Abstract

Introduction

Chronic Non-Communicable Diseases (NCDs) are an important public health problem because they are globally the main cause of death in recent decades, and cardiovascular diseases have been contributing most to deaths due to NCDs ¹1. World Health Organization. Global health estimates 2018: disease burden by cause, sex, by country and region, 2000-2016. https://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html (acessado em 18/Fev/2022).
https://www.who.int/healthinfo/global_bu... . In Brazil, cardiovascular diseases account for about 30% of deaths ²2. Malta DC, Andrade SSCA, Oliveira TP, Moura L, Prado RR, Souza MFM. Probabilidade de morte prematura por doenças crônicas não transmissíveis, Brasil e regiões, projeções para 2025. Rev Bras Epidemiol 2019; 22:E190030. and have a high economic impact, with the direct and indirect costs of cardiovascular diseases estimated at BRL 37.1 billion in 2015, which corresponded to 0.7% of the country’s Gross Domestic Product (GDP) ³3. Siqueira ASE, Siqueira-Filho AG, Land MGP. Analysis of the economic impact of cardiovascular diseases in the last five years in Brazil. Arq Bras Cardiol 2017; 109:39-46.. Of all NCDs, arterial hypertension costed more than BRL 2 billion per year for the Brazilian Unified National Health System (SUS) in 2018 ⁴4. Nilson EAF, Andrade RCS, Brito DA, De Oliveira ML. Custos atribuíveis à obesidade, hipertensão e diabetes no Sistema Único de Saúde em 2018. Rev Panam Salud Pública 2020; 44:e32..

Inadequate nutrition stands out among the main modifiable risk factors for the occurrence of NCDs. A total of 11 million deaths and 255 million disability adjusted life tears (DALYs) are attributed to dietary risk factors, among which high sodium intake contributes to three million deaths and 70 million DALYs ⁵5. GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2019; 393:1958-72.. Considering the documented association of high sodium intake with increased blood pressure and with the increased risk of cardiovascular disease, stroke and coronary heart disease in adults, the World Health Organization (WHO) recommends that sodium intake be less than 2g/day, the equivalent of 5g/day of salt ⁶6. World Health Organization. Guideline: sodium intake for adults and children; 2012. https://www.who.int/publications/i/item/9789241504836 (acessado em 18/Fev/2022).
https://www.who.int/publications/i/item/... .

In Brazil, the average salt consumption is 9.3g/day, almost double that recommended by WHO ⁷7. Mill JG, Malta DC, Machado IE, Pate A, Pereira CA, Jaime PC, et al. Estimativa do consumo de sal pela população brasileira: resultado da Pesquisa Nacional de Saúde 2013. Rev Bras Epidemiol 2019; 22 Suppl 2:E190009.. According to the Brazilian Household Budget Survey (POF 2008-2009), which evaluated the food consumption of the Brazilian population, the main dietary sources of sodium are the direct addition of salt and salt-based seasonings to foods (74.4%) and the consumption of processed and ultra-processed foods (20.5%) ⁸8. Sarno F, Claro RM, Levy RB, Bandoni DH, Monteiro CA. Estimated sodium intake for the Brazilian population, 2008-2009. Rev Saúde Pública 2013; 47:517-78.^,99. Monteiro CA, Levy RB. Velhos e novos males da saúde no brasil: de Geisel a Dilma. São Paulo: Editora Hucitec; 2015.. It is estimated that the reduction of the average salt intake of Brazilians to 5g/day in adults over 30 years could prevent or delay more than 46,000 deaths per year from cardiovascular diseases and save BRL 662 million in costs to the SUS with the treatment of cardiovascular diseases ¹⁰10. Nilson EAF, Silva EN, Jaime PC. Developing and applying a costing tool for hypertension and related cardiovascular disease: attributable costs to salt/sodium consumption. J Clin Hypertens (Greenwich) 2020; 22:642-8.^,1111. Nilson EAF, Metzler AB, Labonte M-E, Jaime PC. Modelling the effect of compliance with WHO salt recommendations on cardiovascular disease mortality and costs in Brazil. PLoS One 2020; 15:e0235514..

The WHO proposes the goal of reducing the average population sodium intake by 30% by 2020 as a strategy to contribute to the prevention and control of NCDs ¹²12. World Health Organzation. Global action plan for the prevention and control of noncommunicable diseases 2013-2020. Geneva: World Health Organization; 2013.. Nationally, to cope with NCDs, the Brazilian National Food and Nutrition Policy (PNAN) addresses the reduction of salt consumption ¹³13. Ministério da Saúde. Política Nacional de Alimentação e Nutrição. https://bvsms.saude.gov.br/bvs/publicacoes/politica_nacional_alimentacao_nutricao.pdf (acessado em 18/Fev/2022).
https://bvsms.saude.gov.br/bvs/publicaco... , especially from the Food Guide for the Brazilian Population¹⁴14. Departamento de Atenção Básica, Secretaria de Atenção à Saúde, Ministério da Saúde. Guia alimentar para a população brasileira. Brasília: Ministério da Saúde; 2014., which provides the guideline for the promotion of adequate and healthy food, and, additionally, through the reformulation agenda of the nutritional profile of processed and ultra-processed foods. Also, there is the Strategic Action Plan to Tackle Non-Communicable Diseases, which established the goal of reducing the average consumption of salt and showed the regulation of the nutritional composition of foods to reduce sodium levels as one of the main actions in the healthy eating axis, aiming to preventing NCDs and promoting health ¹⁵15. Ministério da Saúde. Plano de ações estratégicas para o enfrentamento das doenças crônicas não transmissíveis (DCNT) no Brasil 2011-2022. Brasília: Ministério da Saúde; 2011. (Série B. Textos Básicos de Saúde)..

Overall, the reduction of sodium content in processed and ultra-processed foods is recognized as cost-effective for reducing sodium consumption at the population level ¹⁶16. Hyseni L, Elliot-Green A, Lloyd-Williams F, Kypridemos C, O'Flaherty M, McGill R, et al. Systematic review of dietary salt reduction policies: evidence for an effectiveness hierarchy? PLoS One 2017; 12:e0177535.. To this end, voluntary or regulatory (mandatory) strategies have been commonly implemented to establish maximum and sometimes average sodium limits in foods around the world ¹⁷17. Wyness LA, Butriss JL, Stanner SA. Reducing the population's sodium intake: the UK Food Standards Agency's salt reduction programme. Public Health Nutr 2012; 15:254-61.^,1818. Health Canada. Sodium reduction in processed foods in Canada: an evaluation of progress toward voluntary targets from 2012 to 2016. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-food-industry-reducing-sodium-processed-foods-progress-report-2017.html (acessado em 18/Fev/2022).
https://www.canada.ca/en/health-canada/s... ^,1919. Castronuovo L, Allemandi L, Tiscornia V, Champagne B, Campbell N, Schoj V. Analysis of a voluntary initiative to reduce sodium in processed and ultra-processed food products in Argentina: the views of public and private sector representatives. Cad Saúde Pública 2017; 33:e00014316.^,2020. Peters SAE, Dunford E, Ware LJ, Harris T, Walker A, Wicks M, et al. The sodium content of processed foods in South Africa during the introduction of mandatory sodium limits. Nutrients 2017; 9:E404.^,2121. Food and Drug Administration. Draft guidance for industry: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods for voluntary sodium reduction goals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-target-mean-and-upper-bound-concentrations-sodium-commercially-processed (acessado em 18/Fev/2022).
https://www.fda.gov/regulatory-informati... . Based on the experience of countries in the Americas, including Argentina, Brazil, Canada, Chile and the United States, the Pan American Health Organization (PAHO) has also proposed regional goals, aiming to support countries at different stages of developing national policies related to food reformulation ²²22. Campbell N, Legowski B, Legetic B, Nilson E, L'Abbé M. Inaugural maximum values for sodium in processed food products in the americas. J Clin Hypertens 2015; 17:611-3..

In Brazil, since 2011, voluntary agreements between the Brazilian Ministry of Health and the associations of the food production sector have been implementing the food reformulation agenda. The agreements set out the agreed targets, i.e. the establishment of maximum limits, for the gradual reduction of sodium levels in priority categories of processed and ultra-processed foods, including salt-based seasonings and bouillon cubes ²³23. Nilson EAF, Jaime PC, Resende DO. Iniciativas desenvolvidas no Brasil para a redução do teor de sódio em alimentos processados. Rev Panam Salud Pública 2013; 32:287-92.^,2424. Ministério da Saúde. I Termo de Compromisso com a finalidade de estabelecer metas nacionais para a redução do teor de sódio em alimentos processados no Brasil. http://189.28.128.100/dab/docs/portaldab/documentos/termo_abia_abip_abima_abitrigo_2011.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,2525. Ministério da Saúde. II Termo de Compromisso com a finalidade de estabelecer metas nacionais para a redução do teor de sódio em alimentos processados no Brasil. http://189.28.128.100/dab/docs/portaldab/documentos/termo_5_dez_2011.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,2626. Ministério da Saúde. III Termo de Compromisso com a finalidade de estabelecer metas nacionais para a redução do teor de sódio em alimentos processados no Brasil. http://189.28.128.100/dab/docs/portaldab/documentos/termo_6_ago_2012.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,2727. Ministério da Saúde. IV Termo de Compromisso com a finalidade de estabelecer metas nacionais para a redução do teor de sódio em alimentos processados no Brasil. http://189.28.128.100/dab/docs/portaldab/documentos/termo_nov_2013.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,2828. Ministério da Saúde. V Termo de Compromisso com a finalidade de estabelecer metas nacionais para a redução do teor de sódio em alimentos processados no Brasil. http://189.28.128.100/dab/docs/portaldab/documentos/promocao/V_termo_alimentos_proces_2018pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... . The results of the monitoring of these agreements show that more than half of the priority categories showed a significant reduction of 8 to 34% of the average sodium content of food, in the period from 2011 to 2017 ²⁹29. Nilson EAF, Spaniol AM, Gonçalves VSS, Moura I, Silva SA, L'Abbé M, et al. Sodium reduction in processed foods in Brazil: Analysis of food categories and voluntary targets from 2011 to 2017. Nutrients 2017; 9:E742.. Despite the positive results of meeting the voluntary goals, the associations of the food production sector have limited coverage and represent around 70% of the market, currently. In addition, the agreed targets can still be more restrictive in order to achieve greater reductions in sodium levels in foods, considering limits applied in other countries and, thus, provide lower health risks ²¹21. Food and Drug Administration. Draft guidance for industry: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods for voluntary sodium reduction goals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-target-mean-and-upper-bound-concentrations-sodium-commercially-processed (acessado em 18/Fev/2022).
https://www.fda.gov/regulatory-informati... ^,3030. Public Health England. Salt reduction targets for 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/604338/Salt_reduction_targets_for_2017.pdf (acessado em 18/Fev/2022).
https://assets.publishing.service.gov.uk... ^,3131. Argentina. Secretaría de Regulación y Gestión Sanitaria. Resolución Conjunta 1/2018. https://www.argentina.gob.ar/normativa/nacional/resolución-1-2018-317245/texto (acessado em 24/Jan/2020).
https://www.argentina.gob.ar/normativa/n... ^,3232. Ministério da Saúde. I Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/relatorio_de_monitoramento_I_termo_de_compromisso.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... .

Thus, this article aims to evaluate the impact of different policy scenarios for reducing sodium consumption from processed and ultra-processed foods on the prevention of deaths due to cardiovascular outcomes in the adult population in Brazil.

Materials and methods

This study was based on secondary data, obtained from official reports and public databases of SUS health information systems and population surveys, and therefore is exempt from ethical approval. The design of the study was based on the estimation of the reduction of per capita sodium consumption by the Brazilian population in different scenarios of targets for maximum sodium limits and the impact in terms of attributable deaths through statistical modeling by macrosimulation in these scenarios, from the data synthesized in Box 1.

Sample and study population

Data collection

The data on sodium levels in foods covered different categories of processed and ultra-processed foods, contemplated in the Brazilian voluntary agreements and which, according to the POF of 2008-2009, contributed mostly to excessive sodium intake. They were: instant noodles, sliced bread, dinner rolls, cakes and cake mixtures, rocamboles, sweet, salted and stuffed cookies, French fries and shoestring potatoes, corn chips, mayonnaise, margarine, morning cereals, ready-made bouillon cubes, seasonings, soups, meat products (hamburgers, sausages, ham and breaded foods) and dairy products.

Such data are available in the reports containing an evaluation of the agreed targets for sodium reduction in priority categories of processed foods within the framework of the National Plan for Sodium Reduction in Processed Foods of the Brazilian Ministry of Health ³²32. Ministério da Saúde. I Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/relatorio_de_monitoramento_I_termo_de_compromisso.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,3333. Ministério da Saúde. II Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/relatorio_de_monitoramento_II_termo_de_compromisso.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,3434. Ministério da Saúde. III Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/promocao/relatorio_motitoramento_consolidado_17_18.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... . We obtained the information from the declaration of the sodium content available on the food label by an information search of the mandatory nutritional labeling, conducted on the official websites of companies. When this information was not available, we requested the data from contacting the Consumer Service Department (SAC) through e-mail and/or telephone. An electronic spreadsheet, developed to consolidate the information of these foods, recorded the collected data.

We obtained the sodium consumption of the Brazilian population in 2013, disaggregated by age group and sex, from the microdata of the laboratory analyses of the Brazilian National Health Survey (PNS 2013) ⁷7. Mill JG, Malta DC, Machado IE, Pate A, Pereira CA, Jaime PC, et al. Estimativa do consumo de sal pela população brasileira: resultado da Pesquisa Nacional de Saúde 2013. Rev Bras Epidemiol 2019; 22 Suppl 2:E190009.. Food consumption was obtained from the microdata of POF 2008-2009 ³⁵35. Instituto Brasileiro de Geografia e Estatística. Aquisição alimentar domiciliar per capita - Pesquisa de Orçamentos Familiares - POF 2008-2009. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2010.. The two surveys, conducted by the Brazilian Institute of Geography and Statistics (IBGE), are representative household surveys of the Brazilian population, with regional breakdown and by urban and rural area; data on food consumption (POF) and urinary sodium excretion (PNS) are also disaggregated by sex and age group for the adult population.

In this study, we obtained demographic and mortality data, respectively, from the public databases of the IBGE and the Brazilian Mortality Information System of the SUS (SIM/SUS). We stratified the population and mortality data by sex, considering age groups with intervals of 5 years, and based the causes of death on the International Classification of Diseases, 10th revision (ICD-10).

Data analysis

We estimated the average sodium levels in the food categories from the data collected, after standardization of the sodium levels of the portion identified in the nutritional labeling for 100g of each food. Then, we performed a descriptive analysis of the data in terms of measures of central trend (means and medians) and dispersion (standard deviations and maximum and minimum values), considering the sodium levels at two distinct moments: at the baseline, that is, the period before the agreement of targets (between 2011 and 2013); and in the official monitoring of compliance with the targets carried out in 2017.

We estimated sodium consumption in 2017 from the difference between the consumption evaluated in 2013 ⁷7. Mill JG, Malta DC, Machado IE, Pate A, Pereira CA, Jaime PC, et al. Estimativa do consumo de sal pela população brasileira: resultado da Pesquisa Nacional de Saúde 2013. Rev Bras Epidemiol 2019; 22 Suppl 2:E190009. and changes in sodium consumption, calculated from the consumption of processed and ultra-processed foods using the POF 2008-2009 microdata ³⁵35. Instituto Brasileiro de Geografia e Estatística. Aquisição alimentar domiciliar per capita - Pesquisa de Orçamentos Familiares - POF 2008-2009. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2010.. Therefore, we assumed that food consumption (in kilograms) would not change over time, replacing the amount of sodium in each product (in g/100g) by the average sodium content of the products in 2011 (baseline) and in 2017 (counterfactual scenarios). We calculated the most pessimistic counterfactual scenario (maintenance of national voluntary targets) considering the maximum voluntary limits for 70% of the consumption of each category, corresponding to the estimated representativeness of the Brazilian Association of Food Industries (ABIA) in the Brazilian market, and considering the average sodium content of the remaining 30% unchanged, corresponding to the products of the companies that are not part of the voluntary agreements (equal to the average content in the baseline). The other two scenarios presuppose mandatory limits, that is, established by specific regulations, which reach the entire Brazilian market. The intermediate scenario corresponds to the replacement of the maximum sodium limit in each category by the lowest national target in the Americas, in 2014 ²²22. Campbell N, Legowski B, Legetic B, Nilson E, L'Abbé M. Inaugural maximum values for sodium in processed food products in the americas. J Clin Hypertens 2015; 17:611-3.; and the optimistic scenario, to the replacement of the maximum sodium limits by the lowest targets in force in the world, in 2017-2018 ²¹21. Food and Drug Administration. Draft guidance for industry: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods for voluntary sodium reduction goals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-target-mean-and-upper-bound-concentrations-sodium-commercially-processed (acessado em 18/Fev/2022).
https://www.fda.gov/regulatory-informati... ^,3030. Public Health England. Salt reduction targets for 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/604338/Salt_reduction_targets_for_2017.pdf (acessado em 18/Fev/2022).
https://assets.publishing.service.gov.uk... ^,3131. Argentina. Secretaría de Regulación y Gestión Sanitaria. Resolución Conjunta 1/2018. https://www.argentina.gob.ar/normativa/nacional/resolución-1-2018-317245/texto (acessado em 24/Jan/2020).
https://www.argentina.gob.ar/normativa/n... .

We used sodium consumption in each reduction scenario, based on voluntary and mandatory policies and the maximum consumption recommended by the WHO (2g sodium or 5g salt), as inputs for the modeling of prevented or delayed deaths in 2027, compared to sodium consumption at the baseline in 2013, using the Preventable Risk Integrated ModEl (PRIME) ³⁶36. Scarborough P, Harrington RA, Mizdrak A, Zhou LM, Doherty A. The Preventable Risk Integrated ModEl and its use to estimate the health impact of public health policy scenarios. Scientifica (Cairo) 2014; 2014:748750.. The modeling of the policy scenarios incorporated the lag time of a few weeks between changes in the food profile (reduction of sodium content), the estimated sodium consumption and the onset of systolic blood pressure reduction ³⁷37. He FJ, Li J, MacGregor GA. Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomised trials. BMJ 2013; 346:f1325., and from five years for changes in cardiovascular outcomes in the adult population aged 30 years or older, which gradually increase from then on ³⁸38. Lawes C, Vander Hoorn S, Law MPE, MacMahon SAR. High blood pressure. In: Ezzati M, Lopez AD, Rodgers A, Murray CJL, editors. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors. Geneva: World Health Organization; 2004. p. 281-390.^,3939. Capewell S, O'Flaherty M. Rapid mortality falls after risk-factor changes in populations. Lancet 2011; 378:752-3.^,4040. Capewell S, O'Flaherty M. Can dietary changes rapidly decrease cardiovascular mortality rates? Eur Heart J 2011; 32:1187-9.. Thus, the impacts of having reduced sodium content by 2017 will result in impacts on cardiovascular mortality after 2022, and it was assumed that they would approach their maximum impact after 10 years or more after reduction in consumption (2027). To estimate mortality in 2027, we assumed that the mortality per inhabitant would remain proportional to that of 2017, adjusted by population and age distribution and by sex estimated for 2027 ⁴¹41. Instituto Brasileiro de Geografia e Estatística. Estimativas da população 2021. https://www.ibge.gov.br/en/statistics/social/population/18448-population-estimates.html?=&t=o-que-e (acessado em 18/Fev/2022).
https://www.ibge.gov.br/en/statistics/so... .

PRIME is a macrosimulation scenario modeling methodology developed by the University of Oxford (United Kingdom) to estimate changes in gender-adjusted distribution and age group from changes in one or more risk factors for NCDs, such as diet, physical activity, alcohol consumption and smoking, in population mortality, including intermediate factors such as body mass index (BMI), blood pressure and blood cholesterol. The model parameterizes the risk factors and mortality due to NCDs based on meta-analyses of epidemiological studies ³⁶36. Scarborough P, Harrington RA, Mizdrak A, Zhou LM, Doherty A. The Preventable Risk Integrated ModEl and its use to estimate the health impact of public health policy scenarios. Scientifica (Cairo) 2014; 2014:748750..

The data used by PRIME include estimates of annual deaths from NCDs by sex and age group, population by sex and age group, distribution of behavioral risk factors at the baseline and distribution of risk factors in the counterfactual scenario of interest (in this case sodium consumption in each scenario).

The parameterization of sodium intake, changes in systolic blood pressure ³⁷37. He FJ, Li J, MacGregor GA. Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomised trials. BMJ 2013; 346:f1325. and alterations in blood pressure and cardiovascular outcomes ⁴²42. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360:1903-13. are the basis for the estimates of the impact of sodium intake on cardiovascular outcomes through PRIME. The model first parameterizes the changes in sodium consumption, converted into equivalent salt consumption, and their effects on systolic blood pressure (SBP), creating a linear estimate of SBP increase for each gram of salt added to the diet, and then parameterizes these 1g intervals in salt consumption to generate a combined relative risk to associate sodium consumption with mortality due to cardiovascular diseases, mediated by blood pressure.

Within the model matrix, we performed a sensitivity analysis to generate medians and 95% uncertainty intervals (95%UI), with 10,000 interactions in Monte Carlo simulations, which calculates, in a probabilistic way, the distribution of the model input parameters (salt/sodium consumption, relative risks and mortality) to adjust the final results of the modeling ⁴³43. Koerkamp BG, Stijnen T, Weinstein MC, Hunink MGM. The combined analysis of uncertainty and patient heterogeneity in medical decision models. Med Decis Making 2011; 31:650-61.^,4444. Steenland K, Armstrong B. An overview of methods for calculating the burden of disease due to specific risk factors. Epidemiology 2006; 17:512-9..

In general, modeling studies with probabilistic approaches represent an estimate of the magnitude of the impact of different policies or counterfactual scenarios, and this should guide the interpretation of the results. The results uncertainty intervals, on the other hand, express the uncertainty of the model input parameters, including the uncertainties of exposure to risk factors (such as sodium consumption variance) and the relative risks of meta-analyses, through sensitivity analysis.

Results

Considering the more pessimistic counterfactual scenario, that is, the maintenance of the Brazilian voluntary targets, we estimated that the average salt consumption per capita would decrease, between 2013 and 2017, to 9.1g/day (pessimistic scenario). On the other hand, considering mandatory targets in the same period, the average consumption would decrease to 8.8g/day if applying the lower targets of the Americas (intermediate scenario), and to 8.5g/day if adopting in Brazil the lower international targets (optimistic scenario), as detailed in Table 1.

If by 2027 the average salt consumption in Brazil in 2013 (at 9.3g/day) remained unchanged, the mortality attributable to excessive salt consumption (greater than 5g/day) would be 72,399 deaths (95%UI: 30,314-112,781) in 2027. From these changes in consumption, we estimated the deaths prevented or delayed in each reduction scenario. The continuity of voluntary sodium reduction targets could result in the prevention and delay of up to 4,001 deaths (95%UI: 1,611-6,563) from cardiovascular diseases in Brazil by 2027, of which 2,242 deaths are due to ischemic heart disease and cerebrovascular diseases.

Considering the regulatory scenarios of targets for sodium content in processed and ultra-processed foods, we estimate that, in the same period, the adoption of the lowest regional PAHO targets would lead to more than double (9,704 deaths, 95%UI: 3,955-15,665) and the lowest international targets, to almost four times more deaths prevented or delayed (15,561 deaths, 95%UI: 6,350-25,096). Considering ischemic heart disease and cerebrovascular disease, the adoption of the lowest regional targets in the Americas would prevent or postpone 5,479 deaths, and 8,815 deaths with the lowest international targets (Table 2).

In all scenarios, more than half of the prevented or delayed deaths would be in people under 75 years of age, reaching 59% among men and 37% among women. Among the causes of death, 57% are attributed to ischemic heart diseases (predominantly myocardial infarction) and cerebrovascular diseases (strokes), as well as 33% to hypertensive diseases and 7% to heart failure.

Discussion

This study reinforces that excessive sodium consumption is a public health problem in Brazil and that, if we maintained the levels of sodium consumption of 2013, more than 72 thousand deaths from cardiovascular diseases could be attributed to excessive sodium consumption in 2027. Considering the different scenarios of sodium content reduction, the maintenance of the strategy of voluntary targets in the country until 2027 could prevent or delay 5.5% of these deaths, while if we adopted mandatory targets according to the lower limits adopted in the Americas and the world, respectively, 7.6% and 12.2% of deaths attributable to excess sodium could be prevented or delayed.

Therefore, the voluntary targets established for the reduction of sodium content in processed and ultra-processed foods will have limited impacts in relation to the mandatory adoption of other regional and global reduction benchmarks. In this sense, there are three main explanations: the limited scope and adherence to reductions by industries, the amount of categories involved and the maximum limits practiced so far in Brazil, based on the voluntary agreements ⁴⁵45. Campbell N, Legowski B, Legetic B, Ferrante D, Nilson E, Campbell C, et al. Targets and timelines for reducing salt in processed food in the Americas. J Clin Hypertens 2014; 16:619-23..

Regarding the achievement of voluntary goals, in the Brazilian case, the goals have as a limit the market representativeness of the companies that are part of ABIA, with which the Brazilian Ministry of Health established these voluntary commitments, estimated at 70%. In addition, related to the fulfillment of the goals, even within the universe of manufacturers belonging to the association, not everyone achieves the stipulated goals, and there are no mechanisms of pressure or sanctions applicable. For example, the achievement of the targets by industries in Brazil has shown a percentage drop in the last official monitoring from 90% to 87%, between 2013 and 2017; while many categories had reached the targets above 90%, some categories had percentages lower than 70% ³²32. Ministério da Saúde. I Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/relatorio_de_monitoramento_I_termo_de_compromisso.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,3333. Ministério da Saúde. II Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/relatorio_de_monitoramento_II_termo_de_compromisso.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... ^,3434. Ministério da Saúde. III Fase do Monitoramento do Plano Nacional de Redução do Sódio em Alimentos Processados. http://189.28.128.100/dab/docs/portaldab/documentos/promocao/relatorio_motitoramento_consolidado_17_18.pdf (acessado em 18/Fev/2022).
http://189.28.128.100/dab/docs/portaldab... .

In this sense, mandatory reduction targets, established by specific regulations, can generate repercussions and health sanctions in the event of non-compliance, in addition to being applicable to all products and manufacturers in the national market. Argentina is an example of a country where voluntary measures initiated national targets for sodium reduction in products and subsequently passed to regulatory limits ⁴⁶46. Allemandi L, Tiscornia MV, Ponce M, Castronuovo L, Dunford E, Schoj V. Sodium content in processed foods in Argentina: compliance with the national law. Cardiovasc Diagn Ther 2015; 5:197-206.^,4747. Allemandi L, Tiscornia MVMMV, Guarnieri L, Castronuovo L, Martins E. Monitoring sodium content in processed foods in Argentina 2017-2018: compliance with national legislation and regional targets. Nutrients 2019; 11:E1474.. Moreover, even in internationally recognized voluntary experiments with significant impacts on sodium consumption and population health outcomes, such as that of the United Kingdom ⁴⁸48. Eyles H, Webster J, Jebb S, Capelin C, Neal B, Ni Mhurchu C. Impact of the UK voluntary sodium reduction targets on the sodium content of processed foods from 2006 to 2011: Analysis of household consumer panel data. Prev Med (Baltim) 2013; 57:555-60., the decrease in the adherence of the productive sector and the weakening of official and external monitoring led to a large reduction in the impact of the measures ⁴⁹49. Laverty AA, Kypridemos C, Seferidi P, Vamos EP, Pearson-Stuttard J, Collins B, et al. Quantifying the impact of the public health responsibility Deal on salt intake, cardiovascular disease and gastric cancer burdens: interrupted time series and microsimulation study. J Epidemiol Community Health 2018; 73:881-7..

The methodology adopted in Brazil to select priority categories based on participation in sodium consumption, according to national surveys, allows efforts to be directed to the main sources of sodium ²³23. Nilson EAF, Jaime PC, Resende DO. Iniciativas desenvolvidas no Brasil para a redução do teor de sódio em alimentos processados. Rev Panam Salud Pública 2013; 32:287-92., but excludes from the targets around 10% of the categories. Thus, broadening the targets for other categories, including sauces, canned vegetables, other dairy products and ready-made foods, among others, may further increase the scope of reducing sodium consumption.

Finally, the maximum limits adopted in Brazil, compared to the lower limits in the Americas, in 2014 ²²22. Campbell N, Legowski B, Legetic B, Nilson E, L'Abbé M. Inaugural maximum values for sodium in processed food products in the americas. J Clin Hypertens 2015; 17:611-3., in addition to the most recent targets in force in other countries, such as the United Kingdom, United States, Argentina and South Africa ²⁰20. Peters SAE, Dunford E, Ware LJ, Harris T, Walker A, Wicks M, et al. The sodium content of processed foods in South Africa during the introduction of mandatory sodium limits. Nutrients 2017; 9:E404.^,2121. Food and Drug Administration. Draft guidance for industry: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods for voluntary sodium reduction goals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-target-mean-and-upper-bound-concentrations-sodium-commercially-processed (acessado em 18/Fev/2022).
https://www.fda.gov/regulatory-informati... ^,3030. Public Health England. Salt reduction targets for 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/604338/Salt_reduction_targets_for_2017.pdf (acessado em 18/Fev/2022).
https://assets.publishing.service.gov.uk... ^,3131. Argentina. Secretaría de Regulación y Gestión Sanitaria. Resolución Conjunta 1/2018. https://www.argentina.gob.ar/normativa/nacional/resolución-1-2018-317245/texto (acessado em 24/Jan/2020).
https://www.argentina.gob.ar/normativa/n... , show that there is technological feasibility for the production of foods with a lower sodium content. In 2017-2018, a regional study assessed that 81.2% of the products evaluated in Brazil met the regional sodium reduction targets in the Americas, considering categories such as breads, soups, mayonnaise, sweet and savory cookies, processed meats, morning cereals, requeijão, snacks and instant noodles ⁵⁰50. Madriz K, Ramos E, Blanco-Metzler, Adriana Saavedra L, Eduardo N, Tiscornia V, et al. El desafío de reducir el consumo de sal/sodio en la dieta de la población Latinoamericana. Proyecto - IDRC 108167 escalando y evaluando políticas y programas de reducción de sal en países de América Latina. 2016-2019. https://idl-bnc-idrc.dspacedirect.org/bitstream/handle/10625/58947/IDL-58947.pdf?sequence=2 (acessado em 18/Fev/2022).
https://idl-bnc-idrc.dspacedirect.org/bi... . Thus, there is still great scope for reducing the maximum sodium limits in products in Brazil, considering targets for the same categories in other countries.

The results of the analyses clearly show that the possible adoption of more restrictive targets, already adopted in other countries, and that reach the entire Brazilian market, through regulation, could multiply the potential impact in terms of prevented or delayed deaths by two or even close to four times.

Given that processed and ultra-processed foods and salt-based seasonings together account for close to 35% of sodium consumption in Brazil, it is also essential that national policies strengthen other measures to reduce sodium consumption. Considering other dietary sources of sodium, particularly added salt, and the consumption of ready-made food and preparations, which accounts for more than 65% of the consumed sodium, we will need multiple strategies that include food and nutritional education, dietary advice on health care services, measures within the framework of restaurants and food services (training of handlers, restricted use of salt shakers, reduced number of salt sachets, nutritional information on all preparations) and other regulatory measures (nutrition labeling on the front, regulated sale of food in canteens, regulation of the advertising of ultra-processed foods). Another possibility, which is using sodium substitutes, such as potassium and magnesium, despite promising results in the world ⁵¹51. Marklund M, Singh G, Greer R, Cudhea F, Matsushita K, Micha R, et al. Estimated population wide benefits and risks in China of lowering sodium through potassium enriched salt substitution: modelling study. BMJ 2020; 369:m824.^,5252. Mclaren L, Sumar N, Barberio AM, Trieu K, Lorenzetti DL, Tarasuk V, et al. Population-level interventions in government jurisdictions for dietary sodium reduction. Cochrane Database Syst Rev 2016; 9:CD010166., should be evaluated with caution in view of the high underdiagnosis of chronic kidney diseases in Brazil ⁵³53. Malta DC, Machado IE, Pereira CA, Figueiredo AW, Aguiar LK, Almeida WS, et al. Avaliação da função renal na população adulta brasileira, segundo critérios laboratoriais da Pesquisa Nacional de Saúde. Rev Bras Epidemiol 2019; 22 Suppl 2:E190010..

The main strengths of the analyses performed in this study are the use of the most recent national aggregated data on mortality and sodium intake, disaggregated by sex and age, as well as the relative risks of good quality meta-analyses. Mortality macrosimulation analysis (PRIME) uses methodologies based on the Global Burden of Disease study in relation to the application of relative risks associated with NCDs and population attributable ratios or fractions, which allow comparisons between countries and regions.

On the other hand, among its weaknesses are the premises that needed to be incorporated in the modeling in view of the unavailability of data, such as more recent information on sodium intake and dietary sources and relative risks specific to the Brazilian population. Thus, we assumed that the consumption of food categories would not change between 2008-2009 and 2017 and that the consumption reductions would be equal for all sexes and age groups. Thus, future studies should produce more conservative estimates of preventable deaths, since the reduction in sodium intake by adults in the younger ranges should be underestimated.

The study highlights the different impacts of strategies to reduce sodium content in processed and ultra-processed foods, according to limits adopted for sodium content and how to apply targets (voluntary or mandatory), in terms of deaths due to cardiovascular outcomes in the adult population in Brazil. In this sense, mandatory strategies, more comprehensive in terms of food categories and with more restrictive sodium limits would allow to prevent or delay even more than twice as many deaths, compared to deaths prevented or delayed by the continuity of the current voluntary strategy.

Ex ante policy evaluations, as in the scenario modeling applied in this study, can contribute greatly to the implementation of more effective and, with the incorporation of economic evaluations, more cost-effective policies. The cost of inaction or the adoption of measures with less effectiveness can have a large burden on the health of the population, so food and nutrition policies based on new evidence of potential impacts can strengthen health impacts and support decisions.

Acknowledgments

To the Brazilian Ministry of Health, the Brazilian Unified National Health System and the Brazilian Institute of Geography and Statistics, for the provision of information that allowed the analyses.

References

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