FSSAI has initiated three adjudication cases against Nestlé India over alleged regulatory concerns involving baby formula claims and biotin levels, while Nestlé maintains that its products comply with applicable regulations.
The Food Safety and Standards Authority of India (FSSAI) has initiated three separate adjudication cases against Nestlé India over alleged regulatory non-compliance involving its infant nutrition products. The action concerns promotional claims made for two baby formula products and a separate laboratory finding related to biotin content in a follow-up formula.
The food regulator examined Nestlé's infant nutrition products and promotional material available on e-commerce platforms. Its action involves NAN Excella Pro Stage 1, Lactogen Pro 1 and a follow-up formula.
For NAN Excella Pro Stage 1, FSSAI raised concerns over promotional claims referring to “5 HMOs” (human milk oligosaccharides) and whey protein. HMOs are complex sugars naturally found in human breast milk. In the case of Lactogen Pro 1, the regulator flagged a claim describing its whey protein as “easy to digest.”
According to FSSAI, the promotional material for the two products did not comply with Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The regulation places restrictions on promotional claims or material intended to increase the saleability of infant foods.
Infant nutrition products are subject to strict rules in India because of their connection with infant feeding and breastfeeding practices. The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, commonly known as the IMS Act, also restricts advertising and promotion of infant milk substitutes and specified infant foods.
The regulations are designed to prevent marketing practices that could encourage inappropriate promotion of infant milk substitutes or create misleading comparisons with breastfeeding.
The third case involves a follow-up formula, which is intended for older infants and children after the initial infant-formula stage.
FSSAI said a sample of the product was found to be non-conforming with prescribed biotin requirements during laboratory testing. Biotin, also known as vitamin B7, is a water-soluble vitamin involved in several metabolic processes.
The sample was subsequently sent for re-analysis, but the referral laboratory also found it to be non-conforming with the applicable biotin requirement. Under the standards cited by FSSAI, infant food is required to contain 7.5 to 50 micrograms of biotin.
Nestlé India has rejected concerns about regulatory non-compliance and said its infant nutrition products are fully compliant with applicable regulations.
The company said the NAN Excella Pro and Lactogen Pro products and their labels had been approved by an FSSAI expert committee. Nestlé also said the claims questioned by the regulator were factual, scientifically supported and that it had submitted a detailed response to the authorities.
The three cases are currently part of the regulatory adjudication process. The initiation of cases does not by itself establish a final violation or indicate that a final penalty has been imposed. The outcome will depend on the proceedings before the designated authorities.
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