Ready-to-Use Supplementary Foods and Ready-to-Use Therapeutic Foods

Abstract

The purpose of this commentary is to describe the current regulatory environment for the multitude of ready-to-use supplementary foods and ready-to-use therapeutic foods used in international feeding programs for undernourished and malnourished children. A perspective on the role of standards, their desirable scope, benefits and limitations as well as possible future developments of products in these categories also is provided.

The Case for Product Standards

Established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in 1963, the Codex Alimentarius is the leading world authority for international food. Its mission is to develop international food standards, guidelines, and codes of practice which contribute to the safety, quality, and fairness of international food trade. Compliance with Codex Alimentarius standards is voluntary, a safe harbor, but not mandatory. According to Codex, its members “cover 99% of the world’s population”. More and more developing countries are taking an active part in the Codex process—in many cases assisted by the Codex Trust Fund, which strives to finance—and train—participants from such countries to enable efficient participation. Being an active member of Codex helps countries to compete in sophisticated world markets—and to improve food safety for their own population. At the same time exporters know what importers demand, and importers are protected from substandard shipments.” (http://www.codexalimentarius.org/)

From a programmatic or supply chain perspective, international product standards offer the following benefits:

Ease of trade: A globally accepted definition of what a product is (or is not) facilitates trade, helps protect from barriers, and facilitates the resolution of issues. For example, the reference made to Codex food safety standards in the World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary measures (SPS Agreement) means that Codex has far-reaching implications for resolving trade disputes. The WTO members who wish to apply stricter food safety measures than those set by Codex may be required to justify these measures scientifically. Codex standards are often adopted by individual countries as their own, which, in turn, allows local suppliers to be players in international trade.

Consumer protection: The core mission of Codex regulations is to ensure the safety and quality of foods. As part of regulations, a standard may include many procedures, quality and safety specifications, and other measures designed to build a framework to protect consumers from economic and other forms of adulteration. Protection of vulnerable consumers is even more critical when the food they consume is key to their recovery and when the products represent a large part of their diet.

Supply chain security: A clear definition of products, including not only their composition but also packaging and labelling specifications, is critical for the provision of therapeutic or medical foods, even more so than for staple foods, because their consumers are, for the most part, highly vulnerable. In the absence of Codex Standards, organizations such as the United Nations World Food Programme have developed extensive guidelines for managing their supply chain of specialized nutritious foods. ¹ Yet many other public and private organizations are involved in the provision of such foods, and the lack of universally recognized standards leads to a confusing web of specifications and guidelines. The strategic use of Codex Standards is a critical part of successful business decisions all along the supply chain and would improve chain security for those serving malnourished communities, just as they create order on the market for other staple foods.

In short, products intended to manage malnutrition should be covered by international standards to protect consumers from substandard or unsafe products, to harmonize trade of such products, and facilitate free trade of such products.

What Should be the Scope of These Standards?

A Useful Framework

Developers of new ready-to-use-therapeutic-foods (RUTF) and ready-to-use-supplementary-foods (RUSF) should be able to refer to Codex for guidance on how to formulate these products to meet the needs of target populations within a country. However, national regulations regarding RUTF and RUSF also may exist, which can complicate the understanding of regulations and requirements around the world. Standardization of guidelines within Codex and acceptance by all countries would greatly ease the confusion and better serve the community.

Flexible Guidelines to Stimulate Innovation

First and foremost, standards need to allow flexibility in formulation and manufacturing. When excessively normative, they may prevent innovation. In the case of RUSF, fortified blended foods, and even RUTF, they should not be “recipes” based on a fixed set of ingredients. These products need to deliver a specified dose of nutrients, assure microbiological safety, and palatability appropriate for the targeted consumer, have adequate shelf-life and weight/volume in accordance with supply chain needs, and be free of antinutrients and contaminants. However, manufacturers should have the flexibility to use locally available ingredients and be able to optimize the formulations for cost and nutritional impact.

Emerging research suggests that RUTF and RUSF can be optimized via the use of dairy-based ingredients. Product standards can specify a content in dairy proteins, yet a variety of dairy ingredients should be allowed so that lower lactose dairy ingredients (whey or milk protein concentrates) can be used for lactose-intolerant recipients, for example. Furthermore, the use of particular ingredients may help achieve a faster lean body mass gain, improve immune function, and reduce diarrhea. Dairy products are not only a source of high-quality protein, but they also provide essential minerals and lactose, the latter which might also serve as a prebiotic. The science is emerging on actual health effects of many of these independent components in various types of dairy ingredients. New, ongoing research is constantly providing new insights on the mechanisms of action of such components, and this information will help optimize the efficacy of products in the future while taking into account the cost issues related to particular products. The set of papers forming this supplement contains information about this emerging research.

One Size does Not Fit All

Standards should be designed with the needs of the customer in mind. It is well established that the needs of recipients of RUTF are different from those of RUSF, with this latter group being highly diverse. During the 37th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in November 2015, United Nations Children’s Fund (UNICEF) introduced at Codex level a discussion paper for a Codex guideline that only addresses RUTF for the management of severe acute malnutrition (SAM); this new proposal replaced an earlier proposal that was intended to cover all ready-to-use-foods (RUFs). This judicious adjustment recognizes that, as the number of vulnerable groups that benefit from RUSF and RUTF grows so will the need for a variety of standards for these products. For example, RUSF will have to be designed specifically for the taste and needs of pregnant mothers or people living with HIV who have poor immune status and low lean body mass or for the elderly. A “one-size-fits-all” standard RUF product that delivers the desired health outcomes becomes even more improbable. The example of the proposed UNICEF standard whose scope is specific to desired outcomes for a targeted condition and narrow set of consumers is a prudent, science-based approach.

Fast Evolving Science

While early research in the field of malnutrition tended to focus on product comparisons—“Is product A equivalent or superior to product B?”—researchers in the field are now able to refine their approaches and increasingly are designing protocols that allow for fine-tuned analyses based on the role of specific nutrients. Currently, the FAO is reviewing the evidence base for the nutritional specifications of RUTF and RUSF products, and a report is expected late 2015. Additional research in the field will continue to shed light on the efficacy of other supplementary foods in various settings. These advances in science will help set forth the specifications for a variety of products.

Such new guidelines and standards should:

create a policy environment for food fortification that takes advantage of scientific advances and encourages adjustments in formulations;

focus on desired nutrients, based on quality data on their impact on outcomes;

create the right policy environment for food fortification, allow for scientific advances; and

support initiatives for use of local products to enhance acceptability.

Conclusion

There appears to be an urgent need and sufficient evidence to develop guidelines for RUTF for SAM. Standards need to recognize the unique needs of the targeted groups these products serve and protect them. They must be flexible to allow for optimization (cost, acceptability, and efficacy) as science and technology evolve and be customized as needed. And finally, they should facilitate trade of these products so that the number of beneficiaries can be maximized. One-size-fits-all normative formulations are premature for a wide set of RUF products.

This commentary is based on the presentation “Ready to Use Supplementary Foods and ready to Use Therapeutic Foods: Developing Standards,” by Dr Cindy Schweitzer, Global Dairy Platform, Rosemont, Illinois, presented at the 2015 Experimental Biology annual meeting. Opinions expressed in this commentary represent those of the Global Dairy Platform.