FSSAI filed three cases against Nestlé India for illegal promotional claims on infant formula products and a Biotin deficiency in a follow-up formula sample. Nestlé says it is fully compliant.
FSSAI has filed three adjudication cases against Nestlé India (a subsidiary of Nestlé S.A.) after finding that two infant formula products carried promotional claims that Indian law explicitly prohibits, and that a third product, a follow-up formula, failed laboratory testing for Biotin content.
The Food Safety and Standards Authority of India examined NAN EXCELLA PRO Stage 1 and LACTOGEN PRO 1 after reviewing product labels and promotional material listed on e-commerce platforms. The regulator found that NAN EXCELLA PRO Stage 1 carried claims about "5 HMOs" (human milk oligosaccharides) and "Whey Protein," while LACTOGEN PRO 1 stated that its Whey Protein was "easy to digest." FSSAI concluded that both products contravened Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, which bars promotional claims or material designed to increase the sale of infant foods. The regulator also cited Section 3 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 (IMS Act), which prohibits the advertisement and promotion of infant foods outright.
In a separate action, a sample of a Nestlé India follow-up formula was sent for laboratory analysis and found sub-standard with respect to Biotin content. A referral laboratory confirmed the finding: the sample did not meet the prescribed Biotin requirement under applicable standards.
Nestlé India responded on 19 September 2026, saying its products are "fully compliant with all applicable regulations." A company spokesperson told news agency ANI that NAN EXCELLA PRO and LACTOGEN PRO, along with their labels, had been approved by an FSSAI expert committee. The company said the label statements are "factual in nature and supported by scientific literature" and that it had submitted a detailed response to the regulator.
What changed, and why it matters
The IMS Act has been on the books since 1992, and the 2020 infant nutrition regulations tightened the framework further. What this action signals is that FSSAI is now actively scanning e-commerce listings, not just physical retail shelves, for non-compliant promotional material. That is a meaningful shift in enforcement scope.
The specific claims at issue are worth understanding. Human milk oligosaccharides (HMOs) are prebiotic carbohydrates found naturally in breast milk. Infant formula manufacturers have begun adding synthetic HMOs and promoting their presence as a selling point. Under Regulation 4(2) of the 2020 rules, any claim, whether about ingredients, nutrients, or digestibility, that is designed to promote the sale of an infant food is prohibited. The regulation does not require FSSAI to prove the claim is false; the prohibition applies regardless of whether the claim is scientifically accurate.
Nestlé's argument that the claims are "factual and supported by scientific literature" may be accurate in a narrow sense, but it does not address the regulatory question, which is whether making those claims on an infant formula label or in e-commerce listings constitutes prohibited promotion. That distinction matters for any brand operating in this category.
The Biotin shortfall in the follow-up formula is a separate concern. Biotin (Vitamin B7) is a water-soluble vitamin that supports fatty acid metabolism and is particularly important in early childhood. The prescribed minimum levels in Indian infant nutrition standards exist because deficiency at this stage can affect neurological development. A referral laboratory confirming the sub-standard finding means the result survived a second round of testing, which is the standard process before adjudication proceeds.
FSSAI has not yet published the full adjudication schedule or the specific penalty amounts being sought. The adjudication process under the Food Safety and Standards Act, 2006 can result in financial penalties and, in more serious cases, product recalls or licence suspension. None of those outcomes has been announced at this stage.
What buyers and parents should do
If you currently use NAN EXCELLA PRO or LACTOGEN PRO, FSSAI has not issued a recall notice for either product as of 22 September 2026. The adjudication cases relate to labelling and promotional claims, not to a finding that the products are unsafe to consume. The Biotin sub-standard finding applies to a follow-up formula sample; FSSAI has not named the specific product or batch publicly.
For parents choosing infant formula, the IMS Act prohibition on promotion exists precisely because marketing pressure can interfere with breastfeeding decisions. When a label or product page highlights HMOs, whey protein digestibility, or similar attributes, that is promotional language, not a neutral nutrition declaration, regardless of whether the underlying science is sound.
When comparing formula products, look at the mandatory nutrient declaration panel rather than front-of-pack claims. For follow-up formulas, Biotin should be listed; the FSSAI-prescribed range for infant formula and follow-up formula is specified in the 2020 regulations, and any compliant product must meet it batch by batch.
If you want to track this case, FSSAI publishes adjudication orders on its official portal at fssai.gov.in. The orders are typically uploaded after the adjudicating officer issues a decision, which can take several months from the date of filing.
Nestlé India has said it will "continue to work closely and support FSSAI." Whether the adjudication panels accept the company's expert-committee-approval argument or treat the e-commerce promotional material as a separate violation will determine the outcome. That answer is not available yet.