FDA to act against surrogate, misleading ads for infant foods across hospitals, seminars, conferences

Invoking existing provisions, FDA Commissioner Tukaram Mundhe issued a comprehensive compliance order on Tuesday

Mumbai: After taking on restaurants, clubs, and gymkhanas, the FDA has now shifted its focus to taking action against food for infant nutrition, such as infant formula and milk foods.

FDA to act against surrogate, misleading ads for infant foods across hospitals, seminars, conferences

Invoking existing provisions, FDA Commissioner Tukaram Mundhe issued a comprehensive compliance order on Tuesday. He warned all stakeholders involved in the manufacturing, distribution, and endorsement of infant formula, milk foods, and feeding bottles against engaging in direct or indirect advertising or endorsements.

Citing sections of the Infant Nutrition Regulations, 2020, and the Infant Milk Substitutes Act, 1992, Mundhe warned of a complete ban on advertising and promotional practices, such as distributing infant foods as free samples, gifts, coupons, or cashbacks. He also cautioned against surrogate or misleading advertisements by influencers.

Allied sponsorship of events, hospitality, speaker fees, or grants provided to doctors, hospitals, or medical associations for conferences and research by infant food manufacturers to promote their products are strictly prohibited and will henceforth be monitored by the FDA.

Hospital pediatricians have been asked to report suspected adverse events related to infant foods—including suspected foodborne illness, sepsis, or meningitis in formula-fed newborns, as well as allergic reactions, foreign matter, and preparation-related illnesses—to the FDA. The authority will then trace the batch, draw samples, and coordinate with the Integrated Disease Surveillance Programme.

“While doctors can prescribe infant formula, they cannot suggest brands. Nor can hospitals be used for surrogate advertising of any kind. The hospital ecosystem is meant to encourage breastfeeding,” Mundhe said.

Going forward, all infant foods must feature a label stating that “Mother’s milk is best for your baby,” along with a declaration that the product should be used only on the advice of a health worker. The label must also carry a warning that the product is not the sole source of nutrition for infants and should be introduced only after six months.

Mundhe clarified that any stock lacking these mandatory warnings will no longer be permitted to be stocked or sold in the market, noting that “these laws have been in force since 1992.”

Citing findings from the National Family Health Survey (NFHS), he pointed out that breastfeeding—a critical component of immunity development in children—has dropped to a mere 52% in urban India, leaving children vulnerable. Additionally, parents increasingly rely on packaging labels and the guidance of health workers, he noted.

Film Stars Respond to FDA Notice

Mundhe stated on Tuesday that Shah Rukh Khan, Ajay Devgn, and Tiger Shroff—who were issued notices for participating in the surrogate promotion of banned pan masala and tobacco-related products—have responded to the FDA. Two of the actors have also attended hearings before FDA officials, though Mundhe declined to reveal their names. He emphasized that actors and influencers are accountable for the products they endorse and cannot claim ignorance.