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CEI Comments to the FDA on Voluntary Sodium Reduction Goals

Regulatory Comments and Testimony

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CEI Comments to the FDA on Voluntary Sodium Reduction Goals

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The Competitive Enterprise Institute (CEI) appreciates the opportunity to comment on the Food and Drug Administration’s Draft Guidance on sodium reduction goals. CEI is a 501(c)(3) non-profit public interest organization dedicated to promoting rational risk regulation and consumer choice. CEI has a long history of research and advocacy regarding the regulation of health and safety risks, with a particular emphasis on food and drug safety. We have frequently observed that attempts to limit exposure to certain risks unintentionally increase exposure to other, potentially more hazardous risks. In the case of sodium reduction, we believe the continued focus on reducing dietary salt for the population is not scientifically based and may be obscuring other, more effective, approaches to improving public health.

Although the FDA requested comments on eight specific questions, the Federal Register notice (FDA-2014-D-0055-0001) welcomed “comment on any issues related to the methods for developing the sodium targets.” In particular, CEI wishes to address the FDA’s stated goal of implementing the voluntary sodium reduction targets in order to “support the 2015-2020 Dietary Guidelines and the Healthy People 2020 recommendations of sodium intake of less than 2,300 mg per day for many individuals.” FDA states that, as noted by the Institutes of Medicine 2010 report, four decades of sodium reduction efforts by health agencies has failed.[1]

Furthermore, the draft guidance document notes that Americans consume the vast majority of their sodium in the form of prepared meals and snacks. Both of these assertions are true. However, we take issue with the subsequent logical leap that reducing sodium in processed, packaged, and prepared foods will:

  1. Reduce consumers overall sodium intake; and
  2. Result in lower rates of hypertension.

After conducting an extensive review of the scientific literature, available in our forthcoming paper on the efficacy of various public policy approaches to managing hypertension, we find that the overwhelming weight of evidence does not support the view that reducing sodium consumption to the level recommended in the Dietary Guidelines would improve public health. The paper concludes that to date, there is no evidence that, for the average normotensive individual (having normal blood pressure), lowering sodium intake from the average 3,400 mg per day to the recommended 2,300 mg per day, results in better health outcomes.

The current body of research on the effect of dietary sodium and sodium restriction on health yields conflicted results, at best. There has not been a single randomized control trial (RCT) performed examining how sodium reduction to the current recommended maximum affects health outcomes. Of the RCTs that have examined sodium restriction to under 3,000 mg a day, all performed on already hypertensive and/or obese patients. While they found small changes in blood pressure, they also found no benefit for all-cause mortality risk.[2]  Furthermore, an increasing body of observational research indicates that not only is lowering sodium below the average intake unhelpful for the majority of individuals, it may end up increasing their risk for negative health consequences for some.[3]

In addition to questioning the benefits of sodium reduction, we believe it is a mistake to assume that simply lowering the amount of sodium in prepared foods would lead consumers to lower their total sodium intake. Much research demonstrates that, outside of a controlled clinical setting, consumers unconsciously alter their dietary choices and behavior in an effort to maintain a constant level of sodium intake.[4] Reduced sodium consumption affects different individuals in different ways. Only an estimated 17 to 25 percent of the population is “salt sensitive”—they experience higher blood pressure with increased dietary sodium—while 75 percent are considered salt resistant and will experience no change in blood pressure with altered dietary sodium. However, an estimated 11 to 16 percent of the population are inverse salt sensitive, which means reduced dietary sodium can increase their blood pressure. With this heterogeneity in response to salt, trying to force a population-wide reduction in sodium availability in order to reduce incidences of hypertension would be ineffective at best and counterproductive at worst.

Lastly, while we believe that control of elevated blood pressure is vital to improving the heart health of our nation, the continued focus on sodium shifts the focus away from demonstrably more effective means of improving population blood pressure and health. Thus, we respectfully request the FDA to refocus its efforts toward approaches more likely to improve Americans’ health, such as the correction of nutrient deficiencies in the diet.  

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[1] Draft guidance for industry: voluntary sodium reduction goals: target for mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. U.S. Food and Drug Administration. July 1, 2016. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm494732.htm. Accessed October 16, 2016.

[2] Niels Graudal, “A radical sodium reduction policy is not supported by randomized controlled trials or observational studies: grading the evidence,” American Journal of Hypertension, May 2016 Vol. 29, No. 5. doi: 10.1093/ajh/hpw006

[3] Ibid

[4] [4] McCarron D.A., Weder A.B., Egan B.M., et al., “Blood Pressure and Metabolic Responses to Moderate Sodium Restriction in Isradipine-Treated Hypertensive Patients,” American Journal of Hypertension, Vol. 10, No. 1 (1997), pp. 68-76. https://www.ncbi.nlm.nih.gov/pubmed/9008250