No formula ads, free samples or influencer promotions: Maharashtra FDA tightens infant food rules

The Maharashtra Food and Drug Administration (FDA) has issued a comprehensive statewide order tightening the regulation of infant foods and formula, prohibiting their advertising, promotion and putting hospitals, doctors, pharmacies, e-commerce platforms and influencers under greater scrutiny.

The order, issued by Maharashtra Commissioner of Food Safety Tukaram Mundhe, came into force with immediate effect and covers the manufacture, import, storage, distribution, sale, labelling and promotion of infant formula and milk food, follow-up formula, complementary and traditional infant foods, foods for special medical purposes intended for infants and feeding bottles.

The FDA said the order has been issued under the Food Safety and Standards Act, 2006, and brings the provisions of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (IMS Act) into a common enforcement mechanism with food-safety legislation.

Under the order, companies will not be permitted to advertise infant milk substitutes, infant foods or feeding bottles in any medium.

The prohibition extends to free samples, gifts, coupons, cashback schemes, discount campaigns, influencer promotions and cross-promotions, including on e-commerce marketplaces, social media and messaging applications.

Companies have also been prohibited from providing sponsorship, funding, hospitality, travel, registration or speaker fees, grants or other benefits to healthcare workers, hospitals, nursing homes, pharmacies or medical associations in connection with conferences, seminars, workshops, fellowships or research activities, as per the order made available at a press conference held earlier today.

This effectively places promotional relationships between infant-food manufacturers and the healthcare sector under the FDA's scanner.

The FDA has mandated that the front of every package carry the declaration,

“IMPORTANT NOTICE, MOTHER'S MILK IS BEST FOR YOUR BABY.”

Labels must also state that the product should be used only on the advice of a health worker and carry warnings about preparation and the use of boiled water. For complementary foods, packaging must state that they should be introduced only after six months.

The use of pictures of infants or women and terms such as 'humanised', 'maternalised', 'complete food' and 'health food' has also been prohibited.

The administration said its inspections and surveys had found products being sold under descriptions such as 'baby cereal', 'health mix', 'stage food' and 'nutrition powder', allegedly to evade prescribed standards.

The FDA also cited what it described as promotion of formula milk through hospitals, pharmacies, medical conferences, e-commerce discounts, influencers and parenting platforms.

The order comes amid the FDA's stated concern over the collection and online sale of human milk by private entities. It reiterates that commercial sale of human milk is prohibited.

Further, the order stated that infant foods must be manufactured only under a valid FSSAI licence specifying the relevant product category. Infant milk substitutes, infant foods and feeding bottles must carry the required BIS standard mark. The products must comply with the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.

The order prohibits preservatives, added colours and flavours. It says lactose and glucose polymers should be the preferred carbohydrates, while sucrose or fructose may be added only when necessary and within the prescribed limit of 20 per cent of total carbohydrates.

It also prohibits 'no added sugar' or similar claims unless they are true and permitted.

Hospitals, neonatal units, paediatricians and other medical practitioners have also been asked to report suspected adverse events associated with infant foods, including foodborne illness, sepsis or meningitis in formula-fed newborns, allergic reactions, foreign matter and preparation-related illness.

Manufacturers, importers and brand owners have been given 30 days to conduct a self-audit covering licences, product approvals, BIS certification, formulations, labelling and promotional practices and submit a compliance declaration.

Within 45 days, designated officers are required to map manufacturers, importers, warehouses, distributors, pharmacies, hospital suppliers and online sellers and begin risk-based inspections. The first consolidated enforcement report is to be placed before the Commissioner within 60 days.

Non-compliance, as per the order, can attract action under the Food Safety and Standards Act. Unsafe food can lead to prosecution and imprisonment, including imprisonment for life where consumption results in death, according to the FDA order.

The FDA has also directed parents to buy infant food only in sealed packages bearing the FSSAI licence number and BIS standard mark.

“A child under two cannot protect itself. Every package of infant food sold in Maharashtra will carry the notice that mother's milk is best for the baby, and no company, hospital, doctor or influencer will be allowed to promote formula milk in violation of the law,” Mundhe said.