FSSAI moves against Nestlé over baby formula claims and biotin test

What did FSSAI flag?

For NAN Excella Pro Stage 1, the FSSAI flagged claims relating to whey protein and five human milk oligosaccharides (HMOs), complex sugars naturally present in human breast milk. In the case of Lactogen Pro 1, the regulator raised concerns over a claim relating to whey protein, including its digestibility.

The FSSAI said such promotional claims are not permitted under India’s regulations governing foods for infant nutrition. The rules prohibit pictures, graphics or phrases intended to increase the saleability of infant milk substitutes or infant food. They also prohibit terms such as “Humanised” and “Maternalised”, as well as similar expressions.

The restrictions are part of a broader regulatory framework governing the marketing of infant milk substitutes in India.

The development has been welcomed by Dr Arun Gupta, chief coordinator of the Breastfeeding Promotion Network of India (BPNI) and one of the people involved in efforts surrounding the IMS Act. “This is a very encouraging development; they should pursue these cases,” Gupta said.

He said regulatory action was important because complaints relating to the promotion of infant formula had been made in the past, but did not always result in proceedings. “Nestlé certainly is one of the bigger producers of infant formula and this also sends a signal to the other companies to follow suit,” he said.

Why are infant formula advertisements so tightly regulated?

India has had restrictions on the promotion of infant milk substitutes for decades. The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, commonly known as the IMS Act, places restrictions on advertising and promotion of such products.

The law is intended to prevent marketing practices that could undermine breastfeeding or create the impression that infant milk substitutes are equivalent or superior to breast milk.

The FSSAI has cited both the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 and the IMS Act in the action against Nestlé.

Separate concern over biotin

The third case concerns a follow-up formula; a product intended for older infants and children after the initial infant-formula stage. The FSSAI said a sample was found to be non-conforming with respect to its biotin content. Biotin, also known as vitamin B7, is a water-soluble vitamin involved in several metabolic processes.

The regulator said the sample was sent for re-analysis and that the referral laboratory also found it to be non-conforming. According to the applicable standards cited in the proceedings, infant food is required to contain 7.5 to 50 micrograms of biotin. The finding led to a separate case against Nestlé.

Nestlé says products comply with regulations

Nestlé India has said that its products comply with applicable regulations. The company has also indicated that the labels under scrutiny had been scientifically validated and approved by the FSSAI’s expert committee, and that it has submitted a detailed response to the regulator.

The company’s position is significant because the FSSAI proceedings are still at the regulatory stage. The initiation of a case does not by itself establish a final violation or mean that a penalty has already been imposed.

Why the scrutiny matters

Infant formula occupies a particularly sensitive area of food regulation because decisions about infant feeding have implications for both nutrition and breastfeeding practices. The latest action also comes amid increased scrutiny of infant nutrition products and their marketing. A 2024 investigation by Swiss NGO Public Eye reported differences in the sugar content of some Nestlé infant formula and baby-food products sold in lower-income countries, including India, compared with products sold in European markets.

Nestlé has previously maintained that its products comply with applicable Indian regulations and standards. The three cases initiated by the FSSAI will now go through the regulatory process. Their outcome will determine whether any violations are established and what action, if any, follows.