How safe are infant formulas?
The death of a one-week old formula-fed baby in Belgium

The recent death of a 5-day old boy from meningitis in Belgium raises important questions about the labelling and promotion of breastmilk substitutes and the adequacy of commercial surveillance systems. These issues are currently being discussed at the Codex meeting in Halifax, Nova Scotia, which IBFAN (International Baby Food Action Network) delegates are attending.

The baby in question was born healthy in a hospital in Aalst, Belgium and was fed on Nestlé’s Beba 1 infant formula. Soon after leaving hospital on his 5th day of life (the normal discharge time in Belgium) he became ill and his parents took him during the night to the University Hospital in Gent. Soon after, on the 16th March, he died of meningitis.

The family contacted IBFAN when they realised that the death was caused by Enterobacter Sakazakii, a very resistant bacteria that can live in powdered milk.

In April 2002 a communication about Enterobacter Sakazakii was issued by the US Food and Drug Administration (FDA) stating that a study had found contamination in 14% of tins of formula (see the letter on the FDA website). It mentioned a "Belgian case" dating back to 1998 that had resulted in a number of ill children and 2 infant deaths. The warning suggests that powdered formula should not be used for feeding infants in neo-natal units, but notes that healthy infants have also become ill. The warning also states:

"As background information for health professionals, FDA wants to point out that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile."

On 2nd May, nearly seven weeks after the infant died, the Federal Agency for Food Safety in Belgium, as a precautionary measure, asked Nestlé Belgium to recall Beba 1 900 gram (codes DEXCPIKA and/or DEXCPIKB, expiry date 02 2003). An advertisement from Nestlé appeared in every newspaper and items also appeared in the evening news on the television channels. One of the newspaper articles cited the anger of the baby’s father at discovering that the parents of the two babies that died in 1998 were never informed of the cause of deaths. In its statements Nestlé claims that the level of contamination is well below the acceptable international standard of 4 bacteria per 100g, and that the product is not sterile. On the 10.30 pm news, Nestlé’s spokesman, Cedric de Prelle, said that “the germs present in the product help with the production of immune factors.”

The batch in question was manufactured by Nestlé Germany Kapeln. Nestlé claims this was distributed only to Belgium and Switzerland, but the product has now also been taken off the market in Luxembourg (although no information has been supplied to consumers there). In previous cases the source of contamination has been notoriously difficult to find and companies have failed to admit the extent of problem and the distribution channels (Note 1).

This case has important implications for the current discussions surrounding labelling, health claims and risk assessment and demonstrates the need for publicly funded, centralised surveillance systems (Note 2). It also illustrates the risks of allowing the promotion and idealisation of artificial feeding which undermine breastfeeding and encourage the unnecessary use of breastmilk substitutes (Note 3). There is clearly an urgent need for better labelling and for health care systems to provide truly independent information to parents. If a low level of contamination can harm health in this way, labels should state that the product is not sterile and may contain bacteria which could grow under certain conditions and cause harm.

IBFAN's legal advisor, Graham Ross, gave the following opinion: "Even if the manufacturers have indeed followed "highest standards", product liability laws still require clear warnings, especially in connection with products, such as formula, over which consumers can be expected to be highly concerned at all levels of risk."

For information contact:

GIFA, Geneva Infant Feeding Association. Tel: +41 22 798 9164

Els Flies, Vereniging Begeleiding en Bevordering van Borstvoeding (VBBB - Belgian IBFAN group). +32 3 2817313 or +32 3 6771318. (Press releases in Dutch and French are available in the 'nieuws' section of http://www.vbbb.be/)

Patti Rundall, Baby Milk Action, 23 St Andrew’s St, Cambridge, CB2 3AX, UK. Tel: +44 (0) 1223 464420 fax: + 44 (0) 1223 464417 Mobile: +44 (0) 7786 523493

Elisabeth Sterken, INFACT Canada, 6 Trinity Square, Toronto, ON, M5G 1B1. Phone +1 (416) 595-9819. Fax +1 (416) 591-9355

Notes to editors

1. In Jan 1997 Milupa/Nutricia was asked by the UK authorities to withdraw its infant formula Milumil from sale following evidence that a number of Milupa-fed infants had been infected with a rare strain of salmonella called salmonella anatum. Milupa issued contradictory and misleading statements, claiming that the problem was unique to the UK, that the link was not really proven and that the British authorities had “reacted over zealously.” In February, French authorities ordered the withdrawal of Lemiel 2. Milupa’s factory in Colmar, France was closed for one week for disinfection but the source of infection was not found (see Nutricia conceals salmonella risks – parents are kept in the dark Baby Milk Action Update 20, Feb 1997). Mr Klaas de Jonge, Director of Nutricia denied that there could be a problem with the factory or that other products could be affected. He suggested that because from January 1997 the company would no longer use milk bought in from French and Dutch farms, the problem was now contained. French authorities and the European Commission admitted that the same source material used for the French and UK milks is also in babymilks on sale in Belgium, Italy and Holland.

2. In 1985, When the Farley’s factory was infected by Salmonella, it took months before the source was identified. Holes in a spray dryer caused intermittent contamination. Salmonella was found in only 4 out of 267 packets of the product. The factory was eventually closed down. (Lancet Oct 17 1987). Speaking at the time, Sir Leslie Turnberg, Chairman of the UK Public Health Laboratory Service (PHLS) commented: “The vital importance of infectious disease surveillance is clear from the global increase in infectious diseases and the looming threat of antibiotic resistance... The effectiveness of the PHLS is beyond question, and the astonishingly swift identification of the cause of the recent outbreak of salmonellosis from powdered baby milk undoubtedly saved many babies from becoming ill.”

3. The Beba brand has been promoted in Belgium through the distribution of free samples of Beba 2 in the health care system. Nestlé has also been exposed for aggressively promoting Beba 2 baby milk in Hungary by sending free samples to new mothers after taking contact details from the birth registery (see Baby Milk Action Campaign for Ethical Marketing action sheet October 1999, which includes scans of the promotional materials).