New Delhi: The Food Safety and Standards Authority of India (FSSAI) has initiated three separate legal cases against Nestle India over alleged non-compliance involving three infant nutrition products. The cases pertain to promotional claims made for two products and inadequate biotin levels found in a sample of a follow-up formula.
The action involves NAN Excella Pro Stage 1, Lactogen Pro 1, and a follow-up formula, according to an adjudication sanction shared by the food regulator Friday. FSSAI said it examined the products and promotional material available on e-commerce platforms before initiating the proceedings.
Nestle India, however, rejected FSSAI’s charge of non-compliance.
Responding to FSSAI’s action, Nestle India’s spokesperson said, “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. 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.”
“We confirm to adherence of all regulations including all norms and label declarations as per applicable laws. We will continue to work closely and support FSSAI in its efforts towards consumer awareness,” the spokesperson added.
For NAN Excella Pro Stage 1, the regulator questioned claims about “5 HMOs” and “Whey Protein”. For Lactogen Pro 1, it questioned the claim that its whey protein was “easy to digest”.
Infant formula is a manufactured milk-based substitute for breast milk, while follow-up formula is intended for older infants after the first months of life. HMOs, or human milk oligosaccharides, are complex sugars naturally found in breast milk that are added to some infant formula products.
The action comes as Indian authorities have stepped up scrutiny of food safety, adulteration and potentially misleading food advertisements in recent months, with regulators and state authorities taking action against companies over product quality and marketing claims.
The food regulator said both products, NAN Excella Pro Stage 1 and Lactogen Pro 1, were found to be in contravention of Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which restricts promotional material intended to increase the saleability of infant foods.
The regulator also cited Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, which prohibits advertising and promotion of infant milk substitutes and certain infant foods.
Concerns over the marketing of breast-milk substitutes predate India’s regulations by decades.
In the 1970s, health campaigners accused formula manufacturers of aggressively promoting their products in developing countries, including through free or low-cost supplies and promotion involving health workers. The controversy around such practices, including a boycott of Nestle products launched in the US in 1977, eventually fed into broader international action.
In 1981, the World Health Assembly adopted the WHO International Code of Marketing of Breast-milk Substitutes, which sought to limit commercial promotion of breast-milk substitutes and prevent marketing from influencing infant-feeding decisions.
India subsequently enacted the 1992 law to regulate the production, supply and distribution of infant milk substitutes, feeding bottles and infant foods and to protect and promote breastfeeding. The law places restrictions on advertising, promotion and inducements related to these products.
Against this backdrop, FSSAI said a sample of a follow-up formula manufactured by Nestle India was found to be substandard for biotin content during laboratory analysis. Biotin is a B vitamin needed in small amounts for normal growth and metabolism.
The sample was subsequently referred for re-analysis, and the referral laboratory also found it non-conforming with the prescribed biotin requirement under the 2020 regulations.
The proceedings do not amount to a ban on the products or establish that all batches are unsafe. Nestle India has not yet publicly responded to the legal action.
Following this, Nestle India’s shares fell as much as 2.8 percent Friday, Reuters reported.
Previously, Nestle India faced regulatory scrutiny before in 2015 when its Maggi instant noodles were at the centre of a major food-safety controversy after tests ordered by Indian authorities found lead levels above permissible limits. Nestle disputed the findings and challenged the ban imposed by FSSAI. The Bombay High Court later ordered fresh testing, and Maggi returned to the Indian market after the required tests.
(Edited by Amrtansh Arora)
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