The food safety regulator found non-compliant biotin levels and misleading labeling on baby formulas.
On Friday, 18 September, the Food Safety and Standards Authority of India (FSSAI) announced legal action against Nestlé after finding an infant formula that did not meet required domestic standards. According to the regulator, a sample of the product showed levels of biotin, also known as vitamin B7, outside the parameters established by Indian law. A reanalysis of the sample confirmed the violation, though the authority did not state whether it would order a recall from store shelves.
The FSSAI also opened cases involving two other infant products, NAN Excella Pro Stage 1 and Lactogen Pro 1, alleging misleading information that breached domestic rules. In total, the food safety regulator initiated three separate actions against the Swiss company.
Nestlé stated that its products comply fully with all applicable standards and that it will continue working with Indian authorities, without commenting directly on the specific biotin test results. In response to the labeling allegations, Nestlé India said its labels are factual, backed by scientific studies, and were previously approved by an expert committee of the FSSAI itself.
The regulatory scrutiny follows separate infant formula recalls across more than 30 countries earlier this year. In January, Brazil's health regulator Anvisa banned certain batches of Nestlé brands, including Nestogeno, Nan Supreme Pro, Nanlac Supreme Pro, Nanlac Comfor, Nan Sensitive, and Alfamino, over contamination risks linked to cereulide, a toxin produced by Bacillus cereus bacteria sourced from a third-party supplier.
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