IBFAN calls for mandatory warnings and information on labels and product websites that powdered formulas and human milk fortifiers are not sterile: IBFAN members’ submissions to a 2020 international survey showed that there are still very few countries where manufacturers and distributors must provide mandatory warnings on labels and information that the products are not sterile and may be contaminated by harmful bacteria. IBFAN calls for clear and prominent information on labelling that extra care must be taken in preparation, storage and handling, and must include the lethal decontamination step. IBFAN calls for Cronobacter/Enterobacter and Salmonella infections to become reportable as a mandatory notifiable disease in all countries. The only State in the USA that has mandatory reporting is Minnesota, and this is where the first case of Cronobacter infection was reported in the USA. If there had been no consumer reports then the public would never have known about the dangers of contaminated powdered formulas.

IBFAN emphasises that breastfeeding is the gold standard and protects the health of all infants, especially those in vulnerable situations.

Artificial feeding using breastmilk substitutes and feeding bottles and teats (nipples) is a deviation from this norm. It can involve serious health risks and extra precautions should be taken when preparing, storing and handling feeds and selecting feeding utensils.

Are the bacteria in powdered formulas friendly or unfriendly?

Unfounded claims for beneficial bacteria Baby food companies manufacture and market powdered milk formulas and cereal products for infants and young children. These companiesmake unfounded claims on product labels, stating that their product contains special ingredients which are alleged to improve growth, make digestion easier or protect against infections. Such additives include probiotics, the so-called ‘friendly bacteria’ which are claimed to improve infant health and make the formula ‘even closer to breastmilk’. The heavy promotion of products claiming such benefits for these added probiotics gives some companies a competitive edge over others.Yet these claims are unsubstantiated by scientific evidence, meaning that parents, care-givers and health professionals are misled. Failure to warn about harmful bacteria At the same time, the baby food companies fail to state on product labels that powdered infant formulas and cereals may also contain harmful bacteria – the definitely ‘unfriendly bacteria’. These companies do not inform parents and health professionals that powdered formulas are not sterile and can also contain pathogenic bacteria, such as Salmonella species or Cronobacter/Enterobacter sakazakii. These bacteria can be introduced during the manufacturing process and may cause severe invasive infections which can be fatal or cause life-long disability. All those responsible for the care and healthy development of infants and young children must be warned of this risk. World Health Organization guidance informs – and warns For this reason, in 2007 the World Health Organization, WHO, producedGuidelines for the safe preparation, storage and handling of powdered infant formula. These Guidelines state in the very first sentence “Powdered infant formula (PIF) has been associated with serious illness and death in infants due to infections with Enterobactersakazakii. During production, powdered infant formula can become contaminated with harmful bacteria such as Enterobactersakazakii and Salmonella enterica. This is because, using current manufacturing technology, it is not feasible to produce sterile PIF.” In these Guidelines, WHO insists that “Users of PIF are made aware that powdered infant formula is not a sterile product and maybe contaminated with pathogens that can cause serious illness. Correct preparation and handling reduces the risk of illness.” This risk of contamination can thus have serious consequences for the survival and health of infants and young children.

WHO’s “New Safety Advice”, also issued in 2007, carries the clear and direct message:

“Powdered infant formula is not sterile.  It may contain bacteria that can cause serious illness in infants. By preparing and storing powdered infant formula correctly, you can reduce the risk of illness.”