Ready-to-use therapeutic foods (RUTF) have become a common method of treating SAM and are easier to use and distribute during nutritional emergencies. Furthermore, RUTFs do not require water for preparation, and are shelf stable for up to 2 years, which are advantages over the former inpatient treatment, and are generally palatable to children with an appetite, as the usual form of RUTF is a sweet, peanut-based, nutrient-enriched paste [9
]. These have proven effective at treating SAM and moderate acute malnutrition (MAM) in many settings [10
], however, there is evidence that RUFT may not be effective when scaled up in primary health care settings [16
]. The present review, referring primarily to non-emergency situations, considered the following: (1) important drawbacks and limitations to RUTFs; (2) increased demand for and use of these products; (3) investigation of the sustainability of RUTFs, both for long-term human health during global nutrition transitions, and environmental sustainability; and (4) strategies which may prevent or mitigate any future health issues arising from the use of RUTF in mothers and children.
1.1. History of Ready to Use Therapeutic Foods for Children
RUTFs have allowed for the treatment of uncomplicated cases of SAM with appetite in the home/community, with care provided by mothers and supervision by community health workers, commonly through the community-based management of acute malnutrition (CMAM) program which was officially endorsed by the World Health Organization and other international agencies in 2007 [8
]. This approach has allowed for greater numbers of affected children to receive adequate treatment and reach full recovery [17
]. Alongside this, the rapid success of the CMAM program has led to the use of RUTFs as the often preferred means of SAM treatment in preference to potentially more cost-effective and sustainable alternatives, as well as the development of similar products for use beyond the original intentions of RUTFs for the home-based treatment of SAM in emergencies. United Nations Children’s Fund (UNICEF) is the largest global procurer of RUTF and provides technical support and guidance to organizations on its use, but has also had to defend use of RUTF in a position paper [18
] which noted that RUTFs should be seen as medical treatment for SAM and should not be viewed as a ‘panacea’ for treatment and prevention of all cases of malnutrition; they also noted care is needed to ensure that RUTFs do not become a replacement for nutritional best practices and consumption of normal household foods.
In treatment of SAM, once children have been stabilized and begin to have an appetite, they enter the rehabilitation or ‘catch up’ phase and can begin to have F-100 (100 kcal/100 mL) which requires clean water to reconstitute the formula [3
]. Lack of clean water and refrigeration in communities and the need to measure and mix the product (increasing possibility of error), were the primary factors limiting the possibility of safe home-care for the majority of children suffering SAM. The advent of RUTFs overcame these practical problems. RUTFs were developed by various nutritionists and eventually, through the Institut de Recherche pour le Developpement (IRD), which blended the formula with peanut butter, produced a long-lasting, high-energy and high-protein therapeutic food providing 543 kcal/100 g (more than five times the energy density of F-100) and equivalent to F-100 in terms of nutrients/100 kcal [9
]. The resulting product does not require additional resources by the end-user and is logistically attractive in emergency situations where large numbers have to be fed, local food is unavailable, or health care resources are strained. The first commercially produced RUTF was patented by the French producer, Nutriset, with IRD, and came to be known as Plumpy’Nut [20
Nutriset’s patent of the process and method of production of its RUTF initially limited the possibility of local production in low-income settings where it was needed most. However, in 2005, Nutriset founded PlumpyField, a network of Plumpy’Nut manufacturers licensed to produce Plumpy’Nut through a franchise model [21
]. Subsequently, many PlumpyField factories have been built in countries where the product is needed, and produce the RUTF from more locally sourced foods [21
]. This expansion has led to a 7-fold increase in production capacity from 2007 to 2014, with Nutriset’s network now able to produce over 100,000 metric tons (MT) of product per year [22
]. However, production capacity seems to be far outpacing actual production, perhaps with the aim to capture as much of the future market as possible and to improve ability to respond to emergencies; in 2014 53,000 MT of Nutriset products were produced [22
Further, in 2010, the Nutriset patent was made available online (with an attendant usage agreement) for the benefit of developing countries, allowing independent producers to make peanut-based RUTF in selected countries [20
]. It should be noted that this occurred only after a spate of adverse publicity including articles in the New York Times questioning ethics [23
], as well as threats of litigation from other organizations hoping to produce the paste; though these threats ultimately failed to overturn the patent, Nutriset made its patent available for use in selected developing countries for the production of generic versions of RUTF. Through PlumpyField and the opening of the patent for use by developing countries, many companies are now producing RUTF, either as Plumpy’Nut (in the case of the PlumpyField network) or under another name, both in low-income country settings and in high-income settings.
Production of RUTF in the countries that need and use the product has many potential benefits. Locally-manufactured RUTFs using locally-sourced ingredients should perform as well as imported RUTFs (e.g., Plumpy’Nut) as long as these meet the WHO specifications for composition and adhere to careful quality control measures to avoid contamination of unprocessed peanuts with aflatoxin [24
]. Alternative base ingredients that are grown in the country ensure the child does not become accustomed to foods that are normally unavailable. Local production would greatly improve sustainability, minimize transport of the end product and associated costs along with potential transport-related delays, reduce tariffs, and employ citizens in the countries where it is needed. Additionally, local production could theoretically boost the economy within these countries as long as the profits were reinvested locally and ultimately accrued to benefit residents.
Despite the shift towards increasing production in end-use countries, the large majority of Plumpy’Nut is still produced by Nutriset in France, with the next largest producer being Edesia (a Nutriset licensee) in the US—almost two-thirds of Plumpy’Nut produced in 2014 was manufactured by Nutriset (in France) with about one-quarter coming from the non-Edesia members of the PlumpyField network [22
]. UNICEF has stated that 22% of their 2013 procurement came from Africa [25
Since the initial development of Nutriset’s Plumpy’Nut, RUTF has become the preferred method of addressing nutritional emergencies through both the United Nations and non-governmental channels, and attendant resources have been channeled into the purchase and use of RUTF on an enormous scale. UNICEF’s demand for RUTF has increased from less than 9000 MT in 2009 to over 30,000 MT in 2014, with the large majority going to African countries such as Ethiopia, Kenya, and Somalia, where environmental conditions including cyclical drought cause re-occuring food shortages [26
]. One thousand metric tons of RUTF treats approximately 76,500 children for about 3.6 million USD (based on an average price of $
50 per 150-sachet carton at approximately 13.8 kg per carton) [27
]. A UNICEF 2013 evaluation of CMAM found the purchase of RUTF accounted for 50% of CMAM operating costs in one Ethiopia case study [30
The proliferation of RUTF for the treatment of SAM has led to an increase in producers and a parallel expansion of the product range for use in treating MAM, stunting and for meeting general nutritional needs as a form of prevention, rather than its initially intended purpose of treatment of severe acute undernutrition. It is likely that in many cases, this use of RUTF and these new products has by default resulted in replacement of some of the family foods children would normally be eating. It may also impact negatively on continued breastfeeding of children older than 6 months (children <6 months old are not given RUTF). It is costly and a heavy logistical burden for local health systems to import RUTF. Often, producers of RUTF products do not use locally sourced ingredients, nor does the majority of production occur in the end-use countries [22
]. In short, currently RUTF is neither logistically sustainable nor financially feasible for the end users. The following sections provide evidence of these problems.
1.3. Development of an Industry
The potential for further expansion of this product category, and its market worth, has not escaped the attention of the private sector and a large conflict of interest problem has developed. Privately financed factories producing RUTF can hardly keep up with the expanding demand for the products. Recently, Abbott Nutritionals, maker of infant formulas and breastmilk substitutes, built a production facility as a donation for the non-governmental organization Partners in Health to produce Nourimanba RUTF in Haiti [31
]. Additionally, private entities putatively dedicated to improving nutrition worldwide (but having no vested interest in public health) have sprung up to produce RUTF and other ready-to-use products through business licenses with Nutriset PlumpyField or through other entrepreneurial ventures.
One such factory, owned and run by a self-described social enterprise called Edesia Nutrition, was started by a person who was inspired by an episode of 60 min wherein journalist Anderson Cooper proclaimed Plumpy’Nut to be a “miracle food” [32
]. With no background or training in nutrition or public health, President of the Board of Trustees and Executive Director Navyn Salem (financed by her venture capitalist spouse, Vice President, Paul Salem), became a Nutriset licensee in 2009 and built a large factory in Rhode Island, United States to produce RUTF [23
]; and the factory has just finished an expansion to double its production capacity in 2016.
By all accounts the company has thrived on its commercial production and sales of ready-to-use products, shipping 9000 MT per year, and advertises an ever expanding portfolio of products, including most of the Nutriset line along with their own proprietary product, Peanut POW, described as ‘a Lipid-based Nutrient Supplement Medium Quantity (LNS-MQ—50 g) for schoolchildren three years of age and older to complement foods available during school hours and to address nutrient gaps’ [34
], which is marketed to afterschool programs and supplementary feeding programs in the United States. The Peanut POW packaging, in contrast to traditional Nutriset products, closely resembles that of a candy bar with a colorful blue, foil wrapper and animated peanut superhero. From the financial materials required by law to be provided publicly, it is stated that the product produced in largest quantities by Edesia is Plumpy’Sup, for supplementation and treatment of MAM, rather than Plumpy’Nut [35
]. Edesia ostensibly operates as a non-profit, but website materials explicitly describe ‘securing new business opportunities related to commercial avenues in both domestic and international markets’, ‘executing annual sales plan to support revenue and profit objectives’, as well as ‘market research on target countries and regions’ and ‘establishing and growing company brand awareness to penetrate international markets with new or current products’ [36
]. Notably, there are no such statements about improving the nutrition situation or public nutrition beyond the sales of RUTF. One portion of the website describes this: ‘We often tell visitors to our factory that one $
55 box equals the life of one child’ [37
]. Annual reports, blogs, and website and marketing materials of Edesia and other companies producing RUTF inevitably feature emotionally-targeted photos of undernourished (usually black) children from poor countries, photogenically clutching packages of RUTF, while others provide testimonials of mothers lauding the benefits of the product, and before and after photosets.
Similarly, MANA nutrition based in North Carolina with a factory that produces RUTF in Georgia is at work refining their own proprietary supplementary feeding product to prevent MAM [38
]. Another company, Valid Nutrition, based in Ireland and operated as a not-for-profit (but which counts former Unilever executives on its board of directors) produces their own brand of RUTF at a factory in Malawi using large percentages of locally sourced ingredients. Valid has also already expanded its product lines beyond treatment of SAM to ready-to-use supplementary and complementary foods for treating MAM and preventing chronic malnutrition [39
]. The 2015 annual report notes, ‘This is the first step in a progressive programme we have designed to start the process of unlocking this potentially massive market’ [40
]. It recently expanded operations to India in partnership with India’s largest private food brand and dairy, Amul [40
], which sells vast quantities of milk powder and sugar sweetened beverages, to manufacture RUTF there. The head of Valid recently stated, ‘We need evidence to demonstrate that a public/private collaboration selling complementary foods through retail channels can improve health whilst generating a financial return for investors’ [42
]. The Valid Nutrition business model aims for the factories to be self-funding through more traditional business means of sales and marketing, rather than relying on government funding and charitable donations; the latest annual report states: ‘VALID Nutrition aims to be a self-sustaining social enterprise funded through the sales and marketing of effective low cost nutritional products’ [40
]. Additionally, Valid Nutrition’s sister company, Valid International, which shares the same founder and executive director/chairman, acts as a consulting group, providing technical support on implementation, monitoring and evaluation of health and nutrition programs, including CMAM and chronic malnutrition listed as specific focus areas [43
] (a quote from Valid International’s website indicates their role in providing technical support: “Valid International specialises in the provision of expert technical support and the research, development and implementation of techniques to improve the quality, impact and accountability of any endeavour that aims to improve global health and nutrition. Our mission is to improve global health and nutrition with evidence-based, equitable, high impact solutions”).
Where it happens, the practice of the physician (or his wife) owning the pharmacy next to the clinic, where prescriptions are filled, is regarded as highly undesirable due to the clear conflict of interest. NGOs whose mission is to provide technical assessments in emergencies should clearly have no role in then providing the supplies they may recommend, thus in the type of assistance favored.
These cases illustrate how expansion of producers of RUTF have led to a parallel expansion in the development of ready-to-use foods for consumption outside of the treatment of SAM in the form of ready-to-use supplementary and complementary foods for both treatment and prevention of moderate and chronic malnutrition in both children and women. It seems clear based on the language used by these companies themselves that the development of these products is more essential for their growth and prosperity than for the best interest of the targeted end user.
Other companies have sprung up capitalizing on the expanding demand for RUTF and specifically Plumpy’Nut, which is often referred to, without irony, as a “miracle food.” One private company called This Bar Saves Lives uses a buy-one-give-one model to provide one packet of Plumpy’Nut for each snack bar purchased and its website promotional video describes Plumpy’Nut this way: ‘look, this is a huge problem [malnutrition], but what’s crazy is there is a really simple solution’ [44
]. This Bar Saves Lives advertises that they focus on both treatment, through the giving of PlumpyNut, and prevention, through the giving of Nutributter [46
]. Similarly, Calorie Cloud, a partner of US-based RUTF producer MANA as well as UNICEF, publicizes the ability to help people in the US (notably corporate employees) ‘recycle’ their calories by counting activity and weight loss and donating equivalent RUTF packets through MANA [47
]. In another example of private-public interest in RUTF, Toddler Food Partners, a US-based company which provides ‘knowledge, equipment and hands-on training to make Ready to Use Therapeutic Food (RUTF)’ has recently partnered in India with Hexagon Nutrition Private Limited (HNPL), a pharmaceutical corporation, General Mills India office, the State Nutrition Mission and Tata Chemicals among other Indian organizations, to study, scale up and produce a local ready-to-use food and has plans for the development of future products [48
Similar to Edesia, these companies often employ arguably unethical marketing techniques that have been described as ‘social pornography’ in the past, using images of nearly naked African children in a most vulnerable state of extreme hunger and suffering, while showing little respect for the dignity of the person involved given the extremely personal nature of such a state [49
]. The ‘Our Cause’ page of This Bar Saves Lives gives a perfect example of this, displaying a before and after illustration of an African boy who, in the ‘before’ image appears emaciated with ribs protruding, while looking at the camera with wide eyes and a frightened look; only in the ‘after’ picture does the boy wear a shirt [46
]. The European NGO confederation for relief and development, CONCORD, has adopted a formal Code of Conduct on Images and Messages in which it describes that images should be used that respect human dignity, truthfully depict the broader context of the situation, and avoid stereotyping or sensationalizing, among other principles [51
]. The Irish association of non-governmental development organizations, Dochas, published a visual guide to the Code [52
], wherein several sections describe the types of imagery used by the companies described here (e.g., the image from This Bar Saves Lives) as examples of what not to do. The non-EU based companies identified in this paper may not be subject to this code, but the existence thereof within the international development community suggests an understanding of the unethical nature of such marketing practices.
This explosion of activity centered around production, marketing and sales of ready-to-use foods and corporate partnerships, amounts to the exploitation of undernutrition for revenue generation, and even in the instance of a not-for-profit organization, poses major ethical challenges to appropriate, objective use and promotion of RUTF for its intended purpose.
As Jeffrey Sachs wrote in response to news coverage distorting the use of RUTF, ‘of the billion or so people in our world suffering from undernourishment, Plumpy’Nut is appropriate only for a small fraction. Most of the chronically under-nourished need not a solution to acute under-nutrition through food aid but regular access to a long-term, balanced healthy diet’ [53
]. Sachs, who warned that the general public should be helped to understand the differences between acute and chronic hunger, and the need for different approaches to address each, went on to describe the ‘real solutions of improved local agriculture, improved household dietary practices, and expanded access of the poor to basic healthcare’ as those needed to address global malnutrition.
UNICEF mentions, in its position paper on the use of RUTF, its firm intention to adhere to the established international norms and guidelines for infant and young child feeding [18
]. These include: exclusive breastfeeding for the first six months of life, followed by continued breastfeeding and the use of appropriate complementary foods for children 6–24 months; micronutrient supplementation for vulnerable groups; and advocating best practices for child nutrition, health and hygiene. It is in the context of this important statement and ethical obligation that we argue the use of RUTF and related ready-to-use-foods in situations other than therapeutic treatment of child undernutrition does not constitute use of appropriate complementary foods nor best practices for child nutrition and health. The next sections outline the problems associated with RUTF.