Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline

This article discusses the value of a Ready-to-use Therapeutic Food (RUTF) and the guidelines for its use. The author explains that because RUTFs are used in the treatment of children with Severe Acute Malnutrition (SAM) without medical complications, a guideline could help ensure products are safe, efficacious and of good quality. She concludes by noting how careful consideration of what should be included in the guideline, as well as provision for consultation with various stakeholders, are required to ensure safety and efficacy being achieved.
 
Introduction
 
Childhood undernutrition is a major global health problem contributing to childhood morbidity, mortality and impaired intellectual development. Later in life, it also may lead to suboptimal adult work capacity and increased disease risk.¹ Undernutrition contributes to approximately 45% of deaths among children under the age of five, mainly in low and middle-income countries. Several forms of malnutrition exist, and these burdens bear down on millions of children, with 15.95 million children affected by wasting and growth stunting and 8.23 million children affected by growth stunting and being overweight.²
 
Children affected by Severe Acute Malnutrition (SAM) can be identified by measuring their Mid-Upper Arm Circumference (MUAC).³ A MUAC of less than 115 mm, in children six to 59 months, indicates SAM, which requires treatment. A weight for height z-score of more than three standard deviations also indicates SAM.⁴ Patients with SAM are classified into two groups: those with and those without medical complications. So that they can be stabilized, hospitalization is only required for patients with SAM and medical complications. Those without medical complications can be managed in an outpatient therapeutic care setting.  Treatment of complicated SAM is divided into phases. The first phase—or the stabilization phase—involves the use of a milk-based formula called F-75 (low protein, low energy feed). There is generally a transition phase before patients move to the rehabilitation phase, during which another milk-based formula, F-100 (high protein, high energy feed), is used. There is no clear guideline on how the gradual transition from stabilization to rehabilitation in the therapeutic feeding should be carried out. During the transition phase, feeds gradually change from F-75 to F-100 or Ready-to-use Therapeutic Food (RUTF).⁵
 
The World Health Organization (WHO) recommends the use RUTF during the rehabilitation phase. RUTF is a lipid-based therapeutic food⁶ with a high energy content and contains adequate amounts of vitamins and minerals.⁷ The major ingredients typically include ground peanuts, oil, sugar, milk powder, vitamins and minerals.⁸ They are soft or crushable foods that can easily be consumed by children from the age of six months onward, without requiring the addition of water. Its nutrient composition is similar to F-100 used in hospital settings.⁹
 
RUTF is a Food for Special Medical Purposes (FSMP)¹⁰ and has been shown to be effective in the treatment for various forms of SAM, such as kwashiorkor, nutritional marasmus and severe wasting.¹¹ A standard dose of RUTF adjusted to the weight of the patient can be given to a malnourished child with an appetite when there are no medical complications. Children can consume RUTF with minimal supervision at home, often directly from the package, at any time of the day or night.^12,13  
 
RUTF offers the possibility of the rehabilitation phase of treatment to be completed at home for several reasons:¹⁴
 

• It provides all the nutrients required for recovery of acute malnutrition.¹⁵
• The feed is not water-based, which means the risk of bacterial growth is very limited. This makes RUTF safe to use where hygiene conditions are not optimal and without refrigeration at household level.^16,17
• It does not spoil easily, even after opening.¹⁸
• It is provided in the format “ready-to-use.”
• It is palatable and trials have shown that most children like the taste and may eagerly consume it.¹⁹

 
United Nations (UN) agencies, such as UNICEF support the Community-based Management of Acute Malnutrition (CMAM) with RUTF.²⁰ Since the endorsement, RUTF as part of the dietary management of uncomplicated SAM has saved millions of lives of children, through improved coverage of nutrition programmes, reduced mortality rates, timely treatment of SAM and reduced costs of hospital care.²¹
 
Defining International Standards for RUTF
 
Although it offers an efficacious treatment option for SAM, RUTFs are not without criticism. One concern is the potential for commercial exploitation beyond the treatment of SAM.²² It is also often seen as expensive, even though typically sponsored by the United Nations Children's Fund (UNICEF).²³ It is more expensive than the usual locally available food, which is sometimes used.²⁴
 
Few countries, even where there is a high prevalence of SAM, have specific national policies for addressing SAM comprehensively.²⁵ Some have their own bureau of standards working on defining national standards for RUTF, but standards should be harmonized from the beginning.²⁶ Although UNICEF provides technical support to governmental and non-governmental organizations on the use of RUTF,²⁷ no UN agency or any organization has yet defined or standardized the composition and quality standards for RUTF.²⁸ Thus, there is no official, international standard for countries to follow. Some purchasing agencies write their specifications based on the 2007 Joint Statement on Community-based Management of Acute Malnutrition and technical guidance.²⁹
 
It has been suggested that RUTF should be regulated by an independent body, not directly involved with the purchasing and use of the products. Such a guideline would provide a reassuring framework, facilitating endorsement of new producers/products and ensuring consumer protection. It also can be used as an appropriate reference for imported or locally produced products to facilitate local regulation and encourage allocation of national budgets to these products.³⁰ During the 37th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) in 2015, the Committee agreed to establish an electronic working group, chaired by South Africa and co-chaired by Senegal and Uganda, to develop guidelines for RUTF for children with SAM.³¹ The work is ongoing and the guidelines aim to include:³²
 

• A description of the product, (as it seems as if there is no universal agreement on what should be termed an RUTF).³³
• Guidelines on raw materials and ingredients requirements. Raw materials used in RUTF need to comply with relevant CODEX Standards,³⁴ e.g., the Codex standard for Milk Powders and Cream Powder (CXS 207-1999).³⁵ It is recommended that RUTF formulations also comply with Section 3 of the Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CXS 180-1991) including the specification that their use should have been scientifically demonstrated to be safe and beneficial in meeting the nutritional requirements of children with SAM.³⁶
• Nutritional composition and quality factors, which includes macro-nutrients as well as essential micro-nutrients.³⁷
• The largest safety concern for peanut-based RUTFs is probably aflatoxin contamination (application for inclusion RUTF). As a result of hot, humid cultivation and storage conditions promoting fungal growth, aflatoxins contaminate food such as maize and groundnuts. In addition to aflatoxin, with its well-known toxicological effect,³⁸ the guidelines also will focus on other contaminants. Guidelines will be provided on the safety and acceptable levels of toxins and other potentially harmful ingredients³⁹ and will take existing Codex standards into account such STAN 193-1995 General Standard for Contaminants and Toxins in Food and Feed.⁴⁰
• Technologies for processing, which include milling, roasting or toasting of ingredients. RUTF and/or the raw materials used should be treated with a validated microbial reduction treatment in order to inactivate pathogens such as Salmonella.⁴¹
• Microbiological criteria from several documents were applied for RUTF and some purchasing agencies have developed their own safety requirements.⁴² Universally agreed upon guidelines for good manufacturing practices and hygiene practices will be included,⁴³ such as Code of Hygienic Practices for low-moisture foods (CAC/RCP 75-2015).⁴⁴
• Methods of analysis and sampling will be considered. Guidelines are needed to support access to adequate national laboratories capable of testing for nutrients and toxins.⁴⁵
• Packaging guidelines aim at ensuring RUTF is packaged in such a way to safeguard the hygienic and other qualities, including its nutritional properties for the duration of its defined shelf-life. The packaging materials should only be made of substances that are safe and suitable for its intended use.⁴⁶
• RUTF is often seen as a threat to breastfeeding. Guidelines are required to control the promotion and marketing of RUTF, which should take into account relevant aims and principles and provisions in the WHO International Code on the Marketing of Breastmilk Substitutes.⁴⁷ For these reasons, the guideline will provide some guidance on labelling.⁴⁸

 
To adequately address all the issues needing to be covered in the guideline, various stakeholders⁴⁹ should convene in a transparent, independent and inclusive process to include commercially interested parties and observers.⁵⁰ This would include UN agencies, purchasers, users, consumers, manufacturers, laboratories and national governments or authorities who set standards to protect the health of consumers. Exchanges between all stakeholders would encourage a better understanding of each other’s needs and constraints.⁵¹
 
Manufacturers should be consulted as they have experience in the development and production of RUTF, and new requirements, which may differ from what is currently produced, could lead to stock-outs. Alternatively, production may become unviable or significant investments may be required, which may be challenging to implement. Manufacturers should be given a time period to implement adequate measures to ensure compliance with new specifications. It is also essential to consider the end users’ input. Community health workers, for example, know the reality “on the ground” and the environments in which such products are consumed.⁵²
 
RUTF has saved thousands of lives in recent years⁵³ and a Codex guideline could help to:

• facilitate trade disputes and provide guidance on importation requirements
• provide a framework for sustainable procurement of quality products
• provide an official global reference for manufactures on the minimum requirements for RUTF.⁵⁴ This will help to ensure products are safe, efficacious and of a good quality.
• provide an advocacy opportunity for children’s rights to good nutrition
• provide an opportunity to clarify certain aspects, e.g., contaminants so that the formulation can be improved
• assist in the development of a regulatory framework at national levels⁵⁵

 
Conclusion
 
RUTF, when properly used, is safe. However, RUTF should not be seen as a substitute for best nutritional practices, breastfeeding or normal household food. It should be considered part of the medical management of SAM and should only be used in conjunction with necessary primary healthcare as well as in accordance with international standards for such care. It is also not the solution to all forms of SAM. Children under the age of six months and those suffering from medical complications, such as appetite loss, severe oedema, anorexia, high fever or severe hydration, require inpatient treatment. It also should not be used for the prevention of child malnutrition.⁵⁶  Once finalized, the Codex guideline also should not be seen as a substitute for rational and sustainable policies and programs to combat all forms of malnutrition.⁵⁷ However, a guideline could help ensure RUFT products are safe, efficacious and of a good quality.⁵⁸
 
References
 

1. World Health Organization. Guideline: Updates on the Management Of Severe Acute Malnutrition in Infants and Children. Geneva: World Health Organization. 2013.
2. UNICEF. Global Nutrition Report. https://globalnutritionreport.org/reports/global-nutrition-report-2018/. Published 2018. Accessed 10 June 2019.
3. A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s Fund. 2007. Community-based Management of Severe Acute Malnutrition.
4. Schoonees A, Lombard M, Musekiwa A, Nel E and Volmink J. “Ready-to-use Therapeutic Food for Home-based Treatment of Severe Acute Malnutrition in children From Sixmonths to Five Years of age (Review).” Cochrane Database of Systematic Reviews 2013, Issue 6.
5. Lanyero B, Namusoke H, Nabukeera-Barungi N, et al. “Transition From F075 to Ready-to-use Therapeutic Food in Children With Severe Acute Malnutrition, an Observational Study in Uganda.” Nutrition Journal. 2017;16:52.
6. Ibid.
7. Op cit 3.
8. United Nations Children’s Fund. Position Paper: Ready-to-use Therapeutic Food for Children With Severe Acute Malnutrition. UNICEF Nutrition; 2013;1:1-4.
9. Op cit 3.
10. Codex Alimentarius Commission. Report of the Physical Working Group on the Proposed Draft Guideline for Ready-to-use Therapeutic Foods. 2018.
11. Latham MC, Jonsson U, Sterken E and Kent G. RUTF Stuff. Can the children be saved with fortified peanut paste? World Nutrition. 2011;2(2):62-85.
12. Op cit 3.
13. Op cit 8.
14. Op cit 5.
15. Op cit 8.
16. Op cit 3
17. Op cit 8.
18. Op cit 8
19. Op cit 11
20. Op cit 8.
21. Op cit 5.
22. Op cit 8.
23. Duclercq M. “Production of Ready-to-Use Food (RUF): An Overview of the Steps and Challenges Involved in the “Local” Production of RUF.” CMAM Forum. 2014:1-42.
24. Op cit 11.
25. Op cit 3.
26. Op cit 23.
27. Op cit 8.
28. Op cit 11.
29. Op cit 23.
30. Op cit 23.
31. Codex Alimentarius Commission. Report of the 37^th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). 2015.
32. Codex Alimentarius Commission. Report of the 40^th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). 2018.
33. Op cit 11.
34. Op cit 32.
35. Codex Standard for Milk Powders and Cream Powder. CODEX STAN 207-1999.
36. Op cit 32.
37. Op cit 11.
38. Op cit 23.
39. Op cit 11.
40. General Standard for Contaminants and Toxins in Food and Feed. CODEX STAN 193-1995.
41. Op cit 32.
42. Op cit 23.
43. Op cit 32.
44. Code of Hygienic Practices for low-Moisture Foods. CODEX STAN 75-2015.
45. Op cit 11.
46. Op cit 32.
47. Op cit 11.
48. Op cit 10.
49. Op cit 23.
50. Op cit 11.
51. Op cit 23.
52. Op cit 23
53. Op cit 8.
54. Fleet A. Codex Guideline for RUTF. Presented at UNICEF Nutrition Supplier Meeting; June 2017; Denmark. https://www.unicef.org/supply/files/1340_Codex_update_2107.pdf. Accessed 10 June 2019.
55. Fleet A. Update on RUTF Codex Guideline. Presented at UNICEF Supply Division Meeting; June 2018; Copenhagen. https://www.unicef.org/supply/files/1415_Normative_and_Standard_Setting_Codex_update.pdf. Accessed 10 June 2019.
56. Op cit 8.
57. Op cit 11.
58. Op cit 55.

 
Disclaimer
This article reflects the personal opinion and experience of the author. It should not be construed as an official position by any organization with which the author is affiliated.
 
About the Author
 
Louise T. Göttsche has been working as scientific and regulatory affairs manager at Aspen Nutritionals for the past four years. She has worked within the nutritional industry for 12 years and currently leads the International Special Dietary Foods Industries (ISDI) RUTF taskforce. Göttsche is a PhD candidate (University of Stellenbosch) and holds an MBA (University of South Africa) and MSc in dietetics (North West University). She can be contacted at LGottsche@aspenpharma.com.
 
Cite as: Göttsche L.T. “Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline.” Regulatory Focus. June 2019. Regulatory Affairs Professionals Society.