Maharashtra FDA Tightens Infant Food Rules; ‘Mother’s Milk Is Best’ Notice Made Mandatory

Mumbai, September 29, 2026: Buying infant formula or other baby food in Maharashtra is set to become more tightly regulated, with the Food and Drug Administration (FDA) ordering immediate compliance with rules on labelling, sale and promotion of infant nutrition products.

The order makes the notice “IMPORTANT NOTICE & MOTHER'S MILK IS BEST FOR YOUR BABY” mandatory on the front of packages and bans discounts, free samples, influencer promotions and other marketing of infant formula.

Order Covers Infant Nutrition Products

Issued on Tuesday by FDA Commissioner Tukaram Mundhe, the order covers infant milk substitutes, infant formula, follow-up formula, complementary and traditional infant foods, special medical-purpose foods for infants and feeding bottles. It applies to manufacturers, importers, distributors, retailers, pharmacies, hospital suppliers and e-commerce platforms.

The action follows FDA inspections that found products being sold under names such as “baby cereal”, “health mix”, “stage food” and “nutrition powder”, allegedly to circumvent prescribed standards.

Officials also flagged products with missing breastfeeding notices, age-of-introduction information and preparation warnings. Promotion of formula milk through hospitals, pharmacies, medical conferences, e-commerce platforms and influencers has also come under the scanner.

The FDA has also flagged the reported collection and online sale of human milk by private entities.

The order brings enforcement of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, together with the Food Safety and Standards Act, 2006, under one mechanism.

Breastfeeding Data Raises Concerns

The need for tighter oversight comes amid gaps in breastfeeding practices. NFHS-6 data shows 53.2% of children under three in Maharashtra were breastfed within one hour of birth, including 51% in urban areas and 54.7% in rural areas.

Exclusive breastfeeding among children under six months was 52.8% in urban and 75.2% in rural Maharashtra. About 96.4% of deliveries were institutional, making hospitals an important point of contact for mothers and newborns.

Marketing Restrictions Tightened

Besides the mandatory breastfeeding notice, labels must carry preparation warnings, feeding instructions and advice to use the product on a health worker’s advice.

Complementary foods must state that they should be introduced only after six months. Pictures of infants or women and terms such as “humanised”, “maternalised”, “complete food” and “health food” are prohibited.

Companies cannot offer advertisements, free samples, gifts, coupons, cashback, discounts or influencer promotions. They are also barred from providing sponsorship, hospitality, travel, registration or speaker fees, grants or other benefits to healthcare professionals or institutions linked to medical conferences or research.

Compliance Checks And Penalties

As per the compliance order, manufacturers must report serious adverse events within 48 hours and complete a compliance self-audit within 30 days. FDA officials will map sellers and begin risk-based inspections within 45 days.

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Violations can lead to seizure, prosecution and suspension or cancellation of licences. Under food safety provisions, penalties can extend to Rs 10 lakh for misleading advertisements or unlicensed business, Rs 5 lakh for sub-standard food and Rs 3 lakh for misbranded food. Violations of the IMS Act can also attract imprisonment of up to three years.

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