US FDA sodium reformulation targets projected to save lives and costs

image: Sodium consumption is a leading modifiable risk factor for high blood pressure and CVD in the US and worldwide.

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Tookapic, Pexels.com

Commercial adherence to the United States (US) Food and Drug Administration (FDA) 2016 sodium reformulation targets for processed foods will cost-effectively reduce cardiovascular disease (CVD), according to a modeling study published this week in PLOS Medicine. The study, conducted by Jonathan Pearson-Stuttard of the University of Liverpool and Imperial College London, and colleagues, estimates that, over a 20-year period, even modest adherence to the FDA targets will gain 1.1 million discounted quality-adjusted life years (QALYs) [95% Uncertainty Interval (UI) 0.91 m to 1.3 m] from reduced cases of CVD and other causes, and save $19 billion (95% UI $3.4 b to $41 b) in societal costs.

Sodium consumption is a leading modifiable risk factor for high blood pressure and CVD in the US and worldwide. To reduce sodium consumption, the US FDA in 2016 proposed 2-year and 10-year voluntary sodium reformulation targets for commercially processed, packaged, and prepared foods. However, the potential health and economic effects of these proposed targets have not been rigorously estimated.

In their study, Pearson-Stuttard and colleagues quantify the potential impact on CVD, life years and costs of the FDA proposal over a 20-year period. They use a previously validated microsimulation modeling approach, with a close-to-reality synthetic population (the US IMPACT food policy model) comparing 3 different levels of industry compliance. The researchers project that the optimal scenario--100% compliance with the 10-year FDA targets--could gain approximately 2 million QALYs [95% UI 1.7 m to 2.4 m] and produce discounted cost savings of approximately $40 billion [95% UI $14 b to $81 b]. In contrast, the modest scenario (50% compliance with the 10-year FDA targets) and the pessimistic scenario (100% compliance with the 2-year targets but no further progress) could yield health and economic gains half and a quarter as large, respectively. According to model estimates, all 3 scenarios have a greater than 80% probability of being cost-effective by 2021 (incremental cost-effectiveness ratio

Pearson-Stuttard and colleagues' projections use data from interventional and prospective observational studies, which are subject to biases and confounding. However, sensitivity analyses incorporating uncertainty in the prevalence of risk factors, the relative risks associated with these factors, the specific foods to be reformulated, and costs were factored into the reported UIs. The authors state, "suboptimal compliance or a delay in reaching these targets could result in a significant number of preventable CVD cases, CVD deaths, and costs to the wider economy."

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PLOS