142 May 14, 1981 THE INFANT FORMULA CONTROVERSY INTRODUCTION The running controversy over infant formula promotion and sales in the Third World moves into a new phase this month as the World Health Assembly meets in Geneva to consider the adoption of a code r egulating the marketing of breast milk substitutes.

The proposed International Code of Marketing for Breastmilk Substitutes has drawn criticism from industry and government.

Both groups have expressed concern that the Code would lead to U.N.-imposed marketing and promotion constraints in other areas as well as foreshadow the adoption of the Code as policy rather than mere recommendation.

Also at issue are questions concerning the effectiveness of the proposed Code in reducing infant malnutrition in the Th ird World. Critics contend the Code fails to consider other facets of the malnutrition dilemma such as maternal starvation, inability to breast-feed, need to work and decision not to breast-feed.

The purpose of this paper is to review the controversy surr ounding infant formula in the developing world and examine the issues involving the proposed International Code of Marketing for Breastmilk Substitutes currently under consideration in the World Health Assembly meeting in Geneva.

BACKGROUND Until the beginning of the present century, breast-feeding was the principal source of nutrition for newborn children and remained the primary method of feeding during the child's infancy.

In the early part of the 19OOs, however, the inability of some mothers to nurse successfully prompted the research and develop2 ment of breast milk s~stitutes which could adequately replace mother's milk while still supplying the required nutrients for the growing infant.

United States, hitting a peak during the 1950s when it was est i mated that as many as 75 percent of all mothers were substituting formula for breast-feeding for at least part of the infant's first year of life The popularity of formula feeding grew steadily in the As the consumption of infant formula slowly declined in the 19608, the formula industry began to concentrate on Third World countries, where demand for breast milk substitutes had sharply increased In response to the growing concern over infant malnutrition in the developing nations of the world, the intern a tional health community initiated a series of meetings in the early 1970s under the direction of the Pan American Health Organization, UNICEF and the Protein Advisory Group (PAG), a United Nations agency charged with overseeing and evaluating the nutritio n al require ments and successes in developing nations. Meeting in Paris in 1972, the PAG approved a document Statement 23 which affirmed the superiority of breast-feeding whenever possible, while recog nizing the need for alternative infant foods when brea s t-feeding proves impossible for whatever reas0n.l The PAG pointed to the need for collective action on the part of sovereign governments, United Nations organizations, the various private and public relief groups, members of the health care community, and the infant formula industry, advocating a comprehensive approach to reducing infant malnutrition through a variety of programs at all levels.

Specifically, PAG called on governments and agencies to recognize the urgency of the infant malnutrition problem and to place the development and planning of food sources on a high priority At the same time, it maintained that it "is clearly important to avoid any action which would accelerate the trend away from breastfeeding I2 PAG assigned the role of promoting b reast-feeding to the health care profession, while charging governments with the responsibility of ensuring that nutritionally adequate substitute foods be available in the event breast-feeding was not possible.

In 1974, the World Health Assem bly initiated a series of studies in nine countries representing a variety of different geographical, climatic and developmental conditions I' The study Protein Advisory Group Statement No. 23, Paris, 1972 Ibid at 1-2. 3 found that the decision to breast- f eed was related most significant ly to whether the mother lived and functioned in a rural or urban community. tutes was llextensive,ll but the direct effect of advertising and promotional practices on patterns of breast-feeding was not determined The over a ll exposure of mothers to breast milk substi Beginning in 1978, the World Health Assembly took up the question of regulating the promotion of breast milk substitutes in developing nations. In October 1979, the Joint W.H.O./UNICEF Meeting on Infant and You n g Child Feeding presented a statement of policy which emphasized "that marketing substitutes and weaning foods should be designed not to discourage breastfeeding.lf3 The Meeting recommended a ban on 1. all promotion of breast milk substitutes, supplements and feeding bottles directly to the'general public 2. the distribution of all free samples; and 3. any promotional devices which suggested the superior ity of any product over natural mother's milk.4 The text was followed in May 1980 by the draft Internat ional Code of Marketing of Breastmilk Substitutes which was approved by the W.H.O. Executive Council on January 28, 1981, and forwarded to the World Health Assembly for consideration this month in Switzerland.

Responding to increasing concern over infant f ormila and its possible adverse effects on nutrition in the Third World, manufac turers of breast milk substitutes met in Zurich in 197.5 to organize the International Council of Infant Food Industries (ICIFI The ICIFI set forth a "Code of Ethics and Prof e ssional Standardst1 which suggested levels of performance regarding advertising product information, promotion and instructive services'for breast milk substitutes In paragraphs 2, 3 and 4, the Code affirms the superiority of breast-feeding whenever possi ble and details the importance of informing mothers on the use of infant formula and the necessity of following proper sanitation procedures in its preparation.

Since that time, the industry has continued its emphasis on self-regulation both through the In ternational Council of Infant Food Industries and independent corporate effort World Health Organization, Joint W.H.O./UNICEF Meeting on Infant and Young Child Feeding: Statement, Recommendations, and List of Participants 1979 art. 8 Ibid art. 28, 29 6' 4 The popular movement opposed to marketing infant formula. in developing nations began in earnest in August of 1973 with the publication of an article entitled !!The Baby Food Tragedy If which appeared in a British publication called the New Internationali st.

The article, which was actually an interview with Dr. R. G Hendrickse and Dr. David Morley (tropical medicine experts charged that Western corporations had in part contributed to the problem of infant malnutrition through overly zealous marketing techn iques, but that other factors were more to blame.

Shortly thereafter, War on Want, a British charity organiza tion, published a special report entitled "The Baby Killer1 authored by journalist Mike Muller. The Muller report synthesized the various charges of promotional malfeasance levied against the formula industry and was rather direct in its accusations, insist ing that "Third World babies are dying because their mothers bottle feed them with Western style infant milk 115 It further charged that multi national corporations are promoting artificial substitutes which are a prime cause of needless death and disease.

Swiss activist organization, the Third World Workjng Group, under the title of !'Nestle Kills Babies.I Muller's piece was translated in German and published by a One year later, in the spring of 1975, independent film maker Peter Kreig went to Kenya to produce what later became one of the most compelling attacks on the use of infant formula and its promotion in the less developed Third World.

T hough the Kreig film has, itself, been attacked by those who participated in it as distorted and deliberately misleading the Third World Institute in Minneapolis along with other activist groups like the National Council of Churches, began to circulate th e piece nationwide. More recent works, including CBS Reports I production of I'Into the Mouths of Babes" and the Packard Manse Media's "Guess Who Is Coming to Breakfast," have added fuel to the .anti-formula coalition.

On July 4, 1977, 'the Third World Institute of the Newman Center and the Minnesota Infant Formula Action Coalition simulta neously formed INFACT (Infant Formula Action Coalition) and initiated a nationwide boycott of all'NestleIs U.S. products.

The boycott was quickly endorsed by a number of social activists including Ralph Nader, Cesar Chavez, Dr. Benjamin Spock, Drs.

Derrick Jellife and Michael Latham. Additionally, the boycott has drawn support from the National Education Association, the National Council of Churches, and strongly leftist groups such as Mother Jones Magazine, Berkeley Citizens Action, and Earthwork Mike Muller, "The Baby Killer London: War on Want, 1974 p. 2. 5 There has been some response from the governments of develop ing nations, Papua New Guinea, the Philippines, Jam aica and Venezuela have adopted various codes directed at the marketing of infant formula, while other nations are currently considering such a move.

The United States Congress acted positively on legislation promoting the quality of infant formula produce d, while refusing to consider several other proposals which would have placed restrictions on the marketing of infant formula domestically and abroad.

BREAST MILK IS BEST ROLE OF INFANT FORMULA The preamble of the Draft International Code of Marketing of Breastmilk Substitutes (ICMBS) states that breastfeeding is an unequalled way of providing ideal food for the healthy growth and development of infants Equally important, the Code recog nizes that infant formula has a significant role to play in providing adequate nutrition among children denied breast-feeding when mothers do not breastfeed...there is legitimate market for infant formula and for suitable ingredients from which to prepare it; that all these products should accordingly be made accessible to t hose who need them 'through commercial or non-commercial distribution systems The W.H.O. recognizes, therefore, the need for breast milk substitutes and the critically important role that these products play in stemming the problem of infant malnutrition in the develop- ing world. However, the Code itself is constructed contrary to this stated premise, and in fact penalizes the mother who cannot or does not wish to breast-feed her infant.

The decision to breast-feed depends on several conditions.

First, the mother must be sufficiently nourished and free of disease to provide breast milk of adequate quantity and quality for her nursing infant. Secondly, the mother must be free to breast-feed and have access to conditions which allow for success ful breast-feeding, independent of constraints placed on mothers forced to work in factories or away from home and children.

Thirdly, the mother herself must choose to breast feed her children most likely turn to a breast milk substitute for partial or comple te feeding of her children. If infant formulas are not available, then she will be forced to use substitute foods such as cereal gruels made of water and maize, rice or millet flours crackers, sugar-water or mashed fruits. The nutritional quality of these native foods is low and their nature and consistency make it difficult for children to digest, thereby robbing the child of nutrients vital to proper growth and development If any of the above conditions are not met, the mother will 6 In these instances, t he introduction of infant'formula is crucial and fills the nutritional needs of the child whose mother cannot or chooses not to breast-feed bias contained in the Code may have.a correspondingly negative impact on infant nutrition by discouraging the most e ffective and medically sound alternative to breast milk, rather than upgrading infant health as it claims to The clearly anti-formula MARKETING OF INFANT FORMULA The proposed Code rests on the incorrect assumption that marketing practices employed in the promotion of infant formula are the primary cause in the decline of breast-feeding in the developing world, leading eventually to infant morbidity and mortality.

There is, however, little empirical evidence to suggest that changes in traditional patterns of breast-feeding in the Third World have occurred as a direct result of marketing techniques.

Dr R. G. Hendriske, interviewed in an early article written against the use of infant formula, maintains there are a number of factors which influence the decisi on to breast-feed, most notably "need to worki1 and Itinsufficient milk" on the part of the mother. He added Itit would be a mistake if we believed that the drift away from breast-feeding is entirely due to the seduction of advertising It6 W.H.O.'s own st u dy on breast-feeding, reporting information based on interviews with 23,000 mothers, f.ailed to show any causative relationship between commercial activity and breast-feed ing practices Even so, the Code seeks to regulate only marketing practices and fail s to address the more significant causes of the decline in beast-feeding mentioned above. Equally dangerous, the Code eliminates those services provided by the industry designed to aid the mother in preparing and administering the formula to her children.

The use of llmothercraft nursesi1 or similar personnel is not permitted by the code (see art. 6.4 Preparation and use of infant formula is to be demonstrated by hospital or government health workers only, unnecessarily overtaxing already understaffed hosp itals and health clinics and reducing the availability of 6 "The Baby Food Tragedy," Interview with Dr. R. G. Hendrikse and Dr. David 7 Morley, New Internationalist, August 1973, p. 12.

W.H.O. Collaborative Study on Breastfeeding: Methods and Main Results of the First Phase of the Study (Preliminary Report W.H.O MCH, 1979. 7 information necessary in the proper application of breast milk substitutes.

With the improper mixing and use of infant formulas cited as a major concern among critics of the formula industry, this section of the Code increases the opportunity for error and corresponding infant malnutrition.

Clearly, there is little scientific evidence to justify the notion that marketing practices of industry have been the primary cause of infant death in the Third World asserts that infant formula is to blame for premature death in babies, thereby directing attention away from the real killers of children: disease, unsanitary living conditions, impure water and lack of nutritious diet supplements The C ode dangerously POLITICAL QUESTIONS AND RAMIFICATIONS Not only will the proposed CodF on breast milk substitutes have a profound impact on the international infant population but it will also have a pervasive spillover effect in other non-formula areas. T h e instituting of a code regulating the marketing and internal business practices of private industry by an international organization would set a dangerous precedence in the arena of world business regulation, particularly in light of similar moves in UNE SCO and at the'Law of the Sea Convention.

Even though it is currently presented in recommendation form only, Article 11 calls on the ratifying states to take action on the Code "including the adoption of national legislation, regula tions or other suitable measures" (Article 11.1 The W.H.O. may also upgrade the current draft code from recommendation to policy by a future vote of the World Assembly. It is important to recognize that the action taken in Geneva this month may lay the groundwork for legislativ e action in the future which may prove contrary to the free market system.

Second, the Code is to be implemented in all nations who are currently members of the W.H.O. and participate in the Assembly.

The draft text would be technically binding on all sta tes whether they voted for it or not and in all regions of the globe regardless of need or existing national law. The effect on consumers by the marketing of infant formula is greatly different in.Senega1 as opposed to the United States or Great Britain, a nd the legal restrictions should be tailored accordingly. The proposed text is clearly designed for those regions of the world with a less commercially-sophisticated audience and would be of little value in most Western nations of the proposed Code are fu ndamentally contrary to U.S. law as it relates to commercial activities in the United States and abroad.

The arbitrary prohibition of advertising and product information Finally, it is important 'to recognize that several provisions 8 dissemination would make its implementation impossible here and in other Western nations with similar free market systems.

Secretary of Health and Human Services Richard Schweiker reinforced this view when he declared that the Code could not be Itenforced in the United States because it 'runs contrary to the Constitution on the First Amendment' and would violate antitrust laws.11a INDUSTRY SELF-REGULATION In 1975, representatives of the infant formula industry met in Zurich to organize the International Council of Infant Food Industries (ICIFI The Council then prepared a !'Code of Ethics and Professional Standards" which 1. affirmed the preference for breastfeeding when possible (par 2, 3, 4 2 calls for Ilexplicitly worded instructionsIt to safeguard against improper use and p reparation of infant formula (par 5 3. emphasizes the need for potable water before infant formula is introduced (par 6 4. govern the conduct and use of personnel and Ilmother craft nurses and similar personnel (par. 7-12).

In addition to the ICIFI code, several manufacturers. have implemented policies to promote breast-feeding and minimize the improper use of breast milk substitutes. Bristol-Meyers for example, requires that its product labels state that breast milk is the best food for infants and should be used whenever possible.

Additionally, the company forbids direct advertising to consumers through the media in developing countries and has hired an outside auditing firm to insure compliance. Bristol-Meyers and Nestle's have both discontinued the use of "mothercraft nursesi1 and milk craft personnel Though Abbott Laboratories has continued to use Irmothercraft nurses the term of their employment is strictly regulated.

Like Bristol-Meyers, they forbid the use of media advertising and restrict formula promotion to medical professionals, providing samples only to health care personnel and at their request.

Product labels stress the importance of breast-feeding and instruc tions have .been simplified and pictographs added.

In like manner, Wyeth International has added pictographs to their labels, which declare in bold'type that breast-feeding.is a "Rules on Infant Formula Called Unconstitutional The Washington Post May 13, 1981, p. A8. the 9 most preferred method for feedin g infants. Wyeth does not disaibute samples directly to consumers nor does it use mass media advertising to promote its products. The company encourages health care professionals to evaluate critically the financial constraints placed on each mother befor e recommending the use of breast milk substitutes.

The industry recognizes the importance of regulating the use, distribution and promotion of infant breast milk substitutes and has demonstrated the success of self-regulation. Volunteer regulation initiate d by the private sector is vastly superior in both the long and short run to an international agreement inflexi ble to location, custom or existing national law, and one which arbitrarily would remove a major portion of the information services available to mothers of the Third World.

CONCLUSION There is no doubt that breast-feeding is the most preferred method of infant nutrition. Given a healthy mother, it provides most of the necessary nutrients in a vehicle best suited for the child nursing their child ren should be made after carefully weighing all other alternatives Any decision not to breast-feed by mothers capable of If a mother then decides to employ a breast milk substitute either by choice or by necessity, infant formula is vastly superior to nat ive substitute foods and should be readily available.

The proposed International Code of Marketing of Breastmilk Substitutes severely restricts the access and information options available to Third World mothers. The inflexible and often anti-formula natur e of the Code distorts milk substitute use in such a manner as to be potentially dangerous for the child whose mother cannot or does not want to breast-feed the question of breast I There have been abuses and distortions on both sides of the infant formul a dilemma in the past. Industry has already demon strated the ability and desire to imposeregulation on itself in line with those dictated by the Code. The implementation of the proposed draft is unnecessary, potentially disastrous and politi cally dangero us, for it would set a precedent for subsequent regulation of industry in other areas as well I The problem of infant malnutrition is real and compelling.

The draft text currently under consideration in Geneva, however fails to address the central issues o f starvation in developing countries and will act only as an impediment to reducing the suffering of those infants who might otherwise benefit from access to infant formula.

Guy M. Hicks Policy Analyst