India regulator sues Nestlé over infant formula claims and labeling

The Food Safety and Standards Authority of India (FSSAI) has initiated legal action against Nestlé India over three infant formula products, alleging violations of promotional claims and labeling standards. The regulator highlighted problems in NAN Excella Pro Stage 1 and Lactogen Pro 1 related to claims about 5HMOs and whey protein, along with a follow-up formula containing non-compliant levels of biotin.
The FSSAI’s concerns stem from Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional claims intended to drive sales. It also invoked Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992, prohibiting any advertising or promotion of such products. Laboratory testing confirmed that the follow-up formula fell short of required biotin standards, a result later verified by a second examination.
The regulator has filed three separate adjudication cases against Nestlé India for these violations. However, the company maintains its products and labeling comply with FSSAI guidelines, asserting that its disputed claims are backed by scientific evidence. Nestlé India submitted a detailed response to the regulator to support its position.
This is the second major regulatory dispute between FSSAI and Nestle India. In 2015, the FSSAI ordered a nationwide recall of Nestlé India’s Maggi instant noodles due to lead contamination, though the ban was later reversed after the product passed further testing.
In a statement, Nestlé India reaffirmed its commitment to regulatory compliance and pledged ongoing collaboration with the FSSAI. Following the announcement, the company’s shares dropped by 1.4% on the Bombay Stock Exchange, closing at ₹1,353.10.
The FSSAI’s actions focus on specific compliance failures, but the broader impact on infant nutrition marketing in India remains uncertain. Regulatory challenges in this area often arise from the tension between consumer protection and industry practices, especially when scientific claims overlap with promotional tactics. The resolution of these cases may shape future labeling and advertising standards for infant foods.
The FSSAI’s scrutiny follows a pattern of increased enforcement in the infant nutrition sector, where marketing claims frequently draw regulatory attention. The authority’s decision to pursue multiple cases against Nestlé India signals a stricter stance on compliance in this sensitive market.