FSSAI files three cases against Nestlé India over infant nutrition products

MUMBAI: The Food Safety and Standards Authority of India (FSSAI) has filed three separate adjudication cases against Nestlé India over three infant nutrition products, citing a substandard laboratory finding for one product and alleged promotional violations involving two others.

According to FSSAI, a sample of a follow-up formula manufactured by Nestlé was found to be substandard for biotin content during laboratory analysis. The sample was subsequently sent for re-analysis, with the referral laboratory also finding it non-confirming with the prescribed biotin requirement under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.

Biotin, also known as vitamin B7, is subject to prescribed reference levels under the regulations governing infant foods.

FSSAI also flagged promotional material relating to two other products, NAN Excella Pro Stage 1 and Lactogen Pro 1.

The regulator said both products were found to be in contravention of Regulation 4(2) of the Foods for Infant Nutrition Regulations, 2020, which restricts promotional claims or material intended to increase the salability of infant foods.

FSSAI also cited Section 3 of the Infant Milk Substitutes Act, 1992, which prohibits the advertisement and promotion of infant milk substitutes.

Nestlé India said its products are “fully compliant with all the applicable regulations” and that it would continue to work closely with FSSAI.

On the two products cited for promotional violations, a Nestlé India spokesperson said their labels had been approved by the regulator’s expert committee.

“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 did not directly address FSSAI’s claims concerning the third product.

Nestlé India’s shares fell almost 3 per cent following news of the regulatory action, before recovering to close nearly flat.

The regulatory action comes as milk and nutrition products, including infant formulas and baby foods, remain Nestlé India’s largest product category.

For the year ended March 2026, the category accounted for about a third of the company’s product sales, which stood at around $2.4 billion, or Rs 23,000 crore.

The latest action also adds to Nestlé’s history of regulatory scrutiny in India. In 2015, its Maggi noodles were banned following concerns over alleged excess lead levels and labelling, resulting in a nationwide recall. The product returned to shelves after subsequent testing.

For now, the three adjudication cases put the spotlight back on the regulatory framework governing infant nutrition products and how manufacturers market them in India.