FSSAI Cracks Down on Nestlé, Zydus Wellness Over Unsubstantiated Health Claims

The Food Safety and Standards Authority of India (FSSAI) issued formal notices to Nestlé India and Zydus Wellness Products Ltd in October 2026, demanding scientific evidence to support health and nutrition claims appearing on product labels and in advertising material. Three products are under scrutiny: Nestlé's Lactogen Pro 1 Powder, Nestlé's Nan Excella Pro Stage 1, and Zydus Wellness's Complan. The notices ask both companies to explain why regulatory action should not be initiated against them under the Food Safety and Standards Act, 2006.

Nestlé India is a subsidiary of Swiss food giant Nestlé S.A. Zydus Wellness Products Ltd is a subsidiary of Zydus Lifesciences, the Ahmedabad-based pharmaceutical and consumer health conglomerate. Both companies confirmed receipt of the notices and said they had submitted responses to FSSAI.

What FSSAI flagged

For Lactogen Pro 1 Powder, FSSAI took issue with the claim that the product "contains Whey Protein, which is a part of milk protein that is easy to digest." The regulator has not publicly stated that the claim is false. It has asked Nestlé to produce the scientific documentation that substantiates it. That distinction matters: FSSAI's concern is about proof of claim, not necessarily the claim itself.

The Nan Excella Pro Stage 1 notice raises a more pointed objection. The product carries the claim "5 HMOs helps support normal immune system," where HMOs refers to human milk oligosaccharides, a class of prebiotic carbohydrates found in breast milk. FSSAI said this claim implies the product is suitable for supporting the immune system, which brings it into conflict with provisions that restrict disease-related or physiological-condition claims unless those claims are expressly permitted under applicable regulations. The same "contains whey protein" claim that appears on Lactogen Pro 1 also appears on Nan Excella Pro Stage 1, and FSSAI flagged it on this product too.

For Complan, FSSAI's specific objection has not been detailed in the public notice. Zydus Wellness said it had submitted a "detailed clarification" and maintained that Complan's label statements are "factual and supported by scientific evidence."

Nestlé India's spokesperson told Mint that the company had already submitted a detailed response, noting that FSSAI's October post "reiterates the points raised in its earlier post of 18 September regarding product labels."

Why this matters for Indian consumers

Infant formula and children's nutrition drinks occupy a peculiar space in Indian retail. Parents buying Lactogen Pro 1 or Nan Excella Pro Stage 1 are making decisions for newborns and infants, a population that cannot self-advocate. The claim that a product "supports normal immune system" function carries real weight in that purchase decision, and the Food Safety and Standards Act, 2006 exists precisely to prevent claims from doing marketing work that clinical evidence has not earned.

HMOs are a legitimate area of nutritional science. A 2023 review published in Nutrients found that specific HMOs in infant formula can influence gut microbiota composition, though the authors noted that translating microbiota changes into measurable immune outcomes in healthy infants remains an active area of research. FSSAI's concern appears to be that the label collapses that nuance into a flat immune-support claim, which the regulations do not permit without express authorisation.

For Complan, the product has a long history of advertising claims in India, including height and growth promises that have drawn scrutiny before. FSSAI has not published the specific claim it is challenging this time, so it is not possible to evaluate Zydus Wellness's assertion that its statements are scientifically backed.

This action is part of a broader pattern. FSSAI has been issuing notices to major food and nutrition brands through 2026, including earlier notices to Nestlé India and Hindustan Unilever over separate products. The regulator has also warned nutraceutical firms over labelling violations and flagged Horlicks over a "happy birth weight" claim. The pattern suggests the regulator is running a systematic review of health and nutrition claims across the category, not responding to individual complaints.

What buyers should do

For parents choosing infant formula, the regulatory notice does not mean these products are unsafe. FSSAI has not recalled Lactogen Pro 1 or Nan Excella Pro Stage 1. What the notice does mean is that at least two claims on those labels have not yet been verified to the regulator's satisfaction.

When reading any nutrition label, treat immune-support and digestibility claims as marketing language until you can find the underlying study. For infant formula specifically, the World Health Organization recommends exclusive breastfeeding for the first six months. Where formula is necessary, a paediatrician is a better guide to product selection than label copy.

For Complan, the product is marketed primarily at children aged two and above. FSSAI has not specified which claim is under review, so the practical step is to ask your paediatrician whether the product's nutritional profile fits your child's needs, independent of whatever the packaging says.

More broadly, FSSAI's Food Safety Connect portal allows consumers to file complaints about misleading labels. If you see a claim on a food product that seems implausible, that is the formal channel. The regulator appears to be using it.