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The Food and Drug Administration (FDA) has responded to a health claim petition submitted on behalf of The Center for Magnesium Education and Research requesting that the Agency authorize a health claim characterizing the relationship between the consumption of magnesium and a reduced risk of high blood pressure.
The FDA has determined that current evidence supports a qualified health claim provided that the claim is appropriately worded to avoid misleading consumers. According to the Agency, “qualified health claims are supported by scientific evidence, but do not meet the more rigorous ‘significant scientific agreement’ standard required for an authorized health claim.”
To investigate the relationship between magnesium intake and risk of hypertension, the agency evaluated 85 intervention studies and 43 observational studies. A significant number of these studies were found to be inconclusive. While a small number of intervention studies showed a statistically significant lowering of blood pressure with magnesium intake, the majority showed no effect at all.
Based on these findings, the FDA intends to consider exercising enforcement discretion for the following qualified health claims for conventional foods and dietary supplements containing magnesium:
- “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.”
Additional information can be found in the Agency’s letter of enforcement discretion.
Reference
FDA announces qualified health claim for magnesium and reduced risk of high blood pressure. News release. US Food and Drug Administration. January 10, 2022. Accessed January 12, 2022. https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-qualified-health-claim-magnesium-and-reduced-risk-high-blood-pressure.
