Ruling in Belgium : deaths from contaminated formula are to be accepted

News arrives from Belgium that a family has lost its legal action against Nestlé and the hospital that put their new-born child onto infant formula that turned out to be contaminated with bacteria. The effect of the ruling is to suggest that deaths from intrinsic contamination of formula, which are rare, are to be expected and accepted.

The couple's son became ill with meningitis and died at 5 days old. This was linked to Enterobacter Sakazakii contamination in Nestlé Beba infant formula, prompting a recall. See the International Baby Food Action (IBFAN)'s press release from 10 May 2002.

This death and others in France prompted action at the World Health Assembly. IBFAN called for improved labelling to warn of the risks and how to reduce them. This call was reflected in the Resolution adopted shortly afterwards (WHA 55.25) and more explicitely in 2005 (WHA 58.32) after the World Health Organisation had held an expert meeting.

We are now working for improved labelling standards at the Codex Alimentarius Commission, whose standards are seen to carry greater weight than World Health Assembly Resolutions in that the World Trade Organisation looks to them if evaluating whether national measures are proportionate should there be a trade dispute. The baby food industry is at Codex in force, attempting to weaken measures that could impact on its profits. We have called for greater transparency on conflicts of interest in the past, much to the annoyance of the Chair (see Update 37 for example).

The issue of contamination of powdered infant formula has been known about for decades and the Food and Drug Administration in the United States quotes a study that shows it is worryingly common, found in 14% of tins surveyed. See my earlier blog on Enterobacter Sakazakii for links to references.

In 2005 the UK Food Standards Agency (FSA) issued guidance for parents saying to use water of at least 70 Deg. C to make up the formula to kill any pathogens. As we reported in Update 38 the Northern Ireland Department of Health and the Welsh Assembly Government issued booklets giving this information and stating clearly that formula is not sterile and may contain harmful bacteria.

As we have exposed, companies have still not brought their labels into line, despite issuing new labels this year in response to a crackdown on the use of illegal health claims. See our press release:

The UK Government is revising the Infant Formula and Follow-on Formula Regulations and last week we submitted a report on behalf of the Baby Feeding Law Group (BFLG) which calls for a statutory requirement for warnings and instructions on labels to be in line with official guidance. The Food Standards Agency had proposed a voluntary agreement. As the companies didn't bring their labels into line when they had the chance, it is clearly not sensible to rely on their good intentions.

The BFLG report refers to a spot check of company carelines we conducted. This found that advisors are giving advice to parents that contradicts the independent, expert guidance from the Food Standards Agency and World Health Organisation. We have heard claims on carelines that powdered formula is sterile until opened and to make up formula using water at room temperature, which has been pre-boiled. This is dangerous information. The fact is the water needs to be added to the formula at high temperature to kill any bacteria. We will issue a full report on the monitoring in due course.

My view is that it should be a criminal offence for companies to deny parents critically important information about reducing risks from formula on the label.

I understand the Judge in the Belgium case cleared the hospital of negligence as it was not the source of the infection and cleared Nestlé as it had complied with the relevant legislation. No matter that Nestlé was well aware that powdered infant formula is not sterile and may contain harmful bacteria, which it did not warn about on its labels. The parents are in my view justifiably aggrieved at only learning this information after their child died.

If more infants die from contaminated formula prepared using the advice from the carelines or labels a UK judge may well rule company had complied with the law. This is why we think it is so dangerous for the FSA to pursue a voluntary agreement with the industry about warnings and instructions instead of setting out in the legislation that they must comply with official guidance to parents.

Fortunately deaths from contaminated formula are rare, though it is unknown how much the higher incidence of gastroenteritis and other illness is due to contamination as this has not been monitored.

Personally I think the idea that deaths from contaminated formula are to be expected and accepted, as the Belgian ruling suggests, is not the correct response to the tragedies that have occurred. Action must be taken to ensure parents have the information they need to reduce risks.

If you agree please support our work and sign up to receive information from our making formula use safer campaign.

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