Maharashtra FDA Issues Strict Compliance Order for Infant Foods, Formula Milk and Feeding Bottles

The Maharashtra Food and Drug Administration (FDA) has issued a compliance order regulating the production, import, storage, distribution, sale, labelling and promotion of food for infant nutrition. The order has come into immediate effect, FDA Commissioner Tukaram Mundhe said.

Addressing a press conference at the FDA headquarters in Bandra, Mundhe said the order applies to manufacturers, brand owners, importers, repackers, distributors, retailers, pharmacies, hospital suppliers and e-commerce platforms dealing in infant formula, infant milk food, follow-up formula, complementary food for infants, traditional infant food, food for special medical purposes for infants and feeding bottles.

The order has been issued under Section 30 of the Food Safety and Standards Act, 2006. According to Mundhe, it brings together in one document how food safety officers and designated officers will enforce both the Food Safety and Standards Act and the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992, or IMS Act.

Under the IMS Act, food safety officers have powers of entry, search and seizure, while designated officers or food safety officers can file complaints in court as directed by the Commissioner. Violations of the IMS Act can attract imprisonment of up to three years.

FDA cites violations found during inspections

Mundhe said inspections and surveys by the administration had found products being sold under names such as “baby cereal”, “health mix”, “stage food” and “nutrition powder” to avoid prescribed standards.

The FDA also found labels without mandatory information on breastfeeding, the age for starting feeding and preparation warnings.

According to the Commissioner, promotion of formula milk through hospitals, pharmacies, medical conferences, e-commerce discounts, influencers and parenting platforms in violation of the IMS Act was also found. The administration has recently come across collection and online sale of human milk by private institutions.

Mundhe said the new order has been issued in response to these issues.

What the order requires

Every infant food must be manufactured under a valid FSSAI licence specifying the correct product category. Every infant milk substitute, infant food and feeding bottle must also carry the BIS standard mark as required under Section 11 of the IMS Act.

Products must comply throughout their shelf life with the compositional standards prescribed under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020.

Preservatives, added colours and flavouring agents are prohibited. Lactose and glucose polymers should be the preferred carbohydrates. Sucrose or fructose can be added only when necessary and within a limit of 20% of total carbohydrates. Claims such as “no added sugar” or similar claims cannot be made unless they are true and permitted.

Labels must prominently carry the statement: “IMPORTANT NOTICE – MOTHER’S MILK IS BEST FOR YOUR BABY.”

The label must also state that the product should be used only on the advice of a health worker and warn that it is not the sole source of nourishment. Preparation and boiled-water warnings, a feeding chart and, for complementary foods, a statement that these should be introduced only after six months are also required.

Pictures of infants or women and terms such as “humanised”, “maternalised”, “complete food” and “health food” are prohibited.

Advertising, discounts and influencer promotion prohibited

The order does not permit advertising of infant milk substitutes, infant foods or feeding bottles through any medium, including e-commerce marketplaces, social media and messaging applications.

Free samples, gifts, coupons, cashback, discount campaigns, influencer promotions and cross-promotions are also prohibited.

Manufacturers, importers and brand owners cannot provide sponsorship, funding, hospitality, travel, registration or speaker fees, grants or other benefits to health workers, hospitals, nursing homes, pharmacies or medical associations in connection with medical conferences, scientific meetings, seminars, workshops, CME or CPD programmes, fellowships or research activities, either directly or through organisers, societies, trusts or foundations.

Manufacturers, importers and brand owners must maintain batch-wise traceability, complaint and adverse-event systems and recall capability. Any serious adverse event must be reported to the designated officer within 48 hours.

Hospitals, neonatal units, paediatricians and other medical professionals have been asked to report suspected adverse events associated with infant foods to the nearest FDA office. These include suspected food-borne illness, sepsis or meningitis among formula-fed newborns, allergic reactions, foreign matter and illnesses related to preparation.

The FDA will trace the batch, collect samples and coordinate with the Integrated Disease Surveillance Programme in such cases.

Self-audit within 30 days

Sale of non-compliant products and prohibited advertising and promotion must stop immediately.

Manufacturers, importers and brand owners have been directed to complete a self-audit of their licences, product approvals, BIS scope, formulations, labelling and promotional practices within 30 days and submit a compliance declaration to the designated officer.

Designated officers will map every manufacturer, importer, warehouse, distributor, pharmacy, hospital supplier and online seller within 45 days and begin risk-based inspections. The first consolidated enforcement report will be placed before the Commissioner within 60 days.

Non-compliance will attract action under Chapter IX of the Food Safety and Standards Act. The order specifies penalties of up to ₹10 lakh for misleading advertisements or operating without a licence, up to ₹5 lakh for substandard food and up to ₹3 lakh for misbranded food.

Unsafe food can lead to prosecution, with punishment extending to life imprisonment where death occurs. Action under the IMS Act can include seizure, confiscation and prosecution, while licences can also be suspended or cancelled.

Advisory for parents

The FDA has advised parents to buy infant food only in sealed packages carrying an FSSAI licence number and BIS standard mark.

Parents should read preparation instructions, use boiled and cooled water, discard leftover feed and consult a health worker before starting any infant milk substitute.

Complaints regarding food quality or malpractices can be made on the toll-free number 1800222365 or through the Food & Drug Grievance Portal at https://complaints.mahafda.in/.