One Year on, FDA Sodium Guidance Still Wanting

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It is the one year anniversary of the Food and Drug Administration’s (FDA) Guidance for Industry setting out goals to reduce sodium content in commercially processed, packaged, and prepared foods. CEI filed a request for correction (RFC) under the Information Quality Act (IQA) because the agency had failed to conduct a required peer review before issuing the guidance and because neither the agency’s own scientific review nor the resulting guidance acknowledged considerable scientific uncertainty in the field.

The IQA was enacted to ensure the “quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies.” The statute allows for an RFC to seek correction of inaccurate agency information.

Despite a requirement to respond and address the scientific issues raised in CEI’s RFC within 60 days, the FDA has done nothing. This delay is significant because the guidance could potentially harm public health.

Sodium is pervasive in the American diet, generally in the form of sodium chloride (salt). Since more than 70 percent of sodium intake is added during food manufacturing and commercial food preparation, the FDA guidance encourages “food manufacturers, restaurants, and food service operations” to reach concentration targets for various categories of foods. While the guidance is technically voluntary, the FDA has indicated that it will specifically encourage large food manufacturers and national restaurant and retail food chains to comply, likely resulting in significant public pressure.

But the guidance is premised on the questionable connection between sodium intake, blood pressure, and cardiovascular disease. It is clear that hypertension is a leading cause of heart disease and stroke, but it is far less clear that lowering sodium intake will lower blood pressure and cardiovascular disease in most people.

A 2020 review of randomized controlled trials found that reducing sodium intake had a minimal impact on people with normal blood pressure and resulted in only a small pressure decrease (about 3.5 percent) in people with elevated blood pressure.  Yet sodium reduction resulted in significant increases in cholesterol and triglycerides—both strongly associated with cardiovascular disease—especially in non-hypertensive people.

In fact, multiple studies suggest that both low and high sodium intake can lead to increased cardiovascular disease and death “in those with or without hypertension.” A prospective trial in the New England Journal of Medicine found that daily sodium intake between 3 and 6 grams (g) per day—a range consumed by most of the worlds’ population—was associated with a lower risk of cardiovascular events and death than was either a higher or lower level of intake. Average daily U.S. intake (3.4 g) falls at the lower end of that range.

In a recent study, researchers concluded that the optimal level of sodium intake is between 3 and 5 g per day. The authors concluded that since 80 percent of Americans have daily intake below 5 g, “efforts to reduce sodium intake in entire populations cannot be justified.”

The available evidence indicates that sodium reduction is most likely to benefit people who are already hypertensive and consume high sodium diets. Yet the FDA’s guidance targets everyone, creating the real possibility of increasing cardiovascular disease and deaths.

The time has come for the FDA to stop flouting its legal responsibilities and to start addressing CEI’s RFC and the outstanding scientific issues. The agency should withdraw its sodium guidance and start the peer-review process.