Key Data Summary of Flagged Products and Regulatory Findings
| Product Name | Regulatory Issue Flagged | Specific Law Cited | Current Status |
| NAN Excella Pro Stage 1 | Restricted e-commerce claims on “5 HMOs” and “Whey Protein” | Regulation 4(2) of FSS Regulations 2020 & IMS Act 1992 | Adjudication case filed |
| Lactogen Pro 1 | Restricted claim that whey protein was “easy to digest” | Regulation 4(2) of FSS Regulations 2020 & IMS Act 1992 | Adjudication case filed |
| Nestlé Follow-up Formula | Biotin content non-conforming upon lab re-analysis | Prescribed 7.5–50 µg/100g biotin standard under FSS Regulations 2020 | Adjudication case filed |
What FSSAI Flags Nestlé Infant Products Action Means for Consumers
Selecting infant formula often involves reading long lists of ingredients on product labels or e-commerce pages. India’s food safety regulator, the Food Safety and Standards Authority of India (FSSAI), has initiated legal action against Nestlé India over alleged regulatory non-compliance. The regulator filed three separate adjudication cases focusing on promotional claims and laboratory findings related to biotin content.
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The products examined include NAN Excella Pro Stage 1, Lactogen Pro 1, and a follow-up formula manufactured by Nestlé India. According to FSSAI findings, a sample of the follow-up formula did not meet the prescribed biotin requirement. A Referral Laboratory confirmed the non-compliance after re-analyzing the sample.
Legal action initiated against Nestle India Ltd over several non-compliances pertaining to the FSS Act.
FSSAI remains committed to strengthening the food safety ecosystem through its enforcement actions. #FSSAINotice #FSSAIAction pic.twitter.com/gG1k6noK0X— FSSAI (@fssaiindia) September 18, 2026
Knowing why FSSAI flags Nestlé infant products helps parents make informed choices when purchasing formula. Understanding these regulatory updates ensures caregivers prioritize safety and objective nutritional facts over marketing slogans.
Overview of FSSAI Regulatory Flags and Marketing Violations
| Legislative Act / Regulation | Key Statutory Requirement | Regulatory Objective |
| IMS Act 1992 (Section 3) | Bars direct or indirect advertising of infant milk substitutes | Protects and promotes breastfeeding practices |
| FSS Regulations 2020 (Reg 4(2)) | Restricts promotional claims that boost product saleability | Ensures objective, non-commercial parent guidance |
| FSS Act 2006 (Section 22) | Mandates strict compliance with composition standards | Maintains uniform nutrition across all formula batches |
The three adjudication cases involve distinct issues and should not be treated as a single product-safety finding. FSSAI examined NAN Excella Pro Stage 1 and Lactogen Pro 1, alongside their promotional materials on e-commerce platforms. For NAN Excella Pro Stage 1, the regulator flagged claims referring to “5 HMOs” and “Whey Protein”. For Lactogen Pro 1, concerns were raised over a claim describing whey protein as “easy to digest”.
According to FSSAI, these claims contravened Regulation 4(2) of the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. This provision restricts promotional material intended to increase the saleability of infant foods. The regulator also cited provisions under the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992, which limits advertising.
In response, Nestlé India stated its infant products are fully compliant with Indian regulations. The FMCG major confirmed that its product labels had received prior approval from FSSAI expert committees. Nestlé added that it submitted detailed scientific responses to support its factual label statements.
Laboratory Findings on Biotin Standards in Follow-up Formula
| Nutritional Parameter | FSSAI Regulatory Benchmark | Role in Infant Health |
| Biotin Range per 100g | 7.5 to 50 micrograms (µg) | Supports protein, fat, and carbohydrate metabolism |
| Biotin Range per 100 kcal | 1.6 to 10.6 micrograms (µg) | Promotes healthy nerve function and cellular growth |
| Classification Status | “Substandard” (Non-conforming) | Indicates variance from prescribed legal limits |
In a separate matter, a sample of Nestlé follow-up formula was found substandard for biotin content during testing. The sample went for re-analysis, and the referral laboratory confirmed non-compliance with the prescribed requirement. Biotin, also known as vitamin B7, is a water-soluble vitamin that helps the body process carbohydrates, fats, and proteins.
Under FSSAI standards, follow-up formula must contain 7.5 to 50 micrograms (µg) of biotin per 100 grams of product. This equals 1.6 to 10.6 µg per 100 kcal. While the exact measured amount was not publicly disclosed, the term “substandard” means the measured biotin content did not meet the regulatory range. It does not indicate that the product was toxic or directly caused biotin deficiency.
Important Guidelines for Parents Choosing Baby Formula
The FSSAI legal action involves adjudication proceedings over alleged non-compliance. The initiation of a case does not mean that every batch is unsafe or that the products have been banned. FSSAI flags Nestlé infant products to enforce strict compositional rules and keep marketing transparent.
Parents should avoid making feeding decisions based only on marketing claims about added ingredients or digestibility. Infant formula choices should match the baby’s age and specific nutritional needs. Any change in formula, especially for babies with feeding difficulties, is best discussed with a qualified pediatrician.
(Disclaimer: This news article is based on information reported by media outlets and regulatory findings available at publication. Parents should consult a pediatrician for individual feeding advice and concerns.)