22 months after we asked, the Food and Drug Administration answered!

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Nearly two years after we asked, the government has finally told us what it was doing!

Here’s what happened: We asked the Food and Drug Administration (FDA) to explain why it had issued its “Voluntary Sodium Reduction Goals.” The recommendations in that document, which call for a salt reduction in the average diet, must conform to scientific standards. The FDA isn’t allowed just to make its recommendations up. Instead, its recommendations must be based on scientific evidence.

It looked to us like the FDA had failed to conduct the peer review that was required for its recommendations about salt – and that it had also failed to take into account pervasive scientific disagreement about the effects of salt on health. We filed a disclosure request with the FDA so we could figure out what scientific evidence it was relying upon to justify its Voluntary Sodium Reduction Goals.

And after we filed our request, we waited.

And waited.

And waited.

And waited.

In fairness, the FDA sent us a note every now and then: the FDA is a faithful correspondent. Once we filed our request, the FDA wrote us back roughly two months later to tell us that it needed a little more time – another two months – to fulfil our request. So another two months went by, and then the FDA wrote us to tell us that it anticipated getting back to us in another two months. Wash, rinse, repeat.

Ultimately, we received 10 different letters from the FDA over the course of nearly two years, each one telling us that it needed to reset the clock for another two months.

And then, last week – nearly two years after we first asked, in 2021 – the FDA finally told us what it was doing. Notably, the FDA told us that what it was doing had little or no scientific basis.

More precisely, the FDA told us that it relied on two National Academy of Science Reports. The first report was nearly 20 years old. As the FDA told us, “In 2005, the then Institute of Medicine (IOM; now NASEM) set a Tolerable Upper Intake Level (UL) for sodium of 2,300 mg/day for individuals ages 14 years and older.” And that is true!

But it is also true that the more recent NASEM report (the 2019 report) states: “without a specific indicator of a toxicological effect of high sodium intake that can be used to establish a quantitative relationship, the committee concluded that a sodium UL cannot be established” (page 258); and “The committee concludes that there is insufficient evidence of sodium toxicity risk within the apparently healthy population to establish a sodium Tolerable Upper Intake Level (UL)” (page 259).

Importantly, the more modern analysis established a Chronic Disease Risk Reduction level of 2,300. That is very different than a UL. The Chronic Disease Risk Reduction level has nothing to do with the maximum safe level of salt consumption for the average person, however: the CDRR is the lowest amount that shows some evidence of a reduction in the risk of certain chronic diseases.

For a limited portion of the population – namely, those who are at high risk for or already have hypertension or heart disease – it makes sense to limit sodium to reduce your risk of making your own medical situation worse. But that is very different than a Tolerable Upper Intake Level, which identifies the toxicity risk in normal adult populations. As in many things, the best amount of sodium for an individual to consume depends on the facts of the specific situation—not a one-size-fits-all government decision.

The 2017 CEI study by Michelle Minton “Shaking up the Conventional Wisdom on Salt” goes into more detail as to problems with this kind of government approach to salt reduction.

The upshot of this is that what the government did is the equivalent of identifying a very sick population that needs prescription drugs – and then giving everyone in the United States, sick or well, that prescription.

You might say in response: “Big deal. Who needs salt, really? So what if it makes food taste better? Wouldn’t we all be better off if we cut way down on salt?”

Well, the evidence suggests that the answer to that question is: no. The 2019 government report suggests that some people may be harmed by lowering their sodium intake:

More recently, however, observational studies have emerged that suggest the possibility that lower intakes of sodium may increase the risk of harmful health outcomes. These studies suggest that the relationship between sodium intake and cardiovascular disease outcomes and mortality is not linear but presents a J or U shape. If confirmed, such a J- or U-shaped relationship might be supportive evidence to specify an AI that minimizes the risk of adverse outcomes at a low level of sodium intake. (page 222 internal, 239 external)…

A systematic review of the evidence of associations between low levels of sodium intake and status or adverse health outcomes was conducted for the European Food Safety Authority in preparation for establishing dietary reference values for sodium. The authors reported that low sodium intake may be associated with increased mortality, particularly all-cause mortality and cardiovascular disease mortality (Eeuwijk et al., 2013). This conclusion was based on two (out of three) National Health and Nutrition Examination Survey (NHANES) longitudinal follow-up studies showing an inverse relationship between sodium intake and all-cause mortality (Alderman et al., 1998; Cohen et al., 2006) and on three NHANES studies showing an inverse relationship between sodium intake and cardiovascular disease mortality (Alderman et al., 1998; Cohen et al., 2006, 2008). A major limitation for all three NHANES studies, however, is that estimates of sodium intake come from 24-hour dietary recall data (for limitation of different sodium intake measurement approaches, see Chapter 3). (pages 223-24 internal, 240-41 external)…

Two studies with overlapping populations reported a J or U shape between sodium intake and cardiovascular disease mortality (Lamelas et al., 2016; O’Donnell et al., 2014) and three studies (Lamelas et al., 2016; Mente et al., 2016; O’Donnell et al., 2014) with overlapping populations reported a U-shaped relationship between sodium intake and combined cardiovascular disease morbidity and mortality. (page 225 internal, 242 external)

In fairness, the 2019 report also states that there is some possibility of data errors that might bias its results. But what is clear to us is that the FDA’s recommendations are essentially unrelated to anything like scientific evidence or scientific results.

It’s distressing to discover, two years later, that the FDA’s recommendations in this area are basically groundless. They’ve definitely made food taste worse, and it appears that they’ve given us bad – and very possibly dangerous – health advice.