Public Comment From the Nutrition Coalition to FDA on Healthy Food Labels
To: The Food and Drug Administration
Re: 2025 Scientific Report by the Dietary Guidelines Advisory Committee
Date: April 22, 2025
The new rule would allow a “healthy” label on foods low in sugar, sodium, and saturated fat. The evidence set out below demonstrates that limits on two of these—saturated fat and sodium—would likely cause harm to human health.
On saturated fats:
Rigorous scientific reviews based on clinical trial data reveal no effect of saturated fat on cardiovascular or total mortality. A “State-of-the-Art” Journal of the American College of Cardiology review, whose authors include top nutrition experts, found “no robust evidence that current population-wide arbitrary upper limits on saturated fat consumption in the United States will prevent CVD or reduce mortality.”
Astrup A, Magkos F, Bier D, et al. Saturated Fats and Health: A Reassessment and Proposal for Food Based Recommendations. J Am Coll Cardiol. 2020 Aug, 76 (7) 844–857.
In all, nearly two dozen systematic reviews and meta-analyses by independent teams of scientists worldwide have concluded that 1) saturated fats have no effect on cardiovascular or total mortality, and 2) saturated fats have little to no effect on cardiovascular events. Further, higher saturated fat intake is associated with a lower risk of stroke. A link to all these reviews is here.
In addition, most of these reviews are listed in this paper I wrote, which reviews the history of the flawed hypothesis that saturated fats cause heart disease:
Teicholz, Nina. A short history of saturated fat: the making and unmaking of a scientific consensus. Current Opinion in Endocrinology & Diabetes and Obesity 30(1):p 65-71, February 2023. | DOI: 10.1097/MED.0000000000000791
Finally, the following paper reviews the deeply flawed history of the scientific reviews on saturated fats prepared for the US Dietary Guidelines for Americans. Among other things, the paper (whose authors include former members of previous Dietary Guidelines Advisory Committees) reveals that the US Department of Agriculture’s own review on saturated fats in 2020 misrepresented its own findings. Some 88% of the papers reviewed did not find a link between saturated fats and heart disease, yet the review concluded that the evidence against these fats was “strong.”
Dietary Saturated Fats and Health: Are the U.S. Guidelines Evidence-Based?
Astrup, A.; Teicholz, N.; Magkos, F.; Bier, D.M.; Brenna, J.T.; King, J.C.; Mente, A.; Ordovas, J.M.; Volek, J.S.; Yusuf, S.; Krauss, R.M. Dietary Saturated Fats and Health: Are the U.S. Guidelines Evidence-Based? Nutrients 2021, 13, 3305. https://doi.org/10.3390/nu13103305
On sodium:
The FDA rule would cap sodium at 0.23 grams per serving for most products. However, population-wide sodium reductions are unnecessary and can increase adverse health outcomes.
Quite a few large studies, including one in The Lancet, found that mortality risk increases with low sodium intake.
Mente, A., O’Donnell, M., Rangarajan, S., Dagenais, G., Lear, S., McQueen, M., Diaz, R., Avezum, A., Lopez-Jaramillo, P., Lanas, F., Li, W., Lu, Y., Yi, S., Rensheng, L., Iqbal, R., Mony, P., Yusuf, R., Yusoff, K., Szuba, A., … Yusuf, S. (2016). Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertension: a pooled analysis of data from four studies. In The Lancet (Vol. 388, Issue 10043, pp. 465–475). Elsevier BV. https://doi.org/10.1016/s0140-6736(16)30467-6
Finding: “Compared with moderate sodium intake, high sodium intake is associated with an increased risk of cardiovascular events and death in hypertensive populations (no association in normotensive population), while the association of low sodium intake with increased risk of cardiovascular events and death is observed in those with or without hypertension. These data suggest that lowering sodium intake is best targeted at populations with hypertension who consume high sodium diets.”
Lelli, D., Antonelli-Incalzi, R., Bandinelli, S., Ferrucci, L., & Pedone, C. (2018). Association Between Sodium Excretion and Cardiovascular Disease and Mortality in the Elderly: A Cohort Study. In Journal of the American Medical Directors Association (Vol. 19, Issue 3, pp. 229–234). Elsevier BV. https://doi.org/10.1016/j.jamda.2017.09.004
Conclusion: "Reduced sodium excretion is associated with increased mortality in a sample of community-dwelling older people, especially among the frail participants. High levels of sodium excretion are not associated with adverse outcomes in this population; therefore, sodium restriction might not be beneficial in older people."
Graudal, N., Jürgens, G., Baslund, B., & Alderman, M. H. (2014). Compared With Usual Sodium Intake, Low- and Excessive-Sodium Diets Are Associated With Increased Mortality: A Meta-Analysis. In American Journal of Hypertension (Vol. 27, Issue 9, pp. 1129–1137). Oxford University Press (OUP). https://doi.org/10.1093/ajh/hpu028
Finding: “Our study extends the IOM report by identifying a specific range of sodium intake (2,645–4,945 mg) associated with the most favorable health outcomes, within which variation in sodium intake is not associated with variation in mortality.”
“Both low sodium intakes and high sodium intakes are associated with increased mortality, consistent with a U-shaped association between sodium intake and health outcomes.”
Stolarz-Skrzypek, K. (2011). Fatal and Nonfatal Outcomes, Incidence of Hypertension, and Blood Pressure Changes in Relation to Urinary Sodium Excretion. In JAMA (Vol. 305, Issue 17, p. 1777). American Medical Association (AMA). https://doi.org/10.1001/jama.2011.574
Finding: “In this population-based cohort, systolic blood pressure, but not diastolic pressure, changes over time aligned with change in sodium excretion, but this association did not translate into a higher risk of hypertension or CVD complications. Lower sodium excretion was associated with higher CVD mortality…. Taken together, our current findings refute the estimates of computer models of lives saved and health care costs reduced with lower salt intake. They do also not support the current recommendations of a generalized and indiscriminate reduction of salt intake at the population level. However, they do not negate the blood pressure−lowering effects of a dietary salt reduction in hypertensive patients”
A 2017 technical report of the World Heart Federation, the European Society of Hypertension, and the European Public Health Association found “inconsistent evidence for further reductions below a moderate intake range (3- 5 g/day),” notably above the 2.3-gram daily cap in the U.S. Dietary Guidelines.
Mancia, G., Oparil, S., Whelton, P. K., McKee, M., Dominiczak, A., Luft, F. C., AlHabib, K., Lanas, F., Damasceno, A., Prabhakaran, D., La Torre, G., Weber, M., O’Donnell, M., Smith, S. C., & Narula, J. (2017). The technical report on sodium intake and cardiovascular disease in low- and middle-income countries by the joint working group of the World Heart Federation, the European Society of Hypertension and the European Public Health Association. In European Heart Journal (p. ehw549). Oxford University Press (OUP). https://doi.org/10.1093/eurheartj/ehw549
“Prospective cohort studies have identified the optimal range of sodium intake to reside in the moderate range (3–5 g/day), where the risk of cardiovascular disease and death is lowest. Therefore, there is consistent evidence from clinical trials and observational studies to support reducing sodium intake to less than 5 g/day in populations, but inconsistent evidence for further reductions below a moderate intake range (3–5 g/day).”
Quote from paper: “Sodium is an essential nutrient. This implies that there must be a ‘U’- shaped relationship between dietary sodium intake and cardiovascular events, but there is no consensus of where the minimum risks lies.”
Commenting on these and other findings, the Editors of The Lancet wrote in 2016: “There is no argument other than “excessive salt in the diet raises blood pressure”, and that strategies to reduce salt in individuals with hypertension prevent the cardiovascular consequences of the disease. However, the corollary that reducing sodium intake across populations will be beneficial to all, has been challenged with the assertion that doing so might indeed be harmful.”
O’Brien, E. (2016). Salt—too much or too little? In The Lancet (Vol. 388, Issue 10043, pp. 439–440). Elsevier BV. https://doi.org/10.1016/s0140-6736(16)30510-4
The evidence therefore indicates that including limits on saturated fat and sodium in the FDA “Healthy” food label would be harmful to human health.
Respectfully submitted,
Nina Teicholz