FSSAI Files Cases Over Nestlé India Infant Nutrition Claims

• The FSSAI has initiated three legal adjudication cases against Nestlé India over promotional claims and a sub-standard Biotin sample in its infant nutrition products.
• Specific products under scrutiny include Nestlé NAN EXCELLA PRO Stage 1 and LACTOGEN PRO 1, with claims like "5 HMOs" and "Whey Protein" being flagged.
• FSSAI alleges violations of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, and Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992.
• Nestlé India asserts its products are fully compliant, stating their labels were previously approved by an FSSAI expert committee and are scientifically supported.
• A separate laboratory analysis confirmed a Nestlé India follow-up formula was sub-standard in Biotin content, failing to meet prescribed requirements.

This development underscores the FSSAI's stringent enforcement of regulations concerning infant nutrition product claims and quality in India.

The Food Safety and Standards Authority of India (FSSAI) has initiated legal proceedings against Nestlé India, filing three adjudication cases concerning alleged non-compliance related to its infant nutrition products. This regulatory action stems from an examination of promotional claims associated with two specific products, NAN EXCELLA PRO Stage 1 and LACTOGEN PRO 1, as well as a separate finding regarding a sub-standard Biotin sample in another follow-up formula. The FSSAI's move signals a heightened focus on the adherence to stringent infant formula regulations in India.

Nestlé India has publicly responded to these allegations, asserting that its NAN EXCELLA PRO and LACTOGEN PRO products, along with their associated labels, are fully compliant with all applicable food safety standards. A company spokesperson indicated that an expert committee constituted by the FSSAI had previously approved these products and their labeling. The company further stated that it has provided a comprehensive response to the regulator's notice, maintaining that the statements on its labels are factual and supported by scientific literature.

The FSSAI's investigation specifically targeted promotional materials found on e-commerce platforms. For NAN LACTOGEN PRO Stage 1, the regulator flagged claims pertaining to "5 HMOs" (human milk oligosaccharides) and "Whey Protein." Similarly, LACTOGEN PRO 1 carried a claim describing its "Whey Protein" as easy to digest, which also drew regulatory attention. After seeking clarifications from Nestlé India and reviewing the company's submission, the FSSAI concluded that these promotional claims contravened Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. This particular provision is designed to restrict promotional claims or materials that could artificially boost the sale of infant foods, thereby safeguarding infant feeding choices from commercial influence.

Beyond the promotional claims, the FSSAI also invoked Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992, a foundational statute that explicitly prohibits the advertisement and promotion of infant milk substitutes and infant foods. This reflects a long-standing public health concern regarding the marketing practices for such sensitive products. In a distinct finding, a sample of a follow-up formula manufactured by Nestlé India was determined to be sub-standard in its Biotin content following laboratory analysis. This deficiency was subsequently corroborated by a referral laboratory, confirming that the product did not meet the prescribed Biotin content infant formula standards, which are essential micronutrient specifications under Indian food safety norms. These combined findings led to the filing of three separate adjudication cases, one for each product under scrutiny.

Despite the legal action, Nestlé India maintains its commitment to regulatory compliance and intends to continue its engagement with the food safety regulator. The company spokesperson reiterated that all products adhere to regulations, including all norms and label declarations as per applicable laws. They emphasized that Nestlé India will work closely with and support the FSSAI in its efforts to enhance consumer awareness regarding infant nutrition. The company's defense centers on the prior approval of its product labels by an FSSAI expert committee and the scientific backing for its label statements.

This development underscores the FSSAI's stringent enforcement of regulations concerning infant nutrition product claims and quality in India. The action highlights the regulator's commitment to upholding the integrity of the Food Safety and Standards (Infant Nutrition) Regulations 2020 and ensuring Infant Milk Substitutes Act 1992 compliance. The scrutiny over specific claims like "5 HMOs" and "Whey Protein," alongside the focus on Biotin content infant formula standards, signals a comprehensive approach to India food advertising claims enforcement. This situation serves as a critical reminder for all manufacturers in the infant food sector to meticulously review their product labeling, promotional materials, and quality control processes to align with the rigorous standards set by Indian authorities.

This development signals FSSAI's stringent enforcement of regulations concerning infant nutrition product claims and quality in India. Legal and compliance teams in the food sector, particularly those dealing with infant foods, should review their product labeling, promotional materials, and quality control processes to ensure strict adherence to the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 and the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992, to mitigate similar regulatory risks.

Source: Original reporting via industry sources