- FSSAI has initiated three separate adjudication cases against Nestlé India.
- Two cases concern promotional claims involving NAN Excella Pro Stage 1 and Lactogen Pro 1.
- A separate follow-up formula sample was found not to meet the prescribed biotin requirement in two laboratory analyses.
India’s food safety regulator has initiated three adjudication cases against Nestlé India, bringing renewed attention to how infant nutrition products are marketed and whether their nutritional composition meets prescribed standards.
The Food Safety and Standards Authority of India (FSSAI) said it examined Nestlé’s infant nutrition products and promotional material available on e-commerce platforms. Its scrutiny covered NAN Excella Pro Stage 1, Lactogen Pro 1 and a follow-up formula.
For NAN Excella Pro Stage 1, FSSAI flagged claims relating to “5 HMOs” and “Whey Protein”. Lactogen Pro 1 carried a claim that its whey protein was “easy to digest”.
The regulator said the claims contravened Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional claims or material 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 restricts the advertising and promotion of such products.
Nestlé India has disputed the concerns and said its products comply with applicable regulations. The company also said the products and labels under scrutiny had been approved by an FSSAI expert committee.
“Our products are fully compliant with all the applicable regulations,” a Nestlé spokesperson said, adding that the company had submitted a detailed response to the authorities and that the statements on the labels were factual and supported by scientific literature.
The separate biotin finding
The third case involves a different issue from the promotional claims.
FSSAI said a sample of a Nestlé India follow-up formula was found to be substandard with respect to its biotin content during laboratory analysis. The sample was subsequently sent for re-analysis, and the referral laboratory also found that it did not meet the prescribed biotin requirement.
Biotin, also known as vitamin B7, is a water-soluble vitamin involved in the body's metabolism of carbohydrates, fats and proteins. Its level in infant nutrition products is regulated because these products are formulated to meet specific nutritional requirements.
However, the exact amount of biotin detected in the Nestlé sample has not been publicly disclosed in the information available so far.
That distinction is important. The finding means the tested sample did not conform to the applicable nutritional requirement. It does not, by itself, establish that the product is toxic or that consumers have suffered a health problem.
The regulator has also not announced a product ban as part of the action. The three cases remain within the adjudication process, where the alleged violations will be examined before any final regulatory consequences are determined.
Why infant formula faces tighter rules
The action highlights why infant nutrition is treated differently from ordinary packaged food.
Apart from meeting prescribed nutritional standards, infant food manufacturers face restrictions on promotional claims because of the sensitivity of the market and the importance of how products are presented to parents.
In this case, FSSAI's concerns span both sides of that equation: claims used to promote two products and the measured nutrient composition of another.
For parents, however, the latest action should not automatically be interpreted as a warning that all Nestlé infant products are unsafe. The cases concern specific products, claims and a particular laboratory finding.
Parents who are concerned about a particular formula should seek advice from a pediatrician before changing an infant's feeding routine, especially where the child has specific nutritional or medical needs.
Nestlé has said it will continue to work with FSSAI and adhere to applicable regulations. The final outcome will depend on the adjudication proceedings and any further findings by the competent authorities.
