Baby formula 'carelines' endangering health with poor advice, spot monitoring finds Press release 20 November 2007 Baby food companies go to great lengths to persuade parents in the UK to call their telephone 'carelines' for infant care information, but spot-monitoring conducted by Baby Milk Action found that advice on mixing up formula contradicts the guidance from the Food Standards Agency (FSA) introduced 2 years ago. This latest finding adds weight to a call by the Baby Feeding Law Group (a coalition of health workers and mothers support groups) for the prohibition of company carelines, in line with World Health Assembly marketing requirements, in favour of independent sources of information. The BFLG recently submitted a report Protecting breastfeeding - Protecting babies fed on formula to a government consultation on strengthening the UK formula marketing law. Guidance to parents from the FSA advises that powdered formula is not sterile and that it should be reconstituted with water above 70 Deg. C to kill any possible contamination, such as Enterobacter Sakazakii (which has led to deaths from meningitis, though these are rare) and Salmonella. No company is providing this information clearly to parents and most contradict it. Hipp's nutritionist told Baby Milk Action's mystery caller: "no-one does it at 70 Deg. C" and said that "we certainly have no problems with bacteria". Hipp is the only company that warns on labels that powdered formula is not sterile, but it advises using water at 50-60 Deg. C (see our press release: New UK formula labels lack correct information - calls for better warnings and instructions). Cow & Gate suggested boiling water in advance and storing it: "That stays fresh without refrigetation for 24 hours. Take from the bottle and mix." Aptamil said: "People can make it at room temperature." Aptamil labels give no temperature advice and say to let water cool for 30 minutes (FSA advice is 'no more than 30 minutes'). The Aptamil advisor said: "The reason we say 30 minutes is that is the optimum time. It is a health and safety issue, we don't want people scalding their hands." This ignores the fact that parents are capable of making a cup of tea with water close to boiling point. Farley's said to let the water cool for 30 minutes, because "it mixes better". SMA was the only company to come close to the FSA advice of using water above 70 Deg. C, saying: "We tend to say 70 Degrees. These are new Department of Health Guidelines. It can destroy any bacteria that may be in the powder." It did not admit that powdered formula is at risk of intrinsic contamination, however, stating: "No formula is sterile if it is exposed to the air." The SMA advisor, like others, when asked to explain about health claims on its formula labels used these to idealize the formula. When asked how SMA could be the closest to breastmilk when others made the same claim, the advisor asserted: "Ours is balanced. It is closest." Aptamil claimed its formula contained: "soluble fibres found in breastmilk". Cow & Gate boasted of prebiotics which "are in breastmilk". Farely's claimed its added LCPs "helps develop their brain in their first few months". The risk from contamination came to public prominence when a 5-day-old child, Natan Geerinck, died from meningitis in Belgium in 2002, linked to Enterobacter Sakazakii contamination in Nestlé’s Beba formula. In October 2007 a Belgian judge rejected a legal action brought by Natan’s parents against staff at the hospital and Nestlé. Nestlé had not provided warnings on labels about the known risks of contamination and the need to prepare the product with water that is greater than 70 Deg. C, but it had complied with legislation. In the UK health advocates are concerned that without a legal requirement to bring guidance into line with that of the Food Standards Agency and the World Health Organisation companies will continue to provide misleading advice with impunity. Mike Brady, Campaigns and Networking Coordinator at Baby Milk Action, said: "I had an array of products in front of me and wanted to see if by calling the 'careline' numbers given on the labels I would be able to understand their claims better and learn how to reduce the risks of possible contamination. Having heard each advisor claim their formula is the best I am no better off. If I was a new parent and followed the 'careline' advice on mixing up formula I could find myself in the horrendous situation of the parents in Belgium who thought they were following best practice, unaware of the risks well-known to the company." In October 2007 the Philippines Supreme Court rejected an industry challenge to Department of Health regulations, which included a requirement for warnings on labels. The ruling stated: "[The regulation] merely adds a fair warning about the likelihood of pathogenic microorganisms being present in infant formula and other related products when these are prepared and used inappropriately...The [industry’s] Petitioner’s counsel has admitted during the hearing on June 19 2007 that formula milk is prone to contaminations and there is as yet no technology that allows production of powdered infant formula that eliminates all forms of contamination.” UNICEF UK Baby Friendly produces leaflets in a variety of languages explaining how to prepare formula. 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." 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." 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.