Maharashtra FDA bans formula milk ads, influencer promotions, mandates breastfeeding warning

The Maharashtra Food and Drug Administration (FDA) on Tuesday issued a comprehensive compliance order tightening rules governing formula milk and other infant nutrition products, mandating prominent breastfeeding notices on packages and prohibiting advertising, free samples, discounts and influencer promotions.

The order, which came into effect immediately, applies to manufacturers, brand owners, importers, repackers, distributors, retailers, pharmacies, hospital suppliers and e-commerce platforms dealing with infant milk food, follow-up formula, complementary and traditional baby foods, foods for special medical purposes and feeding bottles.

Warning made mandatory

FDA Commissioner Tukaram Mundhe said every package must prominently display the words “IMPORTANT NOTICE” and “MOTHER’S MILK IS BEST FOR YOUR BABY” on the front. Labels must also carry feeding instructions, while complementary foods must state that they should be introduced only after the child completes six months.

Pictures of infants or women on such products have been prohibited. The order also bars descriptions such as “humanised”, “maternalised”, “complete food” and “health food”.

The FDA said infants and children below two years were particularly vulnerable consumers because they could not make their own food choices and parents depended heavily on labels and advice from healthcare professionals.

Ads and influencers barred

Advertising infant milk substitutes, infant foods and feeding bottles has been prohibited across media, including e-commerce marketplaces, social-media platforms and messaging applications. Free samples, gifts, coupons, cashback schemes, discount campaigns, influencer promotions and cross-promotions are also barred.

“No person or company, hospital, doctor or influencer will be permitted to promote formula milk in violation of law,” Mundhe said.

Companies have also been prohibited from offering sponsorships, hospitality, travel, registration or speaker fees, grants or other benefits to doctors, hospitals, nursing homes, pharmacies or medical associations in connection with conferences, seminars, continuing medical education programmes or research.

Fines up to Rs 10 lakh

Misleading advertisements and operating without the required licence could attract fines of up to Rs 10 lakh, while substandard food could invite a penalty of up to Rs 5 lakh. Misbranding could attract a fine of up to Rs 3 lakh.

Infant foods must be manufactured under valid FSSAI licences covering the appropriate product categories, while applicable products must also carry the prescribed BIS certification.

The FDA has asked manufacturers, importers and brand owners to undertake self-audits covering licences, product approvals, certification, formulations, labels and promotional practices.

Colours, preservatives barred

The order prohibits preservatives, added colours and flavouring substances in infant foods. Lactose and glucose polymers are to be preferred as carbohydrates, while sucrose may be used only when necessary and within the prescribed limit of 20 per cent of total carbohydrates.

False “no added sugar” claims have also been prohibited. Manufacturers, importers and brand owners will have to maintain batch-wise traceability, complaint and adverse-event monitoring systems and the capability to recall products when required.

Adverse events reporting

Hospitals, neonatal units and paediatricians have been directed to report suspected adverse events involving infants receiving formula or other covered products. Manufacturers will be required to report serious adverse events within 48 hours.

The reporting framework covers suspected foodborne illness, allergic reactions, foreign matter and illnesses potentially linked to the preparation or consumption of infant foods.

FDA steps up action

The infant-nutrition order comes as the Maharashtra FDA intensifies enforcement across the state. In a separate operation, the regulator seized refined soyabean oil stock valued at Rs 3.51 crore at Khamgaon in Buldhana district during action against M/s Am Oels Pvt Ltd.

The agency also seized banned gutkha following a vehicle chase from Palghar towards Kasara Ghat on the Mumbai-Nashik route. The actions form part of a broader enforcement drive involving food safety, licensing and prohibited products across Maharashtra.