Maharashtra FDA Tightens Statewide Rules For Infant Formula, Foods, Feeding Bottles

The Maharashtra FDA has put infant formula, infant foods and feeding-bottle businesses under an immediately enforceable statewide compliance regime, with restrictions extending from labels and product descriptions to social-media promotions, e-commerce campaigns and benefits offered to health workers.

Order brings two regulatory frameworks under one enforcement mechanism

The order was issued by Food Safety Commissioner Tukaram Mundhe under Section 30 of the Food Safety and Standards Act, 2006.

It 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 (Foods for Infant Nutrition) Regulations, 2020, under a single enforcement mechanism.

The Maharashtra Food and Drug Administration said the statewide compliance order tightens the manufacture, sale, labelling and promotion of infant foods and milk substitutes.

The FDA cited concerns over breastfeeding practices and emerging health risks among children and adolescents as part of the need for stricter enforcement.

The order came into force immediately and applies across the supply chain.

It covers manufacturers, brand owners, importers, re-packers, distributors, retailers, pharmacies, hospital suppliers and e-commerce platforms dealing with the regulated products.

The covered products include infant formula, infant milk food, follow-up formula, complementary and traditional infant foods, foods for special medical purposes and feeding bottles.

Labels, images and product descriptions face tighter scrutiny

The FDA said inspections and surveys had flagged labels without mandatory breastfeeding notices, age-of-introduction warnings and preparation warnings.

It also flagged 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 on such products.

Descriptions such as “humanised”, “maternalised”, “complete food” and “health food” are also prohibited.

Complementary foods must 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.

The figure falls 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.

The data cited also showed 12.3% of those aged 10-19 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.

Promotions, discounts and influencer advertising barred

The compliance order imposes a complete prohibition on advertisements of infant milk substitutes, infant foods and feeding bottles.

It also prohibits free samples, gifts, coupons, cashback, discount campaigns, influencer promotions and cross-promotions of these products.

The restriction applies to 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.

The same bar applies to hospitals, nursing homes, pharmacies and medical associations.

The prohibited benefits include those connected 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.

Officials said the system is intended to ensure transparency in enforcement and guard against corruption or extortion during inspections.

Compliance timelines set for companies and officers

Manufacturers, importers and brand owners have been given 30 days to conduct self-audits.

The self-audits must cover their licences, product approvals, BIS coverage, formulations, labels and promotional practices.

They must also submit compliance declarations.

Designated Officers have 45 days to map establishments and online sellers and begin risk-based inspections.

The first consolidated enforcement report is to be submitted to the Commissioner within 60 days.

The timelines place obligations on both businesses and enforcement officials under the same statewide drive.

Penalties include fines, prosecution and licence action

Violations can attract penalties of up to ₹10 lakh for misleading advertisements or unlicensed businesses.

Substandard food can attract penalties of ₹5 lakh.

Misbranded food can attract penalties of ₹3 lakh.

Unsafe food can also lead to prosecution.

Imprisonment can extend 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.

They also do not prevent guidance 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.

FDA says objective is safe early nutrition

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.

Officials described the early years of life as crucial to children’s physical and intellectual development.

“A child under two cannot protect itself,” Mr. Mundhe said.

He added that enforcement of the IMS Act would now be the responsibility of every Food Safety Officer in Maharashtra.

He said enforcement of the IMS Act would be undertaken as rigorously as enforcement of the Food Safety and Standards Act.

The order was published on September 30, 2026 at 07:35 am IST.

Source: The Hindu