Choosing the right infant formula can be challenging for parents, especially with products carrying numerous nutritional claims and ingredient-related information. A recent regulatory action involving Nestlé India has brought attention to both product composition and the way infant nutrition products are promoted.
The Food Safety and Standards Authority of India (FSSAI) has initiated three separate adjudication cases against Nestlé India over alleged regulatory violations involving two infant nutrition products and a follow-up formula. The cases concern promotional claims made for two products and a laboratory finding related to the biotin content of another product.
The products examined include NAN Excella Pro Stage 1, Lactogen Pro 1 and a Nestlé follow-up formula.
What Has FSSAI Flagged?
The three cases involve separate issues and do not represent a single finding covering all the products.
For NAN Excella Pro Stage 1 and Lactogen Pro 1, FSSAI examined promotional material available on e-commerce platforms. The regulator raised concerns over claims associated with the products.
For NAN Excella Pro Stage 1, the claims referring to “5 HMOs” and “Whey Protein” were flagged. In the case of Lactogen Pro 1, FSSAI questioned the claim that its whey protein was “easy to digest.”
According to the regulator, these claims were in violation of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The provision places restrictions on promotional claims and material intended to increase 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 such products.
Biotin Finding in Follow-Up Formula
The third case relates to the nutritional composition of a Nestlé follow-up formula. A laboratory examination found that a sample did not meet the prescribed requirement for biotin.
The sample was subsequently sent to a Referral Laboratory for re-analysis, which also found it to be non-conforming with the specified standard.
Under FSSAI’s requirements, follow-up formula must contain between 7.5 and 50 micrograms (µg) of biotin per 100 grams of product. This corresponds to 1.6 to 10.6 µg per 100 kcal.
The specific amount of biotin detected in the Nestlé sample has not been publicly disclosed.
In this context, describing the sample as “substandard” means that its measured biotin content did not fall within the prescribed regulatory range. The finding by itself does not mean that the product was toxic or that consuming it would necessarily result in biotin deficiency.
Why Biotin Matters in Infant Nutrition
Biotin, also known as vitamin B7, is a water-soluble B vitamin involved in the body’s use of carbohydrates, fats and proteins. It also contributes to normal metabolic processes.
For infant formula, nutrient levels are governed by prescribed standards rather than being determined solely by manufacturers. These requirements are intended to ensure that infant nutrition products meet specified nutritional compositions, including the required level of biotin.
As a result, the FSSAI finding relates to whether the sampled product met the required nutritional specification. It does not suggest that biotin itself is harmful.
What Should Parents Keep in Mind?
The FSSAI action involves adjudication proceedings concerning alleged non-compliance. The filing of a case does not, by itself, establish that every batch of the products is unsafe or that the products have been banned.
Parents should also be cautious about making feeding choices solely on the basis of marketing claims about ingredients or digestibility. Formula should be appropriate for the baby’s age and nutritional requirements.
If a baby has feeding difficulties or specific medical needs, parents should discuss any change in formula with a paediatrician.
FSSAI has filed three separate adjudication cases. The proceedings will determine what regulatory action, if any, follows. For parents, the key issues raised so far are the promotional claims associated with two products and the biotin-related non-compliance found in a sample of a follow-up formula. The precise laboratory result for biotin has not been publicly disclosed, while the applicable regulatory range has been specified.