FDA allows qualified health claims for magnesium’s impact on high blood pressure

11 Jan 2022 --- The US Food and Drug Administration (FDA) no longer intends to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure – hypertension.

This is only relevant if the claims do not mislead consumers through inappropriate wording.

This move follows a petition sponsored by the dietary supplement trade association the Council for Responsible Nutrition (CRN) and other organizations on behalf of the Center for Magnesium Education and Research.

In response to the FDA’s approval, CRN’s senior vice president of scientific and regulatory affairs, Andrea Wong, says: “We are pleased FDA recognizes the role of magnesium in reducing the risk of hypertension in addition to this essential nutrient’s many other functions in the body.”

Labeling of foods and supplements
The petition proposed the following model claim to be used on the labels or in the labeling of conventional foods and dietary supplements containing magnesium: “Supportive but inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”The health claim backed by the FDA applies to conventional foods and dietary supplements that contain at least 20% of the daily value of magnesium.

In response to the petition, the FDA’s letter stated that due to the inconclusive and inconsistent evidence regarding magnesium intake, additional qualifying language should be included to convey the limits on the strength of the scientific evidence.

Additionally, the health claims apply to conventional foods and dietary supplements that contain at least 20% of the daily value of magnesium per reference amount customarily consumed.

The three qualified health claims are: 

• “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
• “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
• “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”

Determining health claims
To assess the intervention studies that focus on magnesium health claims, the FDA evaluated 85 intervention studies that investigated the relationship between magnesium intake and the risk of hypertension.

The letter from the FDA states that of the 85 intervention studies, conclusions could not be drawn from 47 studies because, in some studies, magnesium was given to subjects intravenously (through the vein) or intramuscularly (between the muscle) rather than by the oral route.Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension).

When ingested, the biological effects of magnesium cannot be determined from studies that use another route of administration without additional studies.

Therefore, scientific conclusions about the effect of magnesium on hypertension could not be drawn from these studies.

FDA’s approval of health claims
Previously, the FDA did not object to the health claims associated with consuming cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women. The decision was in response to a health claim petition submitted by Ocean Spray Cranberries.

Meanwhile, a roundtable of experts from Gencor, Lonza, Monteloeder and Lallemand Health Solutions stated that more clear health claim frameworks could increase consumer understanding and help them make more informed and accurate health choices.

High blood pressure remedies
Industry players have found that certain nutrients can lower blood pressure levels. Previously, a University of South Australia study determined a lack of vitamin D equates to increased blood pressure levels.

The FDA also implemented sodium reduction targets that changed from a consumer focus to food suppliers as too much sodium can lead to high blood pressure. 

By Nicole Kerr