The Maharashtra Food and Drug Administration (FDA) has issued a statewide compliance order tightening the manufacture, sale, labelling and promotion of infant foods and milk substitutes, citing concerns over breastfeeding practices and emerging health risks among children and adolescents as part of the need for stricter enforcement.
The order, issued by Food Safety Commissioner Tukaram Mundhe under Section 30 of the Food Safety and Standards Act, 2006, brings enforcement of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, alongside the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, under a single enforcement mechanism.
The order, which came into force immediately, applies across the supply chain, including manufacturers, brand owners, importers, re-packers, distributors, retailers, pharmacies, hospital suppliers and e-commerce platforms dealing with infant formula, infant milk food, follow-up formula, complementary and traditional infant foods, foods for special medical purposes and feeding bottles.
Among violations flagged by the FDA during inspections and surveys were labels without mandatory breastfeeding notices, age-of-introduction and preparation warnings, as well as products marketed under descriptions such as "baby cereal", "health mix", "stage food" and "nutrition powder" to evade prescribed standards.
Under the order, packages must prominently display the notice, "IMPORTANT NOTICE – MOTHER'S MILK IS BEST FOR YOUR BABY", on the front. Pictures of infants or women are prohibited, as are descriptions such as "humanised", "maternalised", "complete food" and "health food". Complementary foods must also state that they should be introduced only after six months.
The FDA said the stricter enforcement also comes against the backdrop of health and breastfeeding trends highlighted through National Family Health Survey (NFHS)-6 data. According to data cited while explaining the measure, only 55.8% of mothers initiate breastfeeding within the first hour after birth, falling to 52.8% in urban areas.
Officials also pointed to health indicators among children and adolescents, including data showing 35.1% of those aged 10-19 with high blood pressure and 12.3% classified as prediabetic or diabetic. High triglyceride levels and low HDL cholesterol have also been reported in this age group. The FDA linked these trends to concerns over improper infant and childhood feeding practices and the longer-term burden of non-communicable diseases.
The compliance order imposes a complete prohibition on advertisements, free samples, gifts, coupons, cashback, discount campaigns, influencer promotions and cross-promotions of infant milk substitutes, infant foods and feeding bottles, including on e-commerce marketplaces, social media and messaging applications.
Companies are also barred from providing sponsorship, funding, hospitality, travel or registration expenses, speaker fees, research grants or other benefits to health workers, hospitals, nursing homes, pharmacies or medical associations in connection with conferences, seminars, workshops, continuing medical education programmes, fellowships or research activities.
Responding to questions over promotions in the grey areas of social-media advertising, Mr. Mundhe said responsibility could extend to both the company marketing the product and the person endorsing it if the promotion violates the law.
The FDA has also put in place an online system with time-stamped records of complaints and inspections, which officials said is intended to ensure transparency in enforcement and guard against corruption or extortion during inspections.
Manufacturers, importers and brand owners have been given 30 days to conduct self-audits of their licences, product approvals, BIS coverage, formulations, labels and promotional practices and submit compliance declarations. Designated Officers have 45 days to map establishments and online sellers and begin risk-based inspections, while the first consolidated enforcement report is to be submitted to the Commissioner within 60 days.
Violations can attract penalties of up to ₹10 lakh for misleading advertisements or unlicensed businesses, ₹5 lakh for substandard food and ₹3 lakh for misbranded food. Unsafe food can also lead to prosecution, with imprisonment extending up to life imprisonment where consumption results in death. Licences can additionally be suspended or cancelled.
Mr. Mundhe, however, distinguished prohibited commercial promotion from legitimate medical advice. The restrictions do not prevent medical practitioners from providing necessary nutritional guidance where a mother is unable to breastfeed for medical reasons or where an infant requires food for specialised medical purposes. The prohibition is aimed at commercial promotion of substitutes rather than medically necessary advice, he said.
The FDA said the broader objective of the enforcement drive is to encourage healthy feeding practices and ensure safe nutrition during the early years of life, which officials described as crucial to children's physical and intellectual development.
"A child under two cannot protect itself," Mr. Mundhe said, adding that enforcement of the IMS Act would now be the responsibility of every Food Safety Officer in Maharashtra and would be undertaken as rigorously as enforcement of the Food Safety and Standards Act.


