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Subject:
From:
Janice Reynolds <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Thu, 16 Dec 2004 16:28:16 -0600
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(Sorry for the length of this message, but didn't know ehere to edit since its not on-line.  INFACT Canada just sent this out today.  This relates to the lawsuit we've been discussing.
Janice Reynolds)


The infant formula industries are refusing to label their products to warn that powdered infant formulas are not sterile and may contain harmful microorganisms that can cause illness or death in premature, low-birth weight, ill babies, new born and young infants. 
We have also asked Health Canada to require labelling and to put out an advisory to parents/consumers regarding this serious hazard, but so far the health advisory has gone to hospitals and NICUs.

Elisabeth Sterken
INFACT Canada

Two babies die in France following possible contamination by Enterobacter Sakazakii

Following on from the European Food Safety Agency's (EFSA)  opinion  in November about  contamination of infant formula by Enterobacter sakazakii, Salmonella and other pathogens,  two more babies have died  as a result of  contamination. It is  not yet clear whether the cause of death was the contamination in the formula itself or the way the formula was prepared, but the cases clearly call for more to be done to alert people to the known  risks of powdered infant formula.  (see Paris press article below)

The rapid alert system of the EU, found  Enterobacter sakazakii  in Dutch formula  Pregestimil,  manufactured  by the US company Mead Johnson and marketed in France. Three batches of  Pregestimil have been recalled in France.

EFSA - the scientific advisory body  which assesses risk and advises the  European Commission -  has advised that no babies under 4 weeks should be fed with powdered formula and that those not breastfed should receive only ready-to-feed sterile formula.  The World Health Organisation came to similar conclusions  as EFSA in its  expert meeting  convened earlier this year.  

Baby Milk Action and its partners in the global network  IBFAN, and many NGOs throughout the  UK and Europe are calling on the European Commission (which is revising EU legislation on the marketing of breastmilk substitutes)  to  protect infant health by banning the promotion of breastmilk substitutes and ensuring that  labels of powdered  infant formula carry effective warnings that the product is not sterile and may be contaminated and that this warning is linked to the need for much safer preparation instructions.      IBFAN was first alerted to this emerging public health  problem in March 2002 when a 5 day old Belgian baby died because of contaminated formula. 

At present the Commission is  pushing  a whole series of health claims which will serve only to idealise the products, undermine breastfeeding and expand the EU baby food market.  

For more information contact:  INFACT Canada Elisabeth Sterken 416 595-9819 

See Rapid Alert System for Food and Feed (RASFF) Week 50  http://europa.eu.int/comm/food/food/rapidalert/reports/week50-2004_en.pdf  page 2, last line of the attached document.)
 See  WHO reports:  http://www.who.int/foodsafety/micro/jemra/assessment/esakazakii/en/
See EFSA opinion: http://www.efsa.eu.int/press_room/press_release/696_en.html
See  INFACT Canada website at http:/www.infactcanada.ca 
See Dutch information: http://www.vwa.nl/php/news.php?news_id=382 and  http://www.voedingscentrum.nl/mirakel/pageViewer.jsp?id=4868

Here is a rough translation of the Dutch information: 
Food and Safety Autorities (VWA) investigate into samples of infant
Formula  [Dec 13 2004]
Yesterday the VWA received a message from France about a recall of the powdered milk Pregestimil, a product that is sold only through pharmacies in the Netherlands. In France two infants died, as a result of the rare bacteria Enterobacter sakazakii. In France three batches of  S401719, S401420 en S402077 were recalled. It has not yet been determined for sure if the death of the infants was the result of contamination of the product or a wrong way of preparation. The VWA has started an investigation into the formula Pregestimil. The results of this research will be known this week.

Infections with Enterobacter sakazakii are rare and occur in weakened infants or premature babies, usually following intake of prepared infant formula contaminated with the bacteria. The bactaria can develop if the product is stored too warm (warmer than 4°C).

Recently the European Food Safety Authority and the VWA formulated advices on the risks tied to the presence of this bacteria.

More information:
http://www.vwa.nl/php/page_sub.php?structure_id=109 (dossier Enterobacter S.)
http://www.efsa.eu.int/press_room/press_release/696_en.html
http://www.voedingscentrum.nl/


PARIS (AFP)
11 December 2004 17h54

Recall of lots of Pregestimil after the death of two infants

Three lots of Pregestimil, a food for infants, have been recalled from sale after two infants died of a rare infection that has been
cought by at least for newborns in France in the last five weeks, the Direction Générale de la Santé (DGS) [a French health authority, HH]
has indicated on Saturday.

In a communication, the institute "l'Institut de veille sanitaire" speficied that at least one of the two babies died following the
infection of the bacteria Enterobacter sakazakii in a hospital setting in the Paris region.
 
Infections by Enterobacter sakazakii are rare and occur mainly in newborns or fragile premature babies, most often following intake of
contaminated powdered formula, the DGS specified.

"In these 4 cases of infection, 3 have in common that they consumed Pregestimil, a formula for infants of the laboratories of  Mead Johnson
Nutritionals, the fourth had been in direct contact with one of the ill infants', the communciation of the DGS continues.

This formula is mainly indicated in cases of allergies for cows milk proteďns, as well as in the case of intolerance for lactose or saccharose, and in case of acute diarrhea of premature babies or infants under the age of 3 months.

"Today, the bacteriological results of the suspected lots are not known yet. However, as a measure of precaution, the laboratory
recalls the following lots of  Pregestimil: n° S401719 manufactured in May 2004, n° S401420 manufactured in June 2004 and n° S402077
manufactured in July 2004", the communication specifies.

Boxes corresponding to these lot numbers must not be used. Families are advised to consult their peadiatrician or other health care
professional who is treating their infant who will advise them to either continue to use the same product of a different lot or a
replacement product, adds the DGS.

"In case of fever with digestive troubles or other worries with an infant that has consumed Pregestimil, it is necessary to consult a
doctor and inform this person of the use of this formula", concludes the communcation that gives a green number that has been put into
place by the laboratory: 0811.88.40.40.

The  official French publication of December 10th:
http://www.sante.gouv.fr/htm/actu/31_041210.htm




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