Monthly Archives: November 2020

Diabetes is a growing global health concern, with the prevalence of the disease among adults rising from 4.7% to 9.1% over the past 30 years. In 2019, this represented an estimated 463 million adults around the world (expected to rise to 578 million by 2030) and caused 4.2 million deaths, costing over $760 billion in health expenditure.

For hospitalised patients with diabetes, poor glycaemic control is common. This increases the risk of perioperative infection, extends their length of stay and carries a greater risk of mortality. Addressing poor glucose control, thus, improves patient outcomes and cuts the cost of care.

The American Diabetes Association has defined two key goals for nutrition therapy of hospitalised patients: to optimise glycaemic control and provide adequate nutrients to meet metabolic demands.

Diabetes-specific formulas (DSFs) are a category of foods for special medical purposes designed to meet these objectives by not only supporting the metabolic nutritional requirements of a standard formula, but also minimising glycaemic response. DSFs are also endorsed by the European Society for Clinical Nutrition and Metabolism (ESPEN) for the nutritional support of people with obesity and diabetes.

Based on the evidence of clinical, health and economic outcomes, DSFs improve patient outcomes and cut the cost of care by: 

• Improving glucose levels and reducing glycaemic variability
• Reducing the risk of hypoglycaemia, and blunting the hyperglycaemia of stress-related metabolism
• Reducing insulin requirements
• Reducing length of stay, which leads to a reduction in total cost

Therefore, ISDI endorses the use of DSFs as a safe, efficacious and cost-effective strategy to support the management of hospitalised patients with, or at risk of, poor glucose control.

The composition of infant formulas is strictly regulated and rigorously tested by official control bodies. Occasionally, competent authorities find deviations between test results vis-à-vis regulatory parameters. One reason for the discrepancies is the use of different analytical methods.

To ensure products meet the highest standards, the global infant formula industry works to ensure a thorough understanding of the capability of an analytical method (i.e. the ability of a method to produce test results within the regulatory limits) as an additional key parameter when establishing compositional criteria for nutrients in infant formulas.

We acknowledge that all analytical test methods have some uncertainty. The key factor is understanding method variability in the context of the overall variability, which also includes variation in raw materials/ingredients and the manufacturing process. The overall variability must fit within the regulatory limits.

Recently, a cross industry group of experts performed an innovative study using existing performance data to identify suitability criteria for compliance testing. The capability of an analytical method was defined and calculated for state-of–the-art internationally recognised reference methods to establish the percentage of deviations from regulatory requirements. Compositional requirements for infant formulas (including foods for special medical purposes intended for infants) in different countries were also reviewed. 

The findings showed that the analytical method capability for vitamins A, B₁₂, D and folic acid are of concern in relation to the regulatory requirements in countries such as China, EU member states, Pakistan, Russia, Singapore, South Africa, and Thailand. In addition, a deviation was observed regarding vitamin D in Europe for products with a manufacturing target at the midpoint of regulations. In this case the probability of obtaining an analytical result outside the regulatory requirements due to analytical variation of the method alone can be as high as 19%, which can cause legal uncertainties.

The findings were recently published in the scientific journal Food Control. The paper was co-authored by a number of SPIFAN stakeholders and can be accessed here.