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The Food Safety and Standards Authority of India (FSSAI) has initiated three separate adjudication cases against Nestle India over alleged regulatory non-compliance involving three infant nutrition products, the regulator said on Friday, September 18.
The action relates to promotional claims made for NAN Excella Pro Stage 1 and Lactogen Pro 1, as well as a laboratory finding concerning the biotin content of a sample of Nestle’s follow-up formula.
According to a The Hindu report, FSSAI examined the products and promotional material available on e-commerce platforms. In the case of NAN Excella Pro Stage 1, the regulator flagged claims relating to “5 HMOs” (human milk oligosaccharides) and “Whey Protein”. For Lactogen Pro 1, it raised concerns over a claim describing “Whey Protein” as “easy to digest”.
FSSAI said it had sought clarifications from Nestle India regarding the claims before initiating legal action.
The regulator found the two products to be in contravention of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The provision restricts promotional claims or material intended to increase the saleability of infant foods.
FSSAI also cited Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which prohibits the advertisement and promotion of infant milk substitutes and infant foods covered by the law.
Meanwhile, Nestle India has said its products are fully compliant with applicable regulations and that the labels of NAN Excella Pro and Lactogen Pro had been approved by an FSSAI expert committee. “Our products are fully compliant with all the applicable regulations. The said products (i.e., NAN Excella Pro & Lactogen Pro) and their labels were approved by the expert committee of FSSAI,” a Nestle India spokesperson said.
“In response to the notice, we have again submitted our detailed response to the authorities regarding statements appearing on the label, which are factual in nature, and supported by scientific literature,” the spokesperson added.
The company also said it adhered to applicable regulations, including norms and label declarations, and would continue to work with FSSAI on consumer awareness.
Separately, FSSAI found a sample of a follow-up formula manufactured by Nestle India to be substandard with respect to its biotin content during laboratory analysis.
The sample was subsequently sent for re-analysis. The referral laboratory also found that the sample did not conform to the prescribed biotin requirement under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.
The applicable standards prescribe a biotin content of 7.5 to 50 micrograms for the relevant infant food. Biotin, also known as vitamin B7, is a water-soluble vitamin involved in several metabolic processes.
“In view of the above contraventions, three separate adjudication cases have been filed against M/s Nestle India Limited in respect of the three products,” FSSAI said.
The proceedings are at the regulatory stage. The initiation of the cases does not by itself establish a final violation or indicate that a penalty has already been imposed.
The action comes amid regulatory restrictions on the promotion and marketing of infant nutrition products. India’s IMS Act, enacted in 1992, places restrictions on the advertisement and promotion of infant milk substitutes and certain infant foods, with the stated objective of regulating their production, supply and distribution.