FSSAI cracks down on Nestle, Zydus for unsubstantiated immunity claims on infant formula

The Food Safety and Standards Authority of India (FSSAI) issued show-cause notices to Nestle India and Zydus Wellness in October 2026, directing both companies to explain why regulatory action should not be taken under the Food Safety and Standards Act, 2006 for health claims the regulator considers misleading or scientifically unsubstantiated.

The notices, reported by ET Healthworld on 22 October 2026, cover products sold to parents of infants and young children, a segment where marketing language carries outsized influence because buyers are making decisions for people who cannot advocate for themselves.

What changed

FSSAI's action targets two distinct product lines and a separate social media enforcement thread.

For Nestle India, the regulator flagged two infant formula products: Lactogen Pro 1 Powder and Nan Excella Pro Stage 1. The specific claim under scrutiny is "5 HMOs helps support normal immune system." HMOs, or human milk oligosaccharides, are prebiotic carbohydrates found naturally in breast milk. Nestle has added synthesised versions to these formulas and built marketing around them.

FSSAI's objection is that the phrasing implies the product is suitable for supporting immunity in relation to a specific physiological condition, which crosses into territory that Indian food law reserves for claims that have been explicitly permitted. FSSAI regulations prohibit claims relating to the prevention, alleviation, or treatment of diseases or physiological conditions unless those claims appear on an approved list. Immunity support, framed the way Nestle has framed it, does not appear to have that clearance.

The regulator also questioned Nestle's claim that the product "contains whey protein, which is a part of milk protein that is easy to digest," and asked for scientific substantiation. This is a softer claim than the HMO immunity language, but FSSAI's position is that even comparative digestibility statements need documented evidence behind them.

For Zydus Wellness (part of the Zydus Lifesciences group), the notice concerns Complan, the decades-old powdered nutrition drink marketed to children. FSSAI asked for scientific justification for three claims: "grow taller faster, clinically proven 2X growth," "supports concentration and memory," and "pro immunity + 34 vital nutrients." The "clinically proven 2X growth" language is the most aggressive of the three. A claim of that specificity requires a randomised controlled trial conducted on the target population, with results that actually show the stated magnitude of effect. FSSAI has not publicly confirmed whether Zydus submitted any such data, and the company has not issued a public statement as of the date of this article.

In a separate but related action, FSSAI issued notices to influencer Ira Fathima, Abbott Healthcare (maker of Similac Advance 1), Nestle India, Nutricia International (maker of Aptamil Premium 1), and Mead Johnson Nutrition India (maker of Enfamil A+ Stage 1) over an Instagram reel that ranked the "Top 5" infant formula products. The reel listed Nan-Pro 1, Aptamil Premium 1, Similac Advance 1, Enfamil A+ Stage 1, and Dexolac 1. Promoting infant milk substitutes through social media influencers is restricted under the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, commonly called the IMS Act. The regulator's move signals that it is watching influencer channels, not just brand-owned advertising.

What buyers and cooks should do

Parents choosing infant formula are not in the same position as someone picking a snack at a supermarket. Formula is a medical-adjacent product, and the claims printed on tins carry weight precisely because parents trust them. Here is what the current situation means practically.

The HMO claim on Lactogen Pro 1 and Nan Excella Pro Stage 1 has not been proven false by FSSAI. The regulator has asked Nestle to substantiate it. There is peer-reviewed research showing that certain HMOs, particularly 2'-fucosyllactose, influence gut microbiota composition in infants, but the evidence on immune outcomes in healthy, term infants is still being debated in clinical literature. The gap between "some HMOs affect gut bacteria" and "5 HMOs support your child's immune system" is where FSSAI is pushing back.

For Complan, the "2X growth" claim has been a fixture of the brand's advertising for years. Zydus has not publicly released the clinical trial data behind it. Until FSSAI publishes its findings or Zydus releases the underlying study, parents should treat that number as unverified marketing language.

If you are currently using any of the flagged products, there is no safety recall and FSSAI has not said the products are unsafe to consume. The notices are about labelling and advertising compliance, not product composition. That said, a claim that cannot be substantiated to a regulator's satisfaction is a claim you should not be making purchasing decisions based on.

For infant formula specifically, the World Health Organization recommends exclusive breastfeeding for the first six months. When formula is medically necessary or chosen by the family, the decision is best made with a paediatrician who can look at the infant's specific needs rather than at a tin's marketing copy.

FSSAI has not yet published the full text of either notice or set a public deadline for the companies' responses. The regulator's track record on follow-through with show-cause notices is mixed: some cases result in product label changes, others in fines, and some are resolved quietly after the company submits documentation. Whether Nestle and Zydus will be required to change their packaging or pull specific claims from advertising is not yet known.