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THE WORLD HEALTH ORGANIZATION’S INTERNATIONAL CODE OF

MARKETING BREASTMILK SUBSTITUTES:

A SHORT HISTORY

June P. Brady MD, MPH

Clinical Professor

Department of Pediatrics

San Francisco General Hospital

University of California School of Medicine

San Francisco

California

Learning Objectives

After reading this article readers should be able to:

1. Understand the reasons for aggressive marketing techniques of breast milk substitutes in the developing world
2. Know the increased mortality of infants fed breast milk substitutes in the developing world
3. Know the increased morbidity of infants fed breast milk substitutes in the industrialized world
4. List the major resolutions of the International Code
5. Discuss the effect of current violations of the Code on infant health throughout the world

Key words: Breastfeeding, breastmilk substitutes, formula, developing world, infant mortality, infant morbidity

Abbreviations

APA: Ambulatory Pediatric Association

AgDW: Arbeitsgruppe Dritte Weit: Swiss Third World Action Group

DREAM: Drug Resource Enhancement against AIDS and malnutrition

IBFAN: Infant Baby Milk Action

INFACT: Infant Formula Action Coalition

USAID: United States Agency for International Development

UNICEF: United Nations Children’s Fund

WHA: World Health Assembly

WHO: World Health Organization

Introduction

At the 1981 annual business meeting of the Society of Pediatric Research, in San Francisco, the World Health Organization’s International Code of Marketing Breast milk Substitutes (Code) was condemned as unnecessary and irrelevant (1). I remember a neonatologist saying we should be more concerned about US children dying in traffic accidents than infants dying in the Third World. I was too new and too shy to make a rebuttal! The Code was passed on May 18^th 1981 by 118 votes to one (the USA) (2).

The history of the Code over the past 36 years reads like a mystery novel with the unexplained death of a prominent Philippine lawyer and his son (3,4), the abrupt resignation of senior US officials (5), repeated, often devious, efforts to weaken the Code by pharmaceutical companies and frivolous lawsuits by Nestlé (6,7). This article reviews the long and tortuous story of the WHO Code through and the Baby Friendly Hospital Initiative (8) and the HIV pandemic (9) to its current status.

History prior to the Code

In the 19^th century breastfeeding was almost universal but as Nestlé produced “Farine Lactée” in 1843 and Borden developed canned condensed milk in 1865 substitute feeding became possible (10). Breastfeeding rates declined over the next 100 years as women entered the work force and as formula companies began an intense advertising campaign. Although in 1915 68% of US mothers were breastfeeding for at least one month by 1950 the rate had declined to 17% (11). However, in the 1970’s breastfeeding rates began to increase in the industrialized world, particularly among higher socioeconomic groups and, possibly because of renewed interest in the medical benefits At the same time birthrates declined and formula companies (mainly Nestlé) responded by vigorously seeking new markets in the developing world. Nestlé and other pharmaceutical companies gave gifts to health workers and used salesmen and women dressed as “nurses” to provide donations of formula and advice to mothers on the wards and in the clinics (6). As many of the mothers were illiterate and most were poor this resulted in contaminated, diluted formula and a dramatic increase in mortality from malnutrition, diarrhea and pneumonia virtually unknown previously (12,13,14,15)(Table 1).

In 1979 in Kenya Dr Elizabeth Hillman describes taking two Nestlé representatives dressed as “nurses” to the emergency ward at Kenyatta National Hospital in Nairobi so they could see the results of promoting formula to poor women. She relates how they left shocked by the vision of the dying child and the mother leaving with her can of formula (21). Ten years later, when I was working at Kenyatta, I never saw bottles or formula in the hospital.

In Singapore in1939 Dr Cicely Williams decried this aggressive practice in her lecture “Milk is Murder”. She maintained that “misguided propaganda on infant feeding should be punished as the most criminal form of sedition, and those deaths should be regarded as murder”(6).

Not only in the developing world was morbidity and mortality increased but this was also true in the developed world. A number of articles reported an increased rate of diarrhea and respiratory infections and mortality from feeding breastmilk substitutes (22,23,24).

Politically the tide began to change with the 1974 publication of “The Baby Killer” in the UK (16). This was translated in German by a Swiss Third World Action group with the somewhat provocative title of “Nestlé Kills Babies”. Nestlé sued and the authors were found guilty of libel for their title. They were required to pay a minimal fine. The judge stated that Nestlé must “fundamentally rethink” its advertising practices if it wanted to be spared the accusation of immoral and unethical conduct (18). This was followed by a very successful worldwide boycott of Nestlé products. (6,18).

In the USA in 1978, Senator Edward Kennedy, chairman of the subcommittee on Health and Scientific Research, held a hearing on the promotion and use of infant formula in developing countries (18,19). He asked:

“Can a product which requires clean water, good sanitation, adequate family income, and a literate parent to follow printed instructions, be properly and safely used in areas where water is contaminated, sewage runs in the streets, poverty is severe, and illiteracy high?”(18).

The International Code

In 1979 WHO and UNICEF convened a meeting of 150 participants to discuss how they should respond to this crisis of increased morbidity and mortality of formula fed infants. They included representatives from national governments (including the USA), UN agencies, experts on infant feeding, the infant food industry and nongovernmental organizations. Over the next 2 years they drafted a new code to restrict advertising (18,20). The US position was inconsistent. Initially, the delegates maintained they would support recommendations but not regulations (6). However, even when they were changed to recommendations the new Reagan administration wavered stating the Code would conflict with US trade laws although two memoranda from the Justice Department disagreed (25). On May 18^th 1981 the final Code was passed, (Table 2), 118 countries voting for it, three abstaining (Japan, Argentina and South Korea) and the USA casting the sole vote against it. There was an outcry in the US and both houses of Congress passed resolutions condemning the US position (18). Two senior delegates from USAID, Dr Stephen Joseph and Tony Babb, who had had extensive experience in the developing world, immediately resigned in protest (5).

Pediatric reactions. There were differing responses from US pediatricians: four editorials appeared in Pediatrics; three supporting the US position and one opposing it. (2,26,27,28). Charles May insisted: “No substantial, sound, scientific data were ever set forth … to support the claim that marketing practices for infant formulas have actually been a significant factor in the decline in prevalence of breastfeeding in the Third World or anywhere else”(26).(One might cynically observe that May was also involved in an infant nutrition project supported by a formula company which might have influenced his opinion!). Lucey (2) stated “the major causes of infant mortality, poverty and malnutrition cannot be voted away”.

In contrast, the Board of the Ambulatory Pediatric Association opposed the US position endorsing the Code saying “Free speech cannot be used to defend unrestricted marketing of tobacco or drugs or substances thought to be inimical to health….” and “We have the obligation to be concerned about the health of all children in all lands” (28).

Violations of the Code

Following passage of the Code, within 3 years 130 countries had passed legislation to restrict advertising breast milk substitutes to some degree (18). Papua New Guinea, one of the strictest, had already made formula, bottles and nipples available by prescription only (17). However, in spite of repeated reaffirmation of the Code by the World Health Assembly and by the Innocenti Declarations of 1990 and 2005 (29), recent reports have described continued violations throughout the world (30,31,32,33).(Table 3).

In the Philippines, where only 16% of mothers still breastfeed at 4-5 months, one of the lowest rates in the world, the Department of Health attempted to improve this dismal rate by passing Revised Implementing of the Rules and Regulations of the Milk Code (34). These rules restricted advertising and formula donations to mothers. They were fiercely fought by the pharmaceutical companies. Even the US Chamber of Commerce wrote to President Arroyo threatening such rules would jeopardize US investment. The Philippine government responded by issuing a temporary restraining order, which was finally lifted on Oct 9^th 2007 (34). During negotiations with the pharmaceutical companies, the government lawyer, Ballocillo and his son were shot and killed. The murderer has never been found (3,4).

In Laos Bear Brand coffee creamer (a non dairy product consisting of 58% carbohydrate, 10% fat and 3% protein) was widely advertised and sold to mothers. The coffee creamer has the logo of a mother bear holding baby in the breastfeeding position. It costs 80 cents, and was fed to infants by mothers unaware of the dangers (32,33).With repeated pressure by the Lao pediatric community the company finally placed a small red cross on a bottle and warning in Thai, Lao and English “unsuitable for infants”. (Figure 1). Even so 96% of adults questioned thought the product contained milk and 46% thought it suitable for infants. The company finally removed the logo from the product.

By blatantly ignoring the Code, formula advertising continues throughout the developing world (Figure 2) where child mortality and morbidity remain high. In rural areas which lack sanitation and clean water breast milk substitutes are particularly dangerous (35,36,37,38,39). In Brazil, Victora et al (37) found a 25-fold risk of dying from diarrhea in the first 2 months of life in formula fed infants when compared to exclusively breastfed infants. In Peru, Ghana and India mortality was 10 times greater in infants fed breast milk substitutes in the first 6 months of life (38) and the effect was greatest when maternal education was low. Furthermore, even in Botswana, where most households have piped in water a large outbreak of diarrhea resulted in a 50-fold difference in incidence between formula fed versus breast fed infants seen in the emergency room (39). Furthermore of 28 infant deaths, 27 infants were on formula and only one was breastfed (39). In fact Lauer et al (40) estimated that 1.45 million child deaths could be prevented each year by exclusive breastfeeding.

In industrialized countries in spite of clean bottles, clean water, and literate parents both morbidity and mortality in formula fed infants is higher (43,44,45). Furthermore, although advertising is less blatant, pharmaceutical companies still send unsolicited gifts of formula and coupons to pregnant women and give out free discharge packs, with formula samples, all in violation of the Code. This has been clearly shown to result in earlier weaning (46,47,48). As Wright (47) wrote “we paediatricians must learn to recognize the elaborate web woven around us by formula manufacturers”. Of note pharmaceutical companies spend $30 per baby per year on advertising whereas the US Health Department spends 21 cents on promotion of breastfeeding (35).

Baby Friendly Hospital Initiative

Many hospitals are built to make substitute feeding more convenient for the nurses. In attempts to counter this trend UNICEF created the Baby Friendly Hospital Initiative in 1989 (8). Hospitals throughout the world can now be certified as Baby Friendly if they follow 10 guidelines (8). These include initiating breastfeeding within 1 hour of birth, providing 24 hr rooming, training all perinatal staff in the art of breastfeeding and refusing free formula. When I first went to the San Francisco General Hospital in 1966 only 3-4% of mothers were breastfeeding. In 2007 it became the only Baby Friendly Hospital in San Francisco and currently 93% of mothers leave the hospital breastfeeding. Other hospitals which would like to be Baby Friendly find their administrations unwilling to forgo the donations of free formula which includes mandatory discharge packs for all mothers!

Mother to child transmission of HIV

In 1985 when breastmilk was found to transmit HIV supplemental feeding for all infants of HIV positive mothers was recommended by WHO. (9). The formula companies responded by promoting the dangers of breastfeeding and providing free formula in the developing world (49). However, in the first six months of life mortality from diarrhea and pneumonia exceeded mortality from HIV (31). Furthermore, recent studies have clearly shown that exclusive breast-feeding for 6 months is superior. (41). When exclusive breastfeeding was combined with highly active antiretroviral therapy for the mother and prophylaxis for the baby transmission rates were 0.8% for breastfeeding versus 1.8% for those on formula, without continued prophylaxis (42). Some physicians still insist that free formula can be made “safe” in developing countries (50). However, supplies may become unavailable, sterile techniques inadequate and high mortality may occur with outbreaks of diarrhea (35,39,51).

Summary

The WHO Code of marketing breastmilk substitutes rose out of an alarming increase in advertising and use of substitute feeding in the developing world associated with a dramatic increase in malnutrition, diarrhea and child mortality. The Code attempted to prohibit such advertising, including free gifts to mothers and essentially, bribery of poorly paid health workers. In some ways it had been very successful, in others it has been weakened over the years by the inexhaustible resources of the Pharmaceutical industry. There is still a need to teach all health workers the dangers of breast milk substitutes. Currently, 140 countries have passed some legislation supporting the Code. In the USA companies have made a few voluntary concessions, but we have still not endorsed the Code and no legal actions have been taken, possibly because they might conflict with US “restraint of trade”.

References

1. WHO/UNICEF. International Code of Marketing Breast-milk substitutes. WHO Chronicle 1981;35:112-117

2. Lucey JF. Does a vote of 118 to 1 mean the USA was wrong? Pediatrics 198;68:431

3. Palmer G. The Politics of Breast feeding. Pinter & Martin. London. 2009 p292

4. Srour L. Breastfeeding and infant formulas: Review of: America puts profits above babies’ lives by G Monblot and Milking the formula by J Moorhead: The Guardian Weekly June 15^th 2007. Winter Newsletter AAP Section on International Child Health 2008; p3-4

5. Brozen N. Two US Aides Resign over Baby-Formula Vote. New York Times 1981 May 21^st

6. Palmer G. The Politics of Breast feeding. Pinter & Martin. London. 2009 p230-258

7. Academy wins infant–formula lawsuit. AAP News. 1995;11:1-26

8. Naylor A. Baby Friendly Hospital Initiative: Protecting, promoting and supporting breastfeeding in the twenty-first century. Pediatr Clin N Amer 2001;48:475-483

9. Humphrey JH. The risks of not breastfeeding. J Acquir Immune Defic Syndr 2010;53:

1-4

10. Palmer G. The Politics of Breastfeeding. Pinter & Martin. London. 2009 p206

11. Hendershot GE. Trends in breast-feeding. Pediatrics 1984;Suppl 74:591-614

12. Jelliffe DB. Commerciogenic malnutrition? Nutr Rev 1972;30:199-205

13. Hunter I. The papers of Cicely Williams (1893-1992) in the Contemporary Medical Archives Centre at the Wellcome Institute. Soc Hist Med 1996;9:109-116

14. Plank SJ, Milanisi ML. Infant feeding and infant mortality in rural Chile. Bull World Health Organ 1973;48:203-210

15. Clavano NR. Mode of feeding and its effect on infant mortality and morbidity. J Trop Pediatr 1982;28:287-293

16. Muller M: The Baby Killer. War on Want publication, London. 1974

17. Aidou J, Benjamin A, Biddulph J et al. Bottle-feeding and the law in Papua New Guinea. Lancet 1979;2:155

18. Baumslag N, Michels DL: Milk Money and Madness: the Culture and Politics of Breastfeeding. Bergin & Garvey, USA.1995 p154-166

19. Jelliffe DB, Jelliffe EF. Feeding young infants in developing countries: comments on the current situation and future needs. Stud Fam Plann 1978;9:227-229

20. Baer E, Margulies L: Infant and young child feeding: An analysis of the WHO/UNICEF meeting. Stud Fam Plann 1980;11:72-75

21. Skeet M. How the other half dies. Nursing times 1982; Sept 22^nd:1586-1588

22. Robinson M. Infant morbidity and mortality: a study of 3266 infants. Lancet 1951;1:788-794

23. Addy DP. Infant feeding: a current view. BMJ 1976;1:1268-1271

24. Pullan CR, Toms GL, Martin AJ et al. Breast-feeding and respiratory syncytial virus infection. BMJ 1980;281:1034-1036

25. Joseph SC. The anatomy of the infant formula controversy. Am J Dis Child 1981;135: 889-892

26. May CD. The ‘Infant formula controversy’: A notorious threat to reason in matters of health. Pediatrics 1981;68:428-430

27. Barness LA. The Committee on Nutrition and the WHO Code of Marketing Breast milk Substitutes. Pediatrics 1981;68:430-431

28. Board of APA. The World Health Organization Code of Marketing Breastmilk Substitutes. Pediatrics 1981;68:432-434

29. Innocenti Declaration 2005. On infant and young child feeding.

http://www.unicef.org/programme/breastfeeding/innocenti.htm

(Accessed May 22^nd 2010)

30. Aguayo VM, Ross JS, Suleyman K et al. Monitoring compliance with the International Code of Marketing Breastmilk Substitutes in west Africa: a multisite cross sectional study in Togo and Burkina Faso. BMJ 2003;326:127-132

31. Waterston T, Tumwine J. Monitoring the marketing of infant formula feeds. BMJ;2003;326:113-114

32. Barennes H, Andriatahina T, Latthaphasavang V et al. Misperceptions and misuse of Bear Brand coffee creamer as infant food: national cross-sectional survey of consumers and pediatricians in Laos. BMJ 2008 337:a1379-a1382

33. Srour L, Barennes H: Will Nestlé’s bears continue to mislead parents and threaten infant’s lives http://www.bmj.com/cgi/eletters/337/sep09_2/a1379#213974 (Accessed May 22^nd 2010)

34. Raya RR: The Philippine breastfeeding struggle continues. Lancet 2008;371:794-795

35. Coutsoudis A, Coovadia HM, King J. The breast milk brand: promotion of child survival in the face of formula-milk marketing. Lancet 2009;374:423-425

36. Simondon KB. Workshop summary: Early breastfeeding cessation and infant mortality in low income countries. GR Goldberg et al (eds): Breast-feeding: Early Influences on Later Health. Springer Science 2009 p319-329

37. Victora CG, Smith PG, Vaughn JP et al. Evidence for protection by breast-feeding against infant deaths from infectious diseases in Brazil. Lancet 1987;2:319-322

38. Bahl R, Frost C, Kirkwood BR et al: Infant feeding patterns and risks of death and hospitalization in the first half of infancy: multicentre cohort study. Bull World Health Organ 2005;83:418-426

39. Creek TL, Kim A, Lu L et al. Hospitalization and mortality among primarily non breastfed children during a large outbreak of diarrhoea and malnutrition in Botswana, 2006. J Acquir Immune Defic Syndr 2010;53:14-19 .

40. Lauer JA, Bertrán AP, Barros AJ et al: Deaths and years of life lost due to suboptimal breast-feeding among children in the developing world: a global ecological risk assessment. Public Health Nutr 2006;9:673-685

41. Coutsoudis A, Coovadia HM, Wilfert CM. HIV, infant feeding and more perils for poor people: new WHO guidelines encourage review of formula milk policies. Bull World Health Organ. 2008;86:210–214

42. Palombi M, Marrazzi M, Voetberg A et al: Treatment acceleration program and the experience of the DREAM program in prevention of maternal-to-child transmission of HIV. AIDS 2007;21:S65-72

43. Bartick M, Reinhold A. The burden of suboptimal breastfeeding in the United States: a pediatric cost analysis. Pediatrics 2010;125:e1048-1056

44. Chantry CJ, Howard CR, Auinger P: Full breastfeeding duration and associated decrease in respiratory infection. Pediatrics 2006;117:425-432

45. Strathearn L, Mamun AA, Najman JM et al. Does breastfeeding protect against substantiated child abuse and neglect? A 15-year cohort study. Pediatrics 2009;123:483-493

46. Donnelly A, Snowden HM, Renfrew MJ et al: Commercial hospital discharge packs for breastfeeding women. Cochrane Database Syst Rev 2000; (2) CD002075

47. Wright CM, Waterston AJ. Relationships between paediatricians and infant formula milk companies. Arch Dis Child 2006;91:383-385

48. Kaplan DL, Graff KM: Marketing breastfeeding-reversing corporate influence on infant feeding practices. J Urban Health 2008;85:486-504

49. Baby Milk Action (IBFAN). Industry exploits HIV tragedy: HIV and infant feeding. 1997 http://www.babymilkaction.org/update/update21.html#25 (Accessed May 22^nd 2010)

50. Farmer PE, Nizeye B, Stulac S et al: Structural violence and clinical medicine. PLoS Med 2006;3:e449-458

51. Olness KN personal communication 2010

TABLE 1

History leading to the Code

Year Organization/ Event/Document Title/Action Reference

Author

1939 Williams Lecture Milk and Murder¹ 13

1990

1970 Jelliffe Article Commerciogenic 12

Malnutrition

1974 Muller Book The Baby Killer 16

1975 Nestlé Lawsuit Nestlé Kills Babies² 6

against Swiss

AgDW³

1977 Papua New Legislation Bottles, teats, dummies & 17

Guinea formula: prescription only

1977 INFACT⁴ Boycott All Nestlé products 6,18

1978 Kennedy US Senate Promotion of infant formula in 19 Hearing developing countries

1979 WHO/ International Infant and young child 20

UNICEF meeting feeding

1981 WHA Code passed International Code of Marketing 1 118:1 votes Breastmilk Substitutes

¹ Lecture by Dr Cicely Williams to Singapore Rotary Club

² Translation in German of “The Baby Killer”

³ Arbeitsgruppe Dritte Weit: Swiss Third World Action Group

⁴ Infant Formula Action Coalition

TABLE 2

Summary of WHO International Code of Marketing Breast Milk Substitutes¹

1. The Code covers all breast-milk substitutes marketed before

the baby is 6 months old including formula, bottles and teats

2. No advertising to the public

3. No free samples to mothers

4. No promotion of products in health care facilities

5. No company representatives to contact mothers

6. No gifts or samples to health workers

7. No baby pictures idealizing formula

8. Information to health workers to be scientific

9. All information must explain the benefits and superiority of breastfeeding

10. Unsuitable products such as sweetened condensed milk

should not be promoted for babies

11. Manufacturers and distributors to comply with above even if

country has not implemented the Code

12. Professional groups and non governmental organizations to inform manufacturers, distributors and governments of activities violating the Code

¹Adapted from references 1,4

TABLE 3

History since the Code

Year Organization Venue Title/Action Reference

/Author

1981 130 countries Legislation Restriction of aggressive 18

Marketing

1989 UNICEF Initiative Baby Friendly hospitals 8

1990 32 countries Florence Innocenti Declaration^1,2 29 Italy

1994 Nestlé Lawsuit Thrown out of court³ 7 against AAP

2003 Several Articles Blatant violations of the Code 3,4,30,31,

-2009 Authors 32,33,34

2005 Several Articles High mortality from formula 35-40

-2010 authors in developing world

1999 Several Articles Prevention of MTCT⁴ 35,41,42

-2009 authors in developing world

2009 Bartick Article The burden of suboptimal 43

breastfeeding in the United States

¹ Meeting of 32 countries in Florence Italy; declaration reconfirmed in 2005

² Passed unanimously by 32 countries; US was represented by USAID and UNICEF but not the US government which has never endorsed the Code

³ Nestlé sued AAP for restricting their right to advertise. This was thrown our of court as frivolous suit

⁴ Mother to child transmission of HIV