The recent death of a five-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, issues recently discussed at the Codex meeting in Halifax, Nova Scotia, and attended by IBFAN (International Baby Food Action Network) delegates
The baby was born healthy in a hospital in Aalst, Belgium, and was fed on Nestlé's Beba 1 infant formula. Soon after leaving hospital at age five days (the normal discharge time in Belgium), he became ill; his parents took him to the University Hospital in Ghent. Later, on 16 March 2002, he died of meningitis. The family contacted IBFAN when they realised that the death was due to Enterobacter sakazakii, a highly resistant bacteria that can live in powdered milk.
In April, a communication on E. sakazakii was issued by the US Food and Drug Administration (FDA), stating that it had found contamination in 14 per cent of tins of formula tested. It mentioned a Belgian case, dating back to 1998, that had resulted in a number of ill children and two infant deaths. The warning suggests that powdered formula should not be used for feeding infants in neonatal 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 heattreated 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.'
Nearly seven weeks later on 2 May, 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 advert from Nestlé appeared in every newspaper, and items also appeared in the evening news on television.
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 the deaths. In its statements, Nestlé claims that the level of contamination is well below the acceptable international standard of 4 bacteria per 100 g, and that the product is not sterile. On the 10:30 evening 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 the problem and the distribution channels.
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 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
There is clearly an urgent need for better labelling and for healthcare 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 that 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 more information, contact Baby Milk Action (23 St Andrew's Street, Cambridge CB2 3AX; tel: 01223 464 420). You can also access the Baby Milk Action website at: www.babymilkaction.org or the International Baby Food Action Network at: www.ibfan.org.
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