS Act, 1992 .
No final penalty has been imposed; cases remain at the adjudication stage.
Nestlé India maintains its products are fully compliant and that labels were approved by FSSAI's own expert committee.
The Food Safety and Standards Authority of India (FSSAI) on Friday, 18 September 2026, initiated three separate adjudication cases against Nestlé India over alleged regulatory non-compliance involving infant nutrition products, including NAN Excella Pro Stage 1 and Lactogen Pro 1. The regulator flagged promotional claims on these products as potentially violating rules governing infant food marketing in India.
What FSSAI Found
According to a notice shared by the food regulator, FSSAI examined the products and their promotional material listed on e-commerce platforms. For NAN Excella Pro Stage 1, the authority raised concerns over claims related to '5 HMOs' and 'Whey Protein'. In the case of Lactogen Pro 1, FSSAI flagged a claim describing whey protein as being easy to digest.
The regulator said the products were found to be in contravention of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which places restrictions on promotional claims intended to increase the saleability of infant foods. FSSAI also cited Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which prohibits the advertisement and promotion of such products.
Biotin Non-Compliance in Follow-Up Formula
In a separate finding, FSSAI said a sample of a Follow-up Formula manufactured by Nestlé India was found to be sub-standard for its biotin content during laboratory analysis. The sample was subsequently sent to a Referral Laboratory for re-analysis, and the second test also returned a non-conforming result under the Foods for Infant Nutrition Regulations, 2020.
This biotin-related finding forms the basis of a separate adjudication case. Notably, the regulator's notice does not indicate that any final penalty has been imposed on Nestlé India — the three cases are currently at the adjudication stage.
Nestlé India's Response
Responding to the development, a Nestlé India spokesperson maintained that the company's 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,' the spokesperson said.
The company added: '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.'
Regulatory and Consumer Context
This comes amid heightened scrutiny of multinational food companies operating in India's infant nutrition segment. FSSAI has in recent years stepped up enforcement actions on product labelling and promotional practices, particularly for foods marketed to infants and young children — a demographic considered especially vulnerable under Indian food safety law.
Critics argue that self-regulatory claims by large corporations carry limited weight without independent audit mechanisms. The outcome of the three adjudication cases is expected to set a precedent for how infant nutrition marketing standards are enforced on digital platforms in India.
Point of View
Signalling that the regulator is extending its enforcement gaze beyond physical store shelves to digital storefronts. The biotin finding is arguably the more serious of the two issues: a nutritional non-conformance in an infant product, confirmed twice under referral lab conditions, is a direct safety concern. Nestlé's defence — that FSSAI's own expert committee approved the labels — creates a procedural paradox the adjudication process will need to resolve. More broadly, multinational infant nutrition brands have faced parallel scrutiny in Europe and the US over claims targeted at vulnerable demographics; India's action fits a global pattern, and its outcome will be watched closely by both the industry and child health advocates.
NationPress
18 Sept 2026
Frequently Asked Questions
What are the FSSAI adjudication cases against Nestlé India about?
FSSAI has initiated three adjudication cases against Nestlé India over alleged regulatory violations in infant nutrition products. Two cases relate to promotional claims on NAN Excella Pro Stage 1 and Lactogen Pro 1 that the regulator says contravene India's infant nutrition advertising rules; a third case concerns a Follow-up Formula found sub-standard for biotin content in laboratory testing.
Has any penalty been imposed on Nestlé India by FSSAI?
No final penalty has been imposed as of 18 September 2026. The three cases are at the adjudication stage, meaning the regulatory process is ongoing and a final determination is yet to be made.
What is Nestlé India's position on the FSSAI action?
Nestlé India has said its products are fully compliant with all applicable regulations. The company stated that the labels of NAN Excella Pro and Lactogen Pro were approved by FSSAI's own expert committee, and that it has submitted a detailed response to the authorities supporting its claims with scientific literature.
Which regulations did FSSAI cite in the cases?
FSSAI cited Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional claims on infant foods, as well as Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which prohibits advertisement of such products.
Why is the biotin finding significant?
Biotin is a nutritionally essential B-vitamin required for infant development, and its prescribed levels in follow-up formula are set under the Foods for Infant Nutrition Regulations, 2020. The finding was confirmed by a second Referral Laboratory, making it a double-verified non-compliance — potentially the most serious of the three cases since it involves a nutritional adequacy standard rather than a labelling claim.
