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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. view more 

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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 < $100,000 per QALY) and cost-saving by 2031.

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."


Research Article


This work was funded through NIH R01 grants R01HL115189 (DM) and R01HL130735 (RM). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of this manuscript.

Competing Interests:

I have read the journal's policy and the authors of this manuscript have the following competing interests: LW is employed by the American Heart Association as Director of Policy Research. RM reports grants from NIH during the conduct of the study. In addition, RM is a PI of a research grant from Unilever on an investigator-initiated project to assess the effects of omega-6 fatty acid biomarkers on diabetes and heart disease, and reports personal fees from the World Bank and Bunge; all outside the submitted work. DM reports honoraria or consulting from Astra Zeneca, Acasti Pharma, GOED, DSM, Haas Avocado Board, Nutrition Impact, Pollock Communications, Boston Heart Diagnostics, and Bunge. DM also is on the scientific advisory board for Omada Health, and Elysium Health, and receives chapter royalties from UpToDate, and also receives research funding from NIH and the Gates Foundation. JPS reports personal fees from ICF strategic consulting outside of the submitted work.


Pearson-Stuttard J, Kypridemos C, Collins B, Mozaffarian D, Huang Y, Bandosz P, et al. (2018) Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis. PLoS Med 15(4): e1002551.

Author Affiliations:

Department of Public Health and Policy, University of Liverpool, Liverpool, United Kingdom
School of Public Health, Imperial College London, London, United Kingdom
Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, United States of America
Department of Preventive Medicine and Education, Medical University of Gdansk, Gdansk, Poland
American Heart Association, Washington, District of Columbia, United States of America

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