FSSAI Flags Nestlé Infant Food Products Over Biotin Levels; What Parents Need to Know

Choosing an infant formula can be difficult for parents, particularly when product labels contain numerous nutritional claims and ingredient details.

The Food Safety and Standards Authority of India (FSSAI) has initiated legal proceedings against Nestlé India over alleged violations involving three infant nutrition products. The regulatory action covers promotional claims made for two products as well as a laboratory finding concerning the biotin content of a follow-up formula.

The products under scrutiny include NAN Excella Pro Stage 1, Lactogen Pro 1 and a Nestlé follow-up formula. FSSAI has filed three separate adjudication cases, indicating that the issues relate to different aspects of regulatory compliance rather than a single product-safety concern.

What Has FSSAI Flagged?

FSSAI reviewed NAN Excella Pro Stage 1 and Lactogen Pro 1, including promotional content displayed on e-commerce platforms.

In the case of NAN Excella Pro Stage 1, the regulator raised objections to promotional references to “5 HMOs” and “Whey Protein.” For Lactogen Pro 1, FSSAI questioned the claim that its whey protein was “easy to digest.”

According to the regulator, these claims were not in compliance with Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The provision places restrictions on promotional claims and material designed to enhance the saleability of infant food products.

FSSAI also referred to provisions of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which regulates the advertising and promotion of infant milk substitutes and related products.

Biotin Content Found Non-Compliant

A separate case concerns a follow-up formula manufactured by Nestlé India. During laboratory testing, a sample was found not to comply with the prescribed biotin requirement.

The sample was subsequently sent to a Referral Laboratory for re-analysis, where it was again found to be non-conforming with the applicable standard.

Under FSSAI regulations, follow-up formula is required to contain between 7.5 and 50 micrograms of biotin per 100 grams of product, equivalent to 1.6 to 10.6 micrograms per 100 kcal. The specific amount of biotin detected in the Nestlé sample has not been publicly disclosed.

The classification of a product as “substandard” in this context means that its measured composition did not meet the regulatory specification. It does not automatically mean that the product is toxic or that consumption would necessarily result in a health problem.

Why Does Biotin Matter?

Biotin, also known as vitamin B7, is a water-soluble B vitamin involved in the metabolism of carbohydrates, fats and proteins. It contributes to normal metabolic functions in the body.

For infant nutrition products, nutrient levels are regulated because infants may depend on these products for a significant part of their nutritional intake. Manufacturers therefore have to meet prescribed standards for several nutrients, including biotin.

The FSSAI finding is consequently about compliance with the required nutritional composition and should not be interpreted as a finding that biotin itself is harmful.

What Should Parents Know?

The regulatory action involves adjudication proceedings over alleged non-compliance. The filing of such cases does not, by itself, mean that all batches of the products are unsafe or that the products have been banned.

Parents should also distinguish between regulatory findings and promotional claims when evaluating infant formula. Marketing statements about ingredients, protein sources or digestibility should not be the sole basis for deciding which formula is appropriate for a baby.

Formula should be selected according to the infant’s age and nutritional requirements. Parents of babies with feeding problems, allergies, medical conditions or other specific nutritional needs should consult a paediatrician before changing formula.

FSSAI has initiated three separate adjudication cases involving the Nestlé products. The proceedings will determine what regulatory action, if any, follows. At present, the key issues identified by the regulator are promotional claims concerning two products and a biotin-content non-compliance finding involving a sample of a follow-up formula.

The precise laboratory value for the biotin finding has not been publicly disclosed, although the applicable regulatory range has been specified.

Disclaimer: This article is based on available regulatory findings and reported information at the time of publication. Parents should seek advice from a qualified paediatrician for individual infant-feeding decisions or health concerns.