The Food Safety and Standards Authority of India (FSSAI) said on Friday that laboratory testing had found a sample of Nestlé’s follow-up formula — a milk-based product intended for infants — to be substandard with respect to biotin.
Biotin, also known as vitamin B7, is a nutrient for which India’s food regulator has prescribed a standard reference range for infant food products.
The regulator said a subsequent analysis of the sample also found it to be “non-conforming” with prescribed biotin requirements under Indian law.
“a re-analysis” of the sample found it was “non-conforming” with respect to prescribed biotin requirements under Indian laws, the FSSAI said in a social media post.
The authority did not immediately indicate whether the product would be recalled from the Indian market.
Nestlé Faces Three Cases
The regulatory action extends beyond the biotin finding. The FSSAI said it had also initiated proceedings against Nestlé over two other baby food products — NAN Excella Pro Stage 1 and Lactogen Pro 1 — alleging that they contained misleading claims in violation of food regulations.
“Three separate adjudication cases have been filed against Nestle,” the FSSAI said.
Nestlé, however, rejected any suggestion that its products failed to meet applicable standards, saying its products comply with regulations.
The company said its products are “fully compliant with all the applicable regulations” and that it would continue working with the regulator. It did not specifically address the finding concerning the substandard sample.
Responding to the allegations over product labelling, Nestlé India said it had again submitted a detailed response to the authorities.
The company said the statements appearing on the labels “are factual in nature, and supported by scientific literature.”
The labels “were approved by the expert committee of FSSAI,” Nestlé India added.
The development weighed on Nestlé’s shares in India, which fell almost 3 per cent following news of the regulatory action.
India Remains Key Growth Market
The dispute comes at an important time for Nestlé, which regards India as one of its major growth markets.
Milk and nutrition products, including infant formula and baby foods, represented Nestlé India’s largest revenue category in the financial year ended March 2026. The category accounted for about one-third of the company’s product sales, which were valued at $2.4 billion.
The action is also part of a wider crackdown by Indian authorities on the country’s food industry, a market estimated at about $100 billion.
The campaign has included surprise inspections of manufacturing facilities and increased testing of food products as authorities step up scrutiny of food safety and regulatory compliance.
Nestlé’s Previous Regulatory Dispute
The latest action is not Nestlé’s first major confrontation with Indian food regulators.
In 2015, Indian authorities banned the company’s popular Maggi noodles after tests allegedly found excessive levels of lead and regulators raised labelling concerns. The ban resulted in a large-scale recall of the product from the market.
Maggi subsequently returned to Indian shelves after fresh testing.
The latest case comes amid an intensifying debate over food safety and labelling requirements in India. The debate gained further attention after Reuters reported last month that the government had adopted a weaker labelling regime following lobbying by Coca-Cola and groups representing or supporting Nestlé and PepsiCo.
The companies and industry groups had argued that warning labels were ineffective, according to the report.
Several companies, however, have voluntarily adopted stronger food-labelling measures in European markets, highlighting differences in regulatory approaches between markets.
For Nestlé, the latest proceedings create another regulatory challenge in a market that remains strategically important to the company, while Indian authorities continue to intensify scrutiny of food products and their labelling.