New UK formula labels lack correct information - calls for better warnings and instructions Press release 10 August 2007 'Breast is best' is a well-known slogan. It is a living substance providing protection against infection as well as nutrition. Less well known amongst the public is the risk coming from possible contamination of formula. This is contamination coming after pasteurisation. Powdered infant formula is not sterile. Despite all companies in the UK relaunching formula labels this year following a crack down on illegal health claims, only one company has put this important fact on the label, but the instructions it gives on mixing up the formula are not those called for by the government and health experts. Mixing powdered infant formula with water at a temperature of no less than 70 °C dramatically reduces the risk. Baby Milk Action is calling for stronger controls on baby food companies so mothers who use formula are fully informed to make formula feeding safer. Mike Brady, Campaigns and Networking Coordinator at Baby Milk Action, said: "Infant formula could be viewed as a nutritional medicine. Companies should remove their idealizing claims and cartoon animals from labels and give parents the information they need to make formula use as safe as possible. This demonstrates once again the need for stronger legislation and for independent advice for parents. While all companies fail to give the facts about formula risks and clear instructions, it is particularly concerning that Hipp directly contradicts government advice. We have asked Trading Standards to take action so warnings and instructions are improved as quickly as possible." The risk from contamination came to public prominence with the death of a 5-day-old child in Belgium in 2002 as a result of meningitis linked to contamination of Nestlé formula with Enterobacter Sakazakii. That case is currently in court. Such serious cases are fortunately very rare. It is not known how much the greater incidence of other illnesses such as gastro entiritis is due to bacteria in the formula. In the UK it was estimated in 1995 that the NHS spends £35 million treating the gastro entiritis attributable to formula feeding. The fact that such contamination occurs has been known about for far longer than the 2002 case. This and other deaths in France, prompted the World Health Organisation to hold expert meetings produce guidelines. The Food Standard Agency has had its version of these on its website since the end of 2005. Key amongst these is to include a step in the preparation of powdered infant formula that will kill any bacteria such as Enterobacter Sakazakii or Salmonella. The guidance to parents is to use water at more than 70 Deg. C. UNICEF produces leaflets in a variety of languages explaining how to do this practically. The leaflets look like the instructions on the side of a formula pack. Step 1 states: "Boil some fresh tap water and let it cool for a few minutes. (It should still be more than 70 Deg. C so don't leave it for more than half an hour)...." The WHO guidelines explain why this is important: "preparation of Powdered Infant Formula with water at a temperature of no less than 70 °C dramatically reduces the risk." Hipp is one of the companies that has just launched onto the market. Hipp had to change its labels after the Food Standards Agency reminded companies of the provisions of the Infant Formula and Follow on Formula Regulations 1995. Claims such as "Formulated to be nutritionally close to breastmilk" used on Hipp labels do not comply with legislation. Having the chance to update its labels Hipp has added a notice that: "Powdered baby milk formulas are not sterile and reconstituted feeds are at risk of infection [sic]" Then, however, its instructions state: "Boil water and leave to stand until temperature reaches 50 - 60 Deg. C (30 - 40 minutes)". This contradicts the expert guidance. (Click here for a larger version). None of the main companies, which have also issued new labels this year, give the information as clearly and as accurately as UNICEF and the Food Standards Agency. None other than Hipp state that powdered formula is not sterile and they do not give temperature information. Rather than warning not to let water cool for more than half an hour, as in the Food Standard Agency, UNICEF and Department of Health Guidance, most labels simply say 'leave to cool for 30 minutes'. Research by the Food Standards Agency has found that while initially mothers are concerned to learn that formula is not sterile, there is then agreement on the importance of information: "Overall, as powdered infant formula may pose a potential risk to babies, parents and healthcare professionals agreed that parents should be informed that it is non-sterile, so that they can are able to make an informed decision about its use and preparation." Baby Milk Action and partners in the Baby Feeding Law Group and Breastfeeding Manifesto coalition are calling for improved labelling of formula. This is an ideal opportunity as the law is being revised. See: http://www.babyfeedinglawgroup.org.uk/advocacy/uklaw0707.html Interestingly, but perhaps not surprisingly, the guidance that some of the formula companies have added to their labels already is to throw away unused feed. Indeed, Hipp did so 18 months ago and attempted to gain publicity for 'leading the way' soon after the FSA guidance for parents first came out. But it was selective then too in what it implemented. See our press release from 4 January 2006: Hipp endangers infants with misleading information on formula preparation. Commenting on Hipp’s advice at that time, Dr Jorgen Schlundt, Director of WHO’s Department of Food Safety, Zoonoses and Foodborne Diseases, said: “Although any effort to eliminate the practice of keeping left-over, re-constituted formula at dangerous temperatures for later use should be commended, I am surprised that they seem to be dealing with less than half of the problem, and have not dealt with the bacteria that may be present in the powder itself.” Baby Milk Action has already asked Trading Standards to investigate this matter. There is a parliamentary campaign calling for authorities to take action over the continued use of idealizing claims not permitted by the law. See press release 20 July 2007. For more detailed commentary on the labels see Baby Milk Action Campaigns Coordinator's blog. Contacts Mike Brady, Campaigns and Networking Coordinator, Baby Milk Action 07986 736179. Notes for Editors: UK Guidance on preparing infant formula 29 November 2005 www.food.gov.uk/news/newsarchive/2005/nov/ infantformulastatementnov05  Baby Milk Action is the UK member of the global network, IBFAN – The International Baby Food Action Network , www.ibfan.org , the Baby Feeding Law Group and the Breastfeeding Manifesto coalition. IBFAN's monitoring around the world has found systematic violations of the International Code and Resolutions by companies well-known in the UK. It has exposed Hipp's aggressive marketing, particularly in Eastern Europe, in the past. See http://www.ibfan.org/hipp/ and Breaking the Rules. Also see the codewatch section of this site. Belgian baby death sparks safety questions archive.babymilkaction.org/update/update31.html Cases of E. Sakazakii infection have been reported from Israel, USA, Iceland, Belgium and many other countries. For example in Iceland and Germany healthy full term infants died from infection caused by E. sakazakii in the tin. In Bangkok, bacterial contamination of bottle milk from 500 infants attending the Out-Patients Clinic showed bacterial contamination in 91.8% of samples. Bacteria included Klebsiella sp. (56%); Enterobacter sp. (41.3%) etc. In the USA in 2001: Portagen (Mead Johnson) contaminated with E. sakazakii caused infection in newborns and 2002: Wyeth recalled store brand powdered milk contaminated by E. sakazakii. Alerts were sent to doctors in the Gulf that E. sakazakii is linked to diseases with a high mortality rate. In October 2004 infection by Enterobacter Saazakii in premature babies in France led to the death of 2 babies and disease and infection in 13 others. On May 3, 2005 the French authorities announced an epidemic of Salmonellosis in 123 babies fed on the Picot, Gallia/Blédina and Blédilait/Blédina brands (note 4) . In this outbreak the incriminated product was exported to 11 countries and territories. French Institut de Veille Sanitaire, Point InVS 3 mai 2005 www.invs.sante.fr/presse/2005/le_point_sur/salmonella_agona_040505/ EFSA Panel advises on how to avoid microbiological risks in infant formulae – at home and in hospital  18 November 2004 www.efsa.eu.int/press_room/press_release/696_en.html http://www.efsa.eu.int/science/biohaz/biohaz_opinions/691_en.html ”Temperature is the main factor responsible for the multiplication of the microorganism in the reconstituted formula. Rhodehamel (1992) found that temperature in many home refrigerators ranged from 7 to 10 ºC. Harris (1989),reported that 20% of the home refrigerators surveyed were between 5 and 10 ºC, while van Garde and Woodburn (1987) found that refrigerator temperatures in 21% of households surveyed were above 10 ºC. Daniels (1991) reported that more than 25% of home refrigerators were above 7.2 ºC and almost 10% above 10 ºC. A study by Audits International (2000) on temperatures of food products at different stages of storage, including the home, showed that 18% of samples had a temperature between 5.5 and 6.6 ºC and the 3% had a temperature between 8.8 and 10 ºC. Those temperatures would allow growth of E. sakazakii if present in the reconstituted infant formula. The temperatures in domestic refrigerators from eight surveys were overviewed by James (2003). The average temperature in consumer refrigerators was calculated to be around 6-7 ºC. However, from the minimum and maximum temperatures there was a large variation between individual refrigerators. Around 30 % of the refrigerators were at average temperatures above 7 ºC.” WHA RESOLUTION  58.32 Infant and young child nutrition. www.ibfan.org/english/resource/who/whares5832.html Para 1 (3) Urges member States to “to ensure that clinicians and other health-care personnel, community health workers and families, parents and other caregivers, particularly of infants at high risk, are provided with enough information and training by health-care providers, in a timely manner on the preparation, use and handling of powdered infant formula in order to minimize health hazards; are informed that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; and, where applicable, that this information is conveyed through an explicit warning on packaging; International Food Safety Authorities Network, INFOSAN, Information Note No. 1/2005, Enterobacter sakazakii : "The inclusion of a lethal step, e.g. the use of hot water at 70°-90°C during the reconstitution of powder as well as a decrease in the holding time before feeding as well as the feeding time itself would effectively reduce the existing risk". For more information see: http://www.ibfan.org/english/news/press/press25may05.htm http://www.ibfan.org/english/news/press/press18may05.htm Stating consequences in warnings ELM ('elaboration likelihood model') developed by Petty & Cacioppo 1986. When highly involved, one is more persuaded by good arguments than by the credibility of the source. • Mark R Lehto, 'Designing warning signs and warning labels: Part 1 - Guidelines for the Practitioner', Int'l J of Industrial Ergonomics 10:105-113, 1992 Content guidelines, #2 Focus on reminding of a routine action or of the consequences of what you do. #12 “Where judgment-based, consider stating hazard and the value of compliance, using high-credibility sources.” • Venema, Anita and Zieverink HJ. 1992. Product information effectiveness: Implications for the design and standardization of product information. The Hague: Inst for Consumer Research. • Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA, 2001 http://www.fda.gov/cdrh/ohip/guidance/1128.html " There are four elements generally recognized by the courts and research [...] 4. the consequences, specifying the serious adverse events, potential safety hazards and limitations in device use that result if users do not follow instructions. The purpose is to give them a clear idea of the risk, which is likely to increase compliance. Hazard alert research has shown that this element has a significant effect on readers. If the consequences are not included, the alert is likely to be less effective." Michael S. Wogalter. Factors Influencing the Effectiveness of Warnings. 2005 http://www.electromark.com/help/research/research_reg_specs.asp " [...] One of the main motivators in a warning message is the consequence statement, in which the potential negative outcomes that can result from noncompliance are described. In order for this component to be effective, the consequence information should be presented using explicit language (Laughery et al., 1993b). That is, users should be told exactly (specifically) what can result if they do not comply. In addition to providing the user with a better understanding of the nature of the potential hazard, explicitness provides the user with a proper appreciation of the severity of potential injury. As described earlier in the attitudes/beliefs stage, perceptions of how severe an injury might be (more than, for example, likelihood information or personal familiarity with the equipment) to be a major factor driving people’s precautionary actions (Wogalter and Barlow, 1990; Wogalter et al., 1991; Young et al., 1990, 1992). Accidents are relatively low probability events, and combined with the fact that people have difficulty discriminating or comprehending very low probabilities, it makes some sense that people do not pay much attention to likelihoods of injury. Warnings that describe the severity of the consequences explicitly have the power to motivate people to comply with the accompanying warning instructions because the hazard-related consequences are usually outcomes that people want to avoid." • David M Dejoy 'Motivation' , in Wogalter, DeJoy and Laughery 'Warning and Risk communication,' Taylor & Francis, 1999 especially p. 228 See also: the cost-benefit perspective on warnings in Viscusi et al 1986 and Viscusi 1994: Vlscusl, W.K., MAGAT, W.A., and HUBER, J. (1986) Informational regulation of consumer health risks: an empirical evaluation of hazard warnings. Rand Journal of Economics, 17, 351-365. Vlscusl, W.K. (1994) Efficacy of labeling of foods and pharmaceuticals. Annual Review of Public Health, 15, 325-343.