Food regulator flags promotional claims on two infant formula products and non-conforming biotin levels in a follow-up formula sample
The Food Safety and Standards Authority of India (FSSAI) has initiated three separate adjudication cases against Nestlé India over alleged regulatory violations involving its infant nutrition products, including NAN Excella Pro Stage 1 and Lactogen Pro 1. The third case relates to a follow-up formula sample that was found to have non-conforming levels of biotin.
The regulator’s action follows its examination of Nestlé’s products and promotional material available on ecommerce platforms. Two cases concern claims made in relation to infant formula products, while the third involves laboratory findings related to the nutritional composition of a follow-up formula.
FSSAI Flags Promotional Claims
For NAN Excella Pro Stage 1, FSSAI raised concerns over claims relating to whey protein and five human milk oligosaccharides (HMOs). In the case of Lactogen Pro 1, the regulator questioned a claim concerning the digestibility of its whey protein.
FSSAI said such promotional claims are restricted under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The regulatory framework places specific restrictions on promotional material intended to increase the saleability of infant milk substitutes and infant foods.
The action also refers to the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which restricts the advertising and promotion of infant milk substitutes and certain infant foods.
Follow-Up Formula Fails Biotin Test
The third case concerns a follow-up formula, a product intended for infants and young children after the initial infant-formula stage.
According to FSSAI, 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 sample was subsequently sent for re-analysis, with the referral laboratory also finding it non-conforming with the prescribed biotin requirements under India’s infant nutrition regulations. The applicable standards specify a biotin range of 7.5 to 50 micrograms for infant food.
Nestlé Says Products Comply With Regulations
Nestlé India has maintained that its products comply with all applicable regulations and said it would continue to work with FSSAI.
The company said the products and labels under scrutiny had been approved by FSSAI’s expert committee. It has also submitted a detailed response to the authorities, stating that the claims appearing on the labels are factual and supported by scientific literature.
The cases are currently part of the adjudication process. The initiation of proceedings does not by itself establish a final violation or indicate that a penalty or product recall has been ordered.
Increased Scrutiny Of Infant Nutrition
The action comes amid heightened regulatory scrutiny of food safety and product claims in India’s food industry. Infant nutrition products are subject to particularly stringent requirements covering both their nutritional composition and marketing.
The FSSAI has not indicated whether the finding concerning the follow-up formula will result in a product recall. The three adjudication proceedings will determine whether the alleged violations are established and what regulatory action, if any, follows.
